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C logo

JR QA Hardware Engineer

Clear BallotNashua, NH
We are looking for a motivated Junior Hardware Quality Engineer to join our Hardware Engineering team. This position serves as the designated entry point for recent university graduates or early-career engineers looking to launch a career in hardware development and testing. In this role, you will translate your academic knowledge into practical engineering skills under the close guidance and mentorship of senior team members. You will learn and gain hands-on experience in the hardware development of voting systems, from the initial design phase through prototyping and production readiness. Your responsibilities will include assisting with prototype testing, supporting internal validation efforts, and overseeing testing performed by external laboratories as part of formal certification processes. Throughout this role, you will also develop foundational knowledge of the Voluntary Voting System Guidelines (VVSG)-the federal standards that ensure voting systems are secure, reliable, and accessible-as well as the hardware testing requirements necessary to meet certification and regulatory compliance. What You'll Do ● Lab Operations & Hardware Management: You will be responsible for installing software on lab hardware, inspecting incoming electronic parts, managing lab inventory, and preparing hardware for demonstrations. ● Defect Reporting: You will log defects, report test results, and communicate findings clearly and promptly to senior team members. ● Root Cause Analysis Support: You will assist in reproducing hardware issues to support Root Cause Analysis (RCA) efforts and gather necessary information to aid in drafting Product Requirements Documents (PRDs). ● External Testing Opportunities: You will have the unique opportunity to shadow and oversee EMI/EMC and environmental testing at external laboratories to gain hands-on experience with regulatory certification processes. Qualifications Education: Bachelor's degree in Electrical Engineering, Mechanical Engineering, or a related technical field. ● Experience: 0-2 years of relevant experience. ● Technical Aptitude: A strong desire to learn voting system hardware and drive quality through hands-on engineering. You must possess a natural aptitude for breaking and taking things apart in a structured way to identify weaknesses. ● Test Instrumentation Proficiency: Hands-on experience with standard lab equipment, including oscilloscopes, digital multimeters (DMMs), and desktop power supplies. ● Hardware & Software Setup: Familiarity with installing drivers, OS, and software on hardware. ● Communication: Strong verbal and written communication skills are essential. You must be able to work effectively with other departments and clearly report test results and technical issues. ● Office Productivity Tools: Proficiency with Microsoft Office and/or Google Workspace applications (Word/Docs, Excel/Sheets) for documentation and data analysis. Nice to Have ● Previous Internships: Prior internship experience in hardware engineering or quality assurance. ● CAD & PCB Layout: Familiarity with Computer-Aided Design (CAD) tools and circuit board layout software is beneficial for understanding and reviewing mechanical and electrical components. ● Soldering & Rework: Experience with soldering and using rework stations, including the ability to perform basic soldering and rework on printed circuit boards (PCBs) for minor repairs or modifications. ● Schematic Interpretation: Interest in learning to read and interpret electrical schematics and mechanical drawings to trace signals and identify potential failure points. ● Agile & Tools: Experience working within Agile frameworks (Scrum or Kanban) using Atlassian products (Jira, Confluence). ● Linux OS: Familiarity with Linux operating systems.

Posted 2 weeks ago

Eli Lilly and Company logo

Associate QA Representative - Peptide Manufacturing

Eli Lilly and CompanyLebanon, TN

$65,250 - $169,400 / year

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Organization Overview Lilly is currently constructing an advanced manufacturing facility for production of API molecules located in Lebanon, IN (Lilly Lebanon API). This facility is Lilly's largest investment in manufacturing capacity and is intended to provide APIs for current and future products, including new modalities. This is a unique opportunity to be a part of the startup team for a greenfield manufacturing site, and the successful candidate will help to build the processes and facility to enable a successful startup into GMP manufacturing operations. Job Position Overview The Quality Assurance representative provides support to LP1 API Operations manufacturing and ensures quality systems and GMP compliance. The QA representative provides assistance and guidance in deviation investigations, change control proposals, procedure and master production recipe revisions, validations and batch dispositions. The QA representative's position is essential for maintaining quality systems, ensuring GMP compliance and in the preparation for inspections by various regulatory agencies. Responsibilities Provide direct quality oversight to LP1 manufacturing and assist others in interpretation of regulatory and corporate requirements. Provide quality guidance, technical support and recommendations to equipment and process issues and continuous improvement initiatives. Work with cross functional teams to implement QA objectives. Prepare for and participate in internal and external regulatory inspections. Basic Requirements Bachelors Degree in Engineering or science related field. 1+ years manufacturing experience. Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1. Additional Skills/Preferences Previous experience in pharmaceutical industry Previous experience in QA, TS/MS QC or Engineering Prior work with cGMPs or external regulations Demonstrated strong oral and written communication and interpersonal skills. Demonstrated decision making and problem solving skills Additional Information The normal schedule for this position is Monday-Friday, 8 hours/day. However, critical situations may require additional support beyond this normal schedule. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( https://careers.lilly.com/us/en/workplace-accommodation ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $65,250 - $169,400 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

Posted 1 week ago

Brigham and Women's Hospital logo

Outpatient Coding QA Specialist, Per Diem

Brigham and Women's HospitalSomerville, MA

$63,648 - $90,750 / year

Site: Mass General Brigham Incorporated Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham. Job Summary Responsible for developing, delivering, and maintaining coding education programs for medical coders and related staff. This role ensures coders are equipped with the knowledge and skills to assign accurate codes, comply with regulations, and support revenue cycle performance. Essential Functions Design, implement, and update education programs based on current coding guidelines, regulations, and industry standards. Lead training sessions, workshops, and webinars on CPT, ICD-10, HCPCS, compliance, and documentation improvement. Develop engaging e-learning modules and online content using modern tools and platforms. Provide direct support to coders through feedback on accuracy, compliance, and documentation use. Partner with Coding Education teams to reinforce the link between documentation quality and coding accuracy. Conduct coding audits, delivering actionable feedback to strengthen coder proficiency. Maintain ongoing education opportunities to keep staff current on coding updates and healthcare trends. Educate coders on compliance, ethics, and fraud prevention to uphold organizational standards. Qualifications Education Bachelor's Degree Health Information Management required or Bachelor's Degree Related Field of Study required Experience can be accepted in lieu of degree Licenses and Credentials Coding certification required: CCS-*, CPC, CPMA, CDEO, RHIA, or RHIT Experience 3+ years of coding experience; auditing or education experience strongly preferred. Knowledge, Skills and Abilities Strong instructional skills, including the ability to engage learners, present complex concepts clearly, and adapt teaching methods to various learning styles. In-depth understanding of provider-based billing concepts, professional coding standards, and the differing guidelines across outpatient and inpatient settings Excellent communication skills, both written and verbal, to deliver training content effectively and interact with diverse learners. Strong analytical skills to evaluate coding accuracy, identify training needs, and measure training effectiveness. Ability to collaborate effectively with coding staff, trainers, managers, and other stakeholders. Additional Job Details (if applicable) Remote Type Remote Work Location 399 Revolution Drive Scheduled Weekly Hours 0 Employee Type Per Diem Work Shift Day (United States of America) Pay Range $63,648.00 - $90,750.40/Annual Grade 6 At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package. EEO Statement: 0100 Mass General Brigham Incorporated is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran's Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at (857)-282-7642. Mass General Brigham Competency Framework At Mass General Brigham, our competency framework defines what effective leadership "looks like" by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.

Posted 1 week ago

OKX logo

Head Of Internal Audit Operations & Qa/Ip

OKXNew York, NY

$200,000 - $360,000 / year

Who We Are At OKX, we believe that the future will be reshaped by crypto, and ultimately contribute to every individual's freedom. OKX is a leading crypto exchange, and the developer of OKX Wallet, giving millions access to crypto trading and decentralized crypto applications (dApps). OKX is also a trusted brand by hundreds of large institutions seeking access to crypto markets. We are safe and reliable, backed by our Proof of Reserves. Across our multiple offices globally, we are united by our core principles: We Before Me, Do the Right Thing, and Get Things Done. These shared values drive our culture, shape our processes, and foster a friendly, rewarding, and diverse environment for every OK-er. OKX is part of OKG, a group that brings the value of Blockchain to users around the world, through our leading products OKX, OKX Wallet, OKLink and more. About the Opportunity We are seeking a strategic and highly organized Head of Internal Audit Operations & QA/IP to join our Global Internal Audit (IA) team. This is a critical role responsible for supporting the efficient and effective functioning of the IA department by managing its reporting, resource planning, budget, technology, initiation of the QA/IP programme and operational logistics. This role is essential for enabling the IA function to operate smoothly, communicate its insights effectively to senior management and the Audit Committee, drive continuous improvement in compliance/execution and demonstrate its value to the organization. Reporting to the Head of Audit - Professional Practice Group (HoA-PPG), you will be the central pillar supporting the IA leadership team. You will drive operational excellence, manage key performance indicators (KPIs), develop frameworks for driving quality/iterative improvements and ensure our team has the tools, data, and support needed to deliver high-impact work. What You'll Be Doing Planning, Reporting & Stakeholder Communications Lead the process for developing the risk-based Annual Audit Plan, ensuring alignment and evolution with organizational strategy, IA policy and internal audit standards. Lead the preparation and consolidation of all reporting for the Audit Committee and senior executive management, including drafting presentation decks, dashboards, and narratives. Manage the function's system for tracking audit findings and recommendations. Prepare regular reports for management on the status of remediation efforts. Develop and maintain a dashboard of the IA function's KPIs (e.g., plan completion, budget vs. actual, team utilization, audit finding themes). Operations & Resource Management Own and maintain the master internal audit plan, tracking the status, timelines, and resource allocation for all active and planned projects. Lead the function's resource management and scheduling process, forecasting team capacity, identifying potential bottlenecks, and working with IA leadership to optimize resource deployment. Manage the complete lifecycle of the IA function's budget, including annual planning, monthly forecasting, tracking actual expenditures, processing invoices, and managing vendor relationships. Quality Assurance & Improvement Programme Establish the foundations for ensuring our IA activity conforms with the Institute of Internal Auditors (IIA) International Standards for the Professional Practice of Internal Auditing (the Standards) and our own internal methodology: Iteratively develop, document, and roll out the foundational components of a QAIP framework, policies, and procedures in line with Global Internal Audit Standards. Design and implement "ongoing monitoring" processes, including checklists and scoring rubrics for in-flight and end-of-engagement file reviews. Establish and track key quality metrics (KPIs) to monitor the health and performance of the IA function. Conduct the function's initial "periodic self-assessment" to create a baseline of conformance with the Standards. Socialise the QAIP with the IA team, focusing on its role as a collaborative tool for improvement. Technology & Data Enablement Act as the primary system administrator and "super user" for the Internal Audit management software (e.g., AuditBoard, TeamMate, Workiva). Provide training and support to the IA team on audit methodology, tools, and software. Partner with the IA team to identify and leverage data analytics opportunities to enhance audit efficiency and insight. Manage the IA team's internal knowledge-sharing platform (e.g., SharePoint, Confluence), ensuring methodology documents, templates, and training materials are organized and up-to-date. People & Culture Coordinate the end-to-end onboarding process for new hires within the IA team. Manage talent strategy by overseeing the department's training curriculum development, learning development/sourcing and delivery, professional certification tracking (CIA, CISA, etc.), and competency mapping. Drive initiatives related to team engagement, inclusion and positive culture Project manage key departmental initiatives, strategic projects, and team-wide meetings or events. Cross-functional Coordination & ProjectsOperations & Resource Management Coordinate the IA function's contribution to other corporate reports (e.g., annual reports, risk management updates). Represent IA's contribution to combined assurance, coordinating with Risk, Compliance, and Legal to ensure a unified approach to risk coverage and minimize "audit fatigue" for business owners. Special Projects: Lead ad-hoc high-priority projects or investigations as directed by the HoA-PPG and CAE. What We Look For In You Bachelor's degree in Business, Finance, Project Management, Law or a related field. Minimum of 8 years of experience in a programme management, operations, business management, change management, implementation or "chief of staff" role. Experience within an internal audit, risk management, compliance, or professional services (e.g., Big 4) function is strongly preferred. Advanced proficiency in creating executive-level reports and presentations, with expert-level skills in Microsoft PowerPoint and Excel. Experience with data visualization tools (e.g., Power BI, Tableau) is highly desirable. Proven experience managing departmental budgets, resource planning, and project coordination. Experience as a system administrator for GRC or audit management software is a significant plus. Experience in having successfully undergone or managed an External Quality Assessment (EQA) is highly desirable. Professional certification (e.g., PMP, CIA, CISA) is highly preferred. Nice to Haves Project Management & Organization: Exceptional organizational skills. Meticulous attention to detail with the ability to manage multiple competing priorities and deadlines in a fast-paced agile environment spanning multiple timezones. Analytical Skills and Critical Thinking: Excellent analytical skills with the ability to synthesize data from multiple sources (e.g., plan status, findings, budget) into clear, insightful, and actionable reports. Communication and Interpersonal Skills: Exceptional written and verbal communication. Must be able to distill complex information into clear and concise messages for executive audiences. Stakeholder Management & Service Orientation: A proactive, service-oriented mindset focused on enabling the team's success. Ability to build strong, collaborative relationships with IA team members and key stakeholders across the business. Technical Acumen: Strong understanding of project management principles, financial management, and resource planning. Ability to quickly learn and manage new technologies. Strategic Thinking: Ability to translate high-level strategy into actionable departmental workflows. Professionalism and Ethics: Unquestionable integrity, objectivity, and commitment to the IIA's Code of Ethics. Ability to handle sensitive information with complete confidentiality. Perks & Benefits Competitive total compensation package L&D programs and Education subsidy for employees' growth and development Various team building programs and company events Wellness and meal allowances Comprehensive healthcare schemes for employees and dependants More that we love to tell you along the process! OKX Statement: OKX is committed to equal employment opportunities regardless of race, color, genetic information, creed, religion, sex, sexual orientation, gender identity, lawful alien status, national origin, age, marital status, and non-job related physical or mental disability, or protected veteran status. Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records. The salary range for this position is $200,000 - $360,000 The salary offered depends on a variety of factors, including job-related knowledge, skills, experience, and market location. In addition to the salary, a performance bonus and long-term incentives may be provided as part of the compensation package, as well as a full range of medical, financial, and/or other benefits, dependent on the position offered. Applicants should apply via OKX internal or external careers site. Notice: All official OKX vacancies are published on this website. While roles may appear on selected third-party platforms from time to time, information on other sites may be inaccurate or outdated. If in doubt, please apply directly through our official careers website. Information collected and processed as part of the recruitment process of any job application you choose to submit is subject to OKX's Candidate Privacy Notice.

Posted 1 week ago

N logo

Executive Director, Clinical QA

Neurocrine Biosciences Inc.San Diego, CA
Who We Are: At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering for people with great needs. What We Do: Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, endometriosis and uterine fibroids, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X and Facebook. (*in collaboration with AbbVie) About the Role: Provides vision, strategic planning and management for departmental initiatives. Responsible for developing and setting strategy and operating plans for Clinical QA, and establishing compliance, procedures, and quality leadership. Responsible head for the Clinical QA matters for building and leading a team of highly trained and skilled quality professionals in order to implement the quality systems and perform activities necessary to ensure compliance and to ensure QA support of clinical study teams. Prepares and leads the company through pre-approval inspections and clinical audits. Coordinates interdepartmental activities both internally and externally with regulatory, clinical, drug safety, and medical affairs to ensure clinical activities and internal functions meet quality standards and reflect risk-based principals. Ensures budget, schedules, and department performance requirements are met. Additionally, mentors and coaches all employees within the QA group and provide leadership and management within the entire team. _ Your Contributions (include, but are not limited to): Your Contributions (include, but are not limited to): Drives the strategic vision and direction for Clinical QA group Develops, executives, evaluates and adjusts strategy for Clinical QA and establishes strong, effective working relationships with internal and external stakeholders to achieve GCP compliance and Quality objectives Leads effort in developing, implementing and communicating of the GCP QA vision, goals, core capabilities, and values while championing a strong Quality Culture Partners with Clinical Development, Clinical Operations, Biostatistics, Pharmacovigilance, and Regulatory Affairs stakeholders regarding compliance issues and provides quality guidance and expert interpretation of GCP regulatory requirements and expectations Responsible for preparations and direct participation in regulatory inspections, which may include reviewing inspection readiness planning, mock inspections, performance of pre-approval inspections, and risk-based management of program inspection quality events Leads and project manages the development, implementation, and enhancements to the clinical QMS Participates in the evaluation, selection, compliance audit strategy, and oversight of global clinical investigators, contract clinical laboratories, and CROs Monitors the regulatory status of principal investigators and intervenes when sub-optimal performance is identified. Assists in remediation and corrective action plans to ensure all parts of the study are conducted properly Supports investigational new drug applications, ex-US clinical trial applications (CTA), and related correspondence from global regulatory authorities Develops metrics and trending of compliance activities for Clinical Quality Assurance and communicate these to upper management as necessary Performs investigator site and vendor audits to assess the integrity of the study data and to determine if studies are being conducted in compliance with applicable GCP/regulatory requirements and guidelines, study protocols, monitoring plans and applicable policies/procedures Directs and oversees compliance activities related to drug safety and pharmacovigilance, phase IV studies and investigator-initiated trials Oversees and may perform the internal audits designed to determine if policies/procedures, systems, reporting and/or the conduct of the investigational studies are executed with compliance to GCP principles/regulations Other duties as assigned Requirements: RN, BSN, BS/MS, or BA degree or equivalent experience in scientific or health care field and 17+ years of industry experience including GCP leadership roles within a development and commercial GCP environments. Extensive GCP audits and inspections or related experience required. Experience with developing and implementing GCP QA systems, process' and procedures. Previous managerial experience also required OR Masters Degree in similar field as noted above and 15+ years of experience as noted above In-depth knowledge of all Clinical Trial related FDA regulations, ICH Guidelines, and experience with international GCP regulations and guidelines is required Ability to create a comprehensive audit program and carry out audits of investigator sites and clinical research vendors for Phase I-IV studies. Requires an in-depth knowledge of auditing principles, techniques and communication skills to clearly and efficiently convey findings and report deficiencies to investigator sites as well as management Ability to work closely with both internal and external personnel to increase the level of compliance and cooperation while creating opportunities to improve operations and implementation Excellent understanding of domestic and international regulations and guidance documents, with a focus on FDA & EMA regulations Strong pharmaceutical industry experience with a working knowledge of quality systems and regulatory compliance requirements for clinical quality assurance Strong knowledge of all regulations pertaining to GxP's and current industry trends as related to pharmaceutical, biological and gene therapy products Demonstrated knowledge and expertise in GCP, as well as GLP and/or GMP systems throughout the product lifecycle Demonstrated analytical ability, strong leadership skills, exceptional communication skills, creativity, and the ability to effectively manage and implement multiple projects Ability to solve problems and troubleshoot issues Expert at managing complex and multiple work streams in changing circumstances Proven ability to cultivate and develop relationships with cross functional teams and vendors Demonstrated leadership ability to identify, manage and develop QA teams Recognized as an internal thought leader with extensive technical and business expertise within a strategic organization Demonstrated in-depth knowledge of own function, business / commercial / scientific expertise to solve critical issues successfully and innovatively Evaluates key business / scientific challenges and completes complex, ambiguous initiatives having cross-functional impact Excellent interpersonal skills and competent confident communication when interacting with regulatory authorities as well as internal leaders and external partners Analyzes complex situations / issues and effectively communicate situations / issues, along with potential recommendations, to various functional groups Provides mentorship, acts as a trusted advisor, and is an advocate for Quality with the ability to influence change and invest deeply in the company mission Excellent relationship building and persuasion skills with the ability to motivate and influence others; demonstrated record of overcoming resistance to change and driving the adoption of new processes from a position of indirect or informal authority Self-motivated, hands-on critical thinker and problem solver, with the ability to lead by example, with an enthusiastic, optimistic outlook, and a collaborative style Demonstrated ability to integrate and apply feedback in a professional manner Holds self and others accountable for adherence to high work and ethical standards #LI-KM1 Requirements: Neurocrine Biosciences is an EEO/Disability/Vets employer. We are committed to building a workplace of belonging, respect, and empowerment, and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don't line up to exactly what we have outlined in the job description. _ The annual base salary we reasonably expect to pay is $246,300.00-$336,000.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 35% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.

Posted 30+ days ago

A logo

QA Operations Associate I

American Regent LaboratoriesHilliard, OH
Nature and scope This position is responsible for ensuring the overall Quality in their assigned areas through the execution of site policies and procedures, programs and work instructions. Ensures all processes and products meet specifications and that products are produced in accordance with GMP requirements. Essential duties and Responsibilities Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Achieve and maintain packaging line and inspection room clearance qualification Conduct accurate verifications and checks as well as accurate process inspections Conduct accurate packaging AQL inspections Identify out of specification product, ensuring segregation and escalation, as required Ensure errors and omissions are resolved according to Standard Operating Procedure (SOP) requirements Ensure all work is performed and documented in accordance with existing Company policies and procedures, as well as cGMP, health and safety requirements. Conduct component and raw material release Conduct chart monitoring, ensuring escalation, as required Support product shipping activities and perform quality related oversight and verifications Generate logbooks and sheets/labels Review Bills of Materials Basic knowledge of cGMPs and supporting regulatory documents Achieve and maintain clean side gown and sterile side gown qualifications Achieve and maintain Class A qualification Perform room, area and equipment clearances. Participate in Media Fill and maintain qualification Able to perform tasks with minimal error rate. Perform any other tasks/duties as assigned by management. We all must embrace the QUALITY culture. Qualifications and Requirements High School Diploma or GED equivalent required. Associates or Bachelor's Degree preferred. Minimum 1 year work experience in a FDA regulated environment or similarly regulated area is preferred. Must be able to do work independently. Intermediate skills in Microsoft Word and Excel are required. Excellent organizational, interpersonal and communication skills (written and oral) required. Ability to take feedback constructively and function in a team oriented work environment. Ability to work overtime as needed. Physical Environment and Physical Requirements Employee must be able to occasionally lift and/or move up to 25 pounds. Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. PPE and Respirators are essential for the health and safety of employees. Specific vision requirements include 20/20 near vision (can be corrected with eyeglasses or contacts) and color vision. Employees must maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly. American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status. Applicants have rights under Federal Employment Laws. FMLA poster: https://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdf Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov) Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf Alert: We're aware of individuals impersonating our staff to target job seekers. Please note: All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address. Our recruiting process includes multiple in person and/or video interviews and assessments. If you are unsure about the legitimacy of a message, contact John Rossini at jrossini@americanregent.com before responding. We never request payment, bank information, or personal financial details during our offer process. Your security is important to us, and we encourage you to stay vigilant when job searching. American Regent Inc. endeavors to make https://careers.americanregent.com/ accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email hrtalentacquisition@americanregent.com.

Posted 3 weeks ago

Gilead Sciences, Inc. logo

QA Senior Specialist - External Quality, Strategy, Processes And Metrics

Gilead Sciences, Inc.Foster City, CA

$136,340 - $176,440 / year

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Job Description Responsibilities: The responsibilities of the Senior QA Specialist is to maintain commercial product specifications current in all GMP systems, as well as the management of SAP workflow to ensure compliance to product dossiers and enable timely release of products. Lifecycle management of specification include revisions based on feedback from health authorities during post approval changes and submission of a commercial products to additional countries, or from continuous process verification where a change to approved specification is warranted. The Senior QA Specialist needs to manage change control record in GVault pertaining to specification revision, and must be well verse in using the SAP system. Knowledge with specification setting and experience with assisting the response to health authority inquiries related to specifications are beneficial. Specific Education & Experience Requirements: 7+ years of relevant experience in a GMP environment related field and a BS or BA. 5+ years of relevant experience and a MS. Preferred Requirements: Performs a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements Participates in writing or suggesting changes to controlled documents (e.g., SOPs, Specifications, Methods, etc.) as needed, to ensure defined quality objectives are met. Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs). May participate in the writing of annual product reviews and the development of training programs regarding all aspects of producing quality products. May assist or lead compliance audits as required. May interface with regulatory agencies as required. Interfaces with internal sites and contract manufacturers to address inquires from health authorities during product submission and post approval changes. Proficient in application of QA principles, concepts, industry practices, and standards. Demonstrates ability to effectively manage multiple projects/priorities. Has proven analytical and conceptual skills. Demonstrates understanding of international quality systems regulations to adopt best in class systems/processes. Demonstrates excellent verbal communication, technical writing and interpersonal skills. Demonstrates working knowledge and good proficiency in Microsoft Office applications. Knowledge of Six Sigma, Define-Measure-Analyze-Improve-Control (DMAIC) methodology, performance measures and quality improvement statistical methods are beneficial. Working knowledge of Risk Management tools (e.g., Hazard Analysis and Critical Control Points (HACCP) and / or Failure Mode Effects Analysis (FMEA)) is beneficial. Knowledge with IND/NDA/BLA submission process is desired. The salary range for this position is: $136,340.00 - $176,440.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*. For additional benefits information, visit: https://www.gilead.com/careers/compensation-benefits-and-wellbeing Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans. For jobs in the United States: Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance. For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law. Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team. Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion. For Current Gilead Employees and Contractors: Please apply via the Internal Career Opportunities portal in Workday.

Posted 2 days ago

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Specialist, QA Process Excellence

Legend Biotech CorpRaritan, NJ

$75,972 - $99,713 / year

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide. Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking a Specialist, QA Process Excellence as part of the Quality team based in Raritan, NJ. Role Overview The QA Process Excellence Specialist III role is an exempt level position with responsibilities for providing quality oversight for the manufacturing process and associated technical activities within a cell therapy manufacturing plant to support both clinical and commercial requirements in a sterile GMP environment. This role will also provide oversight of technical operations activities including data or document review, risk assessments, CAPAs, and continuous improvement activities. They will be a subject matter expert for the manufacturing process and provide quality oversight for technical teams. Key Responsibilities Provide Quality Oversight and technical expertise to the Technical Operations and Manufacturing Teams in support of technical activities. Provides guidance on industry best practices, and quality requirements for maintaining a compliant state for manufacturing operations. Provide expertise related to investigations and deviations occurring during routine manufacturing and protocol-driven activities such as tech transfer and process validation. Assist in the development of process, operational, and quality improvements for manufacturing. Assist in the review and development of process-related protocols and documentation. Provide technical quality oversight for electronic batch records. Support manufacturing and technical operations teams in trouble shooting and resolving complex scientific / technical problems. Evaluates quality processes and system standards to ensure compliance with applicable internal standards, industry standards, and global regulations. Provide Quality Oversight for batch records, change controls, SOPs, non-conformances, risk assessments, and CAPAs associated with manufacturing and technical operations and ensure effectiveness of related actions. Ability to handle multiple priorities daily while being flexible and responsive to frequently shifting priorities. Ability to work independently perform assigned tasks. Perform tasks in a manner consistent with the safety policies, quality systems, and cGMP requirements. May support CSV activities as needed. May support equipment qualification activities as needed. Drive continuous improvement. Requirements A minimum of a Bachelor's Degree in Science or equivalent technical discipline is required. 5+ years relevant work experience or equivalent. It is preferable that the candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy. A portion of the 5 years must include quality assurance experience. Strong knowledge of cell therapy processes strongly preferred. Experience with Manufacturing Execution Systems (MES) design/development and validation is preferred. Experience with Computer System Validation (CSV) is a plus. Knowledge of cGMP regulations and FDA/EU guidance related to GMP manufacturing of biopharmaceuticals. Experience reviewing/auditing GMP documentation. Strong interpersonal and written/oral communication skills. Ability to quickly process complex information and make critical decisions with limited information. Ability to work independently and escalate to management when required. Detail-oriented and able to follow procedures closely. Ability to identify and assess possible gaps and work collaboratively to address such issues. Must be highly organized and capable of working in a team environment with a positive attitude. Strong proficiency with using Microsoft Office applications. #Li-RP1 #Li-Onsite The base pay range below is what Legend Biotech USA Inc. reasonably expects to offer at the time of posting. Actual compensation may vary based on experience, skills, qualifications, and geographic location. The company reserves the right to modify this range as needed and in accordance with applicable laws. Performance-based bonus and/or equity is available to employees in eligible roles. The anticipated base pay range is: $75,972-$99,713 USD Benefits Benefits include medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer eight (8) weeks of paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays. Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work. Please note: These benefits are offered exclusively to permanent full-time employees. Contract employees are not eligible for benefits through Legend Biotech. EEO Statement It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances. Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company. Legend may adjust base salary or other discretionary compensation at any time based on individual, team, performance, or market conditions. For information related to our privacy policy, please review: Legend Biotech Privacy Policy.

Posted 30+ days ago

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Associate QA Operations Director- Computer Systems And Data Integrity

Exelixis Inc.Alameda, CA

$156,000 - $222,000 / year

SUMMARY/JOB PURPOSE (Basic purpose of the job): This Associate Director, Computer Systems and Data Integrity (DI) is accountable for driving a risk based, comprehensive implementation of the DI program meeting cGxP regulations, and responsible for Computer System Validation (CSV) oversight by setting and maintaining a company strategy, QA oversight, evaluating CSV regulatory landscape and revising company policies and procedures accordingly. Works cross functionally to establish, implement and report metrics to measure compliance and continuous improvement, assess, resolve and/or escalate CSV/DI issues and associated risks. Represents QA as the QA Partner (Primary Point of Contact), speaking One Voice for Quality, for Exelixis business stakeholders, represents QA in an outwardly and business-facing capacity, in strategic and decision forums, and triages communication between Exelixis business functions, internally or externally, and QA, to provide and ensure delivery on company core goals and pipeline deliverables. ESSENTIAL DUTIES/RESPONSIBILITIES: Responsible for generating a risk-based strategy across the GxP landscape that identifies and manages issues and risks while driving continuous improvement to ensure continuous compliance to global DI standards and aligning with key stakeholders. Reviews and approves validation deliverables (URS, FS, IQ/OQ/PQ, etc.). Monitors emerging regulatory health authority requirements for GxP computerized systems, process controls, and compliance for data creation and handling, and ensures that procedures are revised accordingly Team player and driver, identifies KPIs, sets metrics and success criteria Identifies, mitigates, escalates and resolves issues and risks Authors and review CSV, DI policies, procedures, lifecycle documents SME for Health Authority inspections and audits Delivers CSV/DI training as required Responsible for establishing and maintaining a program compliant with Title 21 CFR Part 11 for systems used to generate, modify, maintain, archive, retrieve, or transmit GxP data. Understands global Health Authority regulations and guidance as it pertains to computer system requirements and provide guidance. Provides QA support for all Exelixis GxP Computer systems and platforms Establishes strong collaborative relationships with internal and external stakeholders to ensure timely documentation, escalation and resolution of quality issues SUPERVISORY RESPONSIBILITIES: No supervisory responsibilities. EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: Education: BS/BA degree in Biology, Computer Science, Education, Learning & Development, Sciences, or related discipline and 11 years of related experience; or MS/MA degree in Biology, Computer Science, Education, Learning & Development, Sciences, or related discipline and 9 years of related experience; or Equivalent combination of education and applicable experience. Experience: Significant management experience within the pharmaceutical and biotech industries required Oncology experience is required. Experience in Portfolio, Project and/or Alliance Management. Experience using standard data querying and management tools including SAS or SQL. Knowledge, Skills and Abilities: Thorough knowledge and understanding of drug development process, GxP Global Regulatory Requirements and regulations related to DI/CSV. Proven ability to manage multiple competing priorities, evaluate data to detect weak signals, blind spots and rapidly escalate cumulative risks. Demonstrated ability to lead through change by engaging others, assessing unforeseen situations, continuously learning to achieve a goal, and drive for results. Excellent written, verbal and presentation communication skills, able to translate and communicate complex concepts across all levels of the organization. Successfully engages and collaborates effectively with cross functional teams. Proven ability to interpret and analyze data, provide feasible and effective technical solutions. Applies strong analytical thinking to develop technical and/or business solutions to complex problems. Identifies and implements methods, techniques, procedures and evaluation criteria to achieve results. Work Environment/Physical Demands: Our office is a modern, open-plan space that foster collaborations and creativity. Teams work closely together, sharing ideas and solutions in a supportive atmosphere. We provide all necessary equipment, including dual monitors and ergonomic chairs, to ensure a comfortable workspace. Travel as required 5-10% of time #LI-HG1 If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us! Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $156,000 - $222,000 annually. The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors. In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year. DISCLAIMER The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job. We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.

Posted 1 week ago

Michels Corporation logo

Qa/Qc Manager - Michels Construction, Inc.

Michels CorporationMilwaukee, WI
If you like variety and challenge and take satisfaction from knowing your work supports modern construction, consider joining the Michels Construction, Inc. team. Michels Construction, Inc. gets projects off to strong starts by designing and constructing foundations and industrial facilities. The end product might not be a focal point, but it will be essential. Our work improves lives. Find out how a career at Michels Construction, Inc. can change yours. The Quality (QA/QC) Manager is responsible for assisting operations with implementation and compliance of existing quality assurance/quality control (QA/QC) programs. This position conducts jobsite and facility visitations, inspections and assessments to ensure adherence to quality expectations in accordance with project specifications and industry standards. You will also be responsible for conducting and supporting QA/QC orientations, progress update meetings and related QA/QC trainings. In addition, you will perform audits to identify areas of concern and take appropriate corrective actions independently, while documenting all findings. Key for success in this role is the ability to understand and apply appropriate industry specific standards as well as establish working relationship with Michels Construction, Inc. project team (i.e., Project Manager, Foreman, General Foreman, Superintendent), customers, vendors, and regulatory authorities. Why Michels Construction, Inc.? We support dynamic and growing industries We are family owned and operated We invest an average of $5,000 per employee on training each year We reward hard work and dedication with limitless opportunities We are a part of the Michels family of companies - one of North America's largest, most diversified energy and infrastructure contractors We offer a comprehensive benefits program, including Health, Dental, Life, Flexible Spending Accounts, Health Savings Account, Short Term and Long-Term Disability Insurance, 401(k) plan, Legal Plan, and Identity Theft and Monitoring Plan. Depending on your positions and location you may participate in a different benefit plan Why you? You thrive in fast-paced environments under tight deadlines You relish new challenges and evolving technology You enjoy collaborating and communicating with your teammates You like to know your efforts are noticed and appreciated What it takes: QA/QC experience in construction industry 5+ years of Industry experience and training Ability to travel extensively (75% or more) QA/QC Certification in ISO or the American Society for Quality Proficient in Microsoft Office Suite Must possess a valid driver license for the type(s) of vehicles which may be driven, and an acceptable driving record as determined by the Michels Review Team AA/EOE/M/W/Vet/Disability AA/EOE/M/W/Vet/Disability https://www.michels.us/website-user-privacy-policy/

Posted 3 weeks ago

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Qa/Qc Inspector-Mission Critical

Alston Construction Company, IncAtlanta, GA
About Alston Construction: Alston Construction Company is a nationwide general contractor, with more than 20 offices coast to coast. For over 35 years we have delivered on our promises to our employees, clients, and business partners. We offer extremely competitive salaries, a superb benefits package, and a great place to work! In addition to routinely receiving awards for our projects and safety performance, we have also received numerous "Best Places to Work" awards! We look for passionate construction professionals who share our core values, to include: commitment, integrity, teamwork, and respect. As our CEO, Paul Little, says "In order to be successful at Alston Construction, you must enjoy seeing success in others." If this sounds like you and what you're looking for, we'd love to hear from you! Our top tier benefits package includes medical, dental, vision, prescription safety glasses, short-term disability, long-term disability, life insurance/AD&D, HSA, health FSA, dependent daycare FSA, EAP, 401(k), Roth 401(k), After-Tax Roth In-Plan Conversion; paid vacation and sick time, paid holidays, tuition reimbursement, Tickets at Work, paid Identity Theft Protection (family coverage) and more! Job Title: QA/QC Inspector Job Summary: The QA/QC Inspector is responsible for inspecting construction work to ensure compliance with contract documents, approved submittals, applicable codes, and company quality standards. This role performs routine and targeted inspections of work in place, verifies conformance to plans and specifications, documents deficiencies, and supports corrective actions. The QA/QC Inspector works closely with project management, field supervision, subcontractors, and third‑party inspectors to uphold quality expectations and minimize rework-particularly on technically complex and mission‑critical projects. Essential Duties and Responsibilities: The QA/QC Inspector will be primarily involved with performing the following duties and responsibilities: Perform daily and scheduled quality inspections of work in place across all construction phases. Verify materials, installations, and workmanship comply with approved drawings, specifications, codes, and standards. Inspect mechanical, electrical, plumbing, architectural, and structural scopes as applicable to the project. Document inspection results, deficiencies, and observations using company QA/QC systems and reports. Track non‑conforming work and verify corrective actions through closure. Coordinate inspections and testing with subcontractors, consultants, and third‑party inspection agencies. Review approved submittals and inspection test plans (ITPs) to confirm installation requirements. Participate in pre‑installation meetings and quality planning sessions. Support commissioning, punch list, and closeout inspections. Maintain accurate and organized quality documentation in accordance with company requirements. Communicate quality concerns promptly to field supervision and project management. Promote adherence to quality standards and continuous improvement initiatives. Other duties as assigned Education, Experience, and Certifications: High school diploma or equivalent required; technical degree or coursework preferred. Minimum of 3-5 years of experience in construction inspection, quality control, or field supervision. Experience on commercial, institutional, healthcare, infrastructure, or mission‑critical projects preferred. Working knowledge of construction codes, inspection requirements, and testing procedures. Alston Construction is an Equal Opportunity Employer.

Posted 3 weeks ago

Performance Food Group logo

Specialist, Qa/Qc

Performance Food GroupDenver, CO
Job Description The QA/QC Specialist is responsible for day-to-day execution of food safety, quality control, and coffee quality standards within the roasting and packaging operation. This role supports regulatory compliance while actively monitoring roast quality, sensory performance, and process consistency. This is a highly hands-on role that works closely with Production and Operations to ensure safe, compliant, and high-quality coffee while supporting continuous improvement. Key Responsibilities- Coffee Quality Control Monitor roasted coffee quality for consistency against established standards Verify roast profiles using roast software, production data, and/or any other tools available. Advocate for any resources that are needed. Conduct routine cupping sessions for production verification, roast adjustments, and shelf-life checks Identify and communicate roast deviations, defects, or flavor inconsistencies Assist in setting and maintaining sensory standards and reference samples Support evaluation of green coffee quality and incoming materials Maintain and calibrate quality tools and equipment (Agtron, scales, moisture meters, etc.) Key Responsibilities- Food Safety & Quality Compliance Execute and maintain food safety programs including GMPs, sanitation checks, allergen controls, and pest control coordination Perform routine quality and food safety inspections on the production floor Complete and review required QA documentation and logs accurately and on time Support HACCP or Preventive Controls programs (monitoring, verification, recordkeeping) Assist with traceability exercises, mock recalls, and corrective actions Support third-party audits and customer audits through documentation and floor readiness Investigate quality issues, deviations, or customer complaints and assist with root cause analysis Process Support & Continuous Improvement Follow and help maintain SOPs for roasting, packaging, and QC activities Partner with production teams to troubleshoot quality issues in real time Track and report quality metrics and trends Support new product introductions from a quality and food safety perspective Escalate issues appropriately while proposing practical solutions Willingness to work early mornings or adjusted schedules aligned with production Works in conjunction with Corporate Quality Assurance on developing and implementing Standard Operating Procedures, Standard Sanitation Operating Procedures, Hazard Analysis Critical Control Point, and food defense plans. Review, implement, and train on SOP's, SSOP's, HACCP and food defense plans. Coordinate and ensure completion of Corrective Action Preventative Action Plans (CAPA) for all regulatory, third party, internal, and corporate audits. Serve as recall coordinator and coordinate details of recalls, withdrawals, and holds with Corporate QA and the distribution centers. Performs other related duties as assigned. Physical & Work Environment Requirements Ability to work on the production floor for extended periods Ability to lift up to 50lbs Willingness to work early mornings or adjusted schedules aligned with production EEO Statement Performance Food Group and/or its subsidiaries (individually or collectively, the "Company") provides equal employment opportunity (EEO) to all applicants and employees, regardless of race, color, national origin, sex, marital status, pregnancy, sexual orientation, gender identity, religion, age, disability, genetic information, veteran status, and any other characteristic protected by applicable local, state and federal laws and regulations. Please click on the following links to review: (1) our EEO Policy; (2) the "EEO is the Law" poster and supplement; and (3) the Pay Transparency Policy Statement. Required Qualifications Associates/2-year technical 1 - 3 Years Experience working with food safety or implementing food safety programs Coffee roasting or production experience Proficient with all Microsoft Office Suites Ability to work independently, with minimal supervision, and manage projects with many moving parts Excellent communication skills to effectively communicate with staff and business relations. Highly organized, detail oriented and capable of multi-tasking. Critical thinker who uses logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems. Preferred Qualifications Bachelor's Degree Experience working with food safety or implementing food safety Coffee roasting or production experience Familiarity with roasting profiling software (Cropster, Artisan, or similar) Experience with basic quality instruments (Agtron, Moisture meters) programs Proficient with all Microsoft Office Suites Ability to work independently, with minimal supervision, and manage projects with many moving parts Excellent communication skills to effectively communicate with staff and business relations. Highly organized, detail oriented and capable of multi-tasking. Critical thinker who uses logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems.

Posted 3 days ago

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Cybersecurity Program Strategist - IAM Tester / QA Lead

Truist BankRaleigh, North Carolina
The position is described below. If you want to apply, click the Apply Now button at the top or bottom of this page. After you click Apply Now and complete your application, you'll be invited to create a profile, which will let you see your application status and any communications. If you already have a profile with us, you can log in to check status. Need Help? If you have a disability and need assistance with the application, you can request a reasonable accommodation. Send an email to Accessibility (accommodation requests only; other inquiries won't receive a response). Regular or Temporary: Regular Language Fluency: English (Required) Work Shift: 1st shift (United States of America) Please review the following job description: The IAM Lead Tester / QA Lead works closely with key stakeholders—including senior leaders, product owners, engineers, and line‑of‑business partners—to clearly define the testing vision, quality strategy, and overall approach needed to ensure products meet business requirements, mitigate risks, and deliver a high‑quality customer experience. This role collaborates across teams to drive testing initiatives from planning through execution, continuously enhance QA standards and processes, integrate scalable and automated testing solutions, and maintain the strategic direction of the organization’s quality engineering practices. This role will be full-time, onsite (5 days a week) at Truist core location (NC, GA, VA) Essential Duties and Responsibilities Following is a summary of the essential functions for this job. Other duties may be performed, both major and minor, which are not mentioned below. Specific activities may change from time to time. Partner with IAM leadership and IAM cross‑functional teams to define the QA strategy, testing roadmap, and quality objectives for programs and releases. Lead the planning, coordination, and execution of end‑to‑end testing activities—including functional testing, regression, system integration, UAT, performance testing, and automation coverage of entire IAM stack. Oversee IAM test governance and provide clear communication on testing progress, risks, defects, quality metrics, and release readiness. Provide strategic direction on test tooling, automation frameworks, quality standards, and continuous improvement initiatives. Prioritize QA investments and resource allocation to ensure effective coverage and timely delivery across multiple projects. Manage a portfolio of testing activities and lead the delivery of quality controls, including defect prevention, risk‑based test planning, and remediation strategies. Guide teams in identifying gaps, exposures, and areas for improvement within the QA lifecycle, and ensure remediation actions are executed effectively. Mentor testers and QA engineers, fostering a culture of quality, accountability, and technical excellence. Qualifications Required Qualifications: The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Bachelor's degree in business administration, technology related field or equivalent education and related training More than seven years of demonstrated progressive experience in Cybersecurity, with emphasis on data lost prevention, vulnerability management, access management, firewalls, security awareness training, etc. Excellent ability to express complex multi-disciplinary technical and business concepts in terms that are understandable to all levels of Lines of Business and corporate management both verbally and in writing Strong working knowledge of cybersecurity terms, concepts, disciplines, frameworks, best practices and industry/regulatory requirements Preferred Qualifications: 5+ years relevant experience testing SailPoint ISC or other IAM tools like SailPoint IIQ,OIM, Saviynt including lifecycle events, provisioning workflows, access certifications, and policy enforcement. Strong understanding of Identity and Access Management (IAM) concepts such as RBAC, ABAC, least privilege, separation of duties (SoD), entitlements, and identity governance best practices. Experience automating test cases Experience conducting, preparing and presenting analysis, findings and recommendations Cyber security certifications such a CISA, CISSP This role will be full-time, onsite (5 days a week) at Truist core location (NC, GA, VA) Other Job Requirements / Working Conditions Sitting Constantly (More than 50% of the time) Visual / Audio / Speaking Able to access and interpret client information received from the computer and able to hear and speak with individuals in person and on the phone. Manual Dexterity / Keyboarding Able to work standard office equipment, including PC keyboard and mouse, copy/fax machines, and printers. Availability Able to work all hours scheduled, including overtime as directed by manager/supervisor and required by business need . Travel Minimal and up to 10% General Description of Available Benefits for Eligible Employees of Truist Financial Corporation: All regular teammates (not temporary or contingent workers) working 20 hours or more per week are eligible for benefits, though eligibility for specific benefits may be determined by the division of Truist offering the position. Truist offers medical, dental, vision, life insurance, disability, accidental death and dismemberment, tax-preferred savings accounts, and a 401k plan to teammates. Teammates also receive no less than 10 days of vacation (prorated based on date of hire and by full-time or part-time status) during their first year of employment, along with 10 sick days (also prorated), and paid holidays. For more details on Truist’s generous benefit plans, please visit our Benefits site . Depending on the position and division, this job may also be eligible for Truist’s defined benefit pension plan, restricted stock units, and/or a deferred compensation plan. As you advance through the hiring process, you will also learn more about the specific benefits available for any non-temporary position for which you apply, based on full-time or part-time status, position, and division of work. Truist is an Equal Opportunity Employer that does not discriminate on the basis of race, gender, color, religion, citizenship or national origin, age, sexual orientation, gender identity, disability, veteran status, or other classification protected by law. Truist is a Drug Free Workplace. EEO is the Law E-Verify IER Right to Work

Posted today

Kubra logo

Senior QA Engineer (Cypress Automation)

KubraTempe, Arizona
Are you passionate about ensuring software works flawlessly and delivers an exceptional user experience? At KUBRA , we’re looking for a Senior Quality Assurance Engineer to join our growing engineering team and champion quality across our platforms. In this role, you’ll be a key player in validating the performance, reliability, and scalability of products that serve millions of users across North America. From front-end web and mobile applications to back-end API testing , you’ll design and execute comprehensive test strategies, build and maintain automated frameworks, and collaborate closely with Product and Engineering teams to make sure every release meets the highest standards. If you thrive in a dynamic environment, love solving complex technical challenges, and have a passion for doing things the right way, we’d love to hear from you. This is a hybrid role in Tempe, AZ. How You’ll Contribute Serve as the QA champion on assigned projects, ensuring quality standards are met across web, mobile, and API solutions. Design and execute a variety of tests (functional, regression, performance, end-to-end, etc.) and deliver clear, timely results. Develop and maintain automated test cases for new and existing features to improve speed and accuracy. Collaborate with Product and Engineering teams to analyze requirements, create test strategies, and validate business needs. Document defects, track resolutions, and provide metrics to support continuous improvement. Support troubleshooting of production issues and assist in knowledge transfer to internal teams. Strengths That Shine in This Role Bachelor’s degree or diploma in Computer Science , a related field, or equivalent hands-on experience. 5–7 years of experience in a Quality Assurance role, with a strong background in software testing. Proficiency with Linux, Unix, and Windows operating systems . Hands-on experience with Cypress for automated testing (required). Ability to develop automated tests in Java or JavaScript , with knowledge of shell scripting languages (e.g., Bash, PowerShell ). Experience working with source control systems (e.g., Git). Strong understanding of web services testing and familiarity with databases such as SQL, Oracle, MySQL, or DynamoDB. Solid experience testing web applications across multiple browsers and mobile applications on both Android and iOS. Familiarity with specialized testing areas including Accessibility, Security, Performance, and Automation . Bonus: Prior mobile application testing or software development experience is considered an asset. Skills That Matter in This Role Strong knowledge of software testing methodologies, SDLC processes, and QA best practices . Solid understanding of programming concepts and test automation fundamentals . Proven ability to troubleshoot and diagnose complex system issues . Proficient with issue tracking tools such as JIRA. Skilled in creating effective test cases with or without detailed business requirements . Excellent problem-solving skills , with curiosity and persistence to uncover root causes. Highly organized with strong time and project management abilities; capable of managing multiple priorities in a fast-paced environment. Strong oral and written communication skills , able to collaborate across all levels of the organization. Flexible, adaptable, and energized by working in a dynamic environment . Passionate about Quality Assurance , with a commitment to accuracy, precision, and continuous improvement. Why You’ll Love Working Here Thrive in an award-winning, innovation-driven culture that champions growth, embraces diversity, and fosters inclusion for all. See our awards → Earn competitive pay with annual performance-based bonuses that recognize your impact Invest in your future with our 401(k) plan featuring company matching Stay healthy with comprehensive medical, dental, and vision coverage , plus HSA and FSA options Recharge with paid vacation and sick days — and a paid day off for your birthday Make an impact with two paid volunteer days to give back to your community Advance your skills with free access to LinkedIn Learning and our education reimbursement program Prioritize your mental health with a free premium Headspace membership Stay active with our on-site fitness center (Tempe office only) Refuel at fully stocked refreshment stations with complimentary drinks and snacks Enjoy exclusive perks with access to “Tickets at Work” discounts and memberships KUBRA is an equal opportunity employer dedicated to building an inclusive and diverse workforce. We will provide accommodations during the recruitment process upon request by emailing [email protected] . Information received relating to accommodation will be addressed confidentially. We thank all applicants for their interest; however, only candidates under consideration will be contacted. #LI-AA1 #GTA2025 While we value the skills and experiences listed in our job requirements, we also recognize that talent comes in many forms, and welcome applications from candidates who meet most but not all specified requirements. If you possess a strong desire to learn and grow in a dynamic work environment, apply now! KUBRA is a fast-growing company that delivers customer communications solutions to some of the largest utility, insurance, and government entities across North America. KUBRA offers billing and payments, mapping, mobile apps, proactive communications, and artificial intelligence solutions for customers. With more than 1.5 billion customer interactions annually, KUBRA services reach over 40% of households in the U.S. and Canada. KUBRA is an operating subsidiary of Hearst. Our office is small enough to allow creative individuals to flourish, yet large enough to provide long-term stability. We place a tremendous amount of responsibility on our team members to be productive, focused and self-motivated. We offer a casual work environment, competitive compensation and a stellar benefits program. KUBRA does not typically provide immigration-related assistance, including employment-based work visa (e.g. H-1B) sponsorship, work permit applications and extensions, permanent residence (green card) sponsorship, LMIA applications or permanent residency nominations. Candidates must ensure they have legal authorization to work in the U.S/ Canada. All sponsorship determinations are case by case based on business need.

Posted today

Johnson & Johnson logo

QA Associate III

Johnson & JohnsonMalvern, Pennsylvania
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com Job Function: Quality Job Sub Function: Quality Assurance Job Category: Professional All Job Posting Locations: Malvern, Pennsylvania, United States of America, Spring House, Pennsylvania, United States of America Job Description: We are searching for the best talent for a QA Associate III to be based in Malvern, PA with occasional travel to Spring House, PA. Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innov ative-medicine Purpose: On this team, we provide end to end quality oversight of GMP R&D GxP laboratories responsible for analytical testing of commercial and clinical products in the biotherapeutics product portfolio. You will act as a liaison with other internal quality organizations to standardize policies, practices and procedures to increase quality and compliance and champion increased awareness of quality related concerns. You will be responsible for: Partner with Research & Development and Supply Chain teams to support platform analytical method qualification, validation, and transfer to facilitate analysis of pre-clinical, clinical, and commercial products. Collaborate with business partners to support process development studies. Perform regularly scheduled oversight of R&D GxP laboratories. Review and approve raw material and critical reagent release for use across the Janssen global network. Review and approve controlled documents including standard operating procedures, work instructions, validation protocols and reports, and technical studies. Ensure all non-conformances are fully investigated and effective corrective/preventive actions are implemented in a timely manner. Support change management processes including formal change controls by evaluating the proposed changes, assessing impact, and providing quality input on implementation plans. Provide quality oversight of the analytical instrument lifecycle management process, including new instrument qualification, equipment releases, corrective and preventative maintenance and calibrations. Ensure data integrity and maintain compliance with general laboratory operations, all appropriate SOPs for laboratory work, data recording, and laboratory equipment Lead in process improvement activities including assessing current processes, providing improvement input and working with partners to implement changes. Support site inspections and inspection readiness activities. Ensure the laboratories are audit ready. Support data integrity efforts. Other duties may be assigned as necessary. Qualifications/Requirements: A minimum of a Bachelor’s Degree is required, preferably in Engineering, Biology, Biochemistry, Microbiology, Chemistry, or relevant scientific field/equivalent technical field. At least 4 years of experience in a regulated manufacturing environment, preferably in biotechnology or pharmaceutical industry, is required. Ability to maintain written records of work performed in paper-based and computerized quality systems. Ability to work independently on complex issues with minimal supervision. Ability to be organized and capable of working in a team environment with a positive demeanor. A high degree of accuracy and attention to detail, and excellent interpersonal, oral and written communication skills. Solid Understanding of cGMP regulations and FDA/EU guidance related to biologics or advanced therapies is required. Experience in automated laboratory systems and warehouse/raw material sampling and receipt preferred. Experience with quality support in clinical/GMP manufacturing or support of GXP laboratories is preferred. Working knowledge of GLP regulations preferred. Experience working with CMMS Systems like SAP and Maximo, and electronic laboratory notebook systems (Biovia, eLIMS) is preferred. Experience performing and leading quality risk assessments for business processes is preferred. Experience with document reviews and regulatory inspection processes is preferred. Ability to prioritize daily business needs while being flexible and adaptable to frequently shifting priorities. Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource. Required Skills: Preferred Skills: Business Alignment, Business Behavior, Coaching, Compliance Management, Continuous Improvement, Data Analysis, Detail-Oriented, Goal Attainment, Human-Centered Design, Internal Controls, Issue Escalation, Problem Solving, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards

Posted today

hims & hers logo

QA Investigations Specialist

hims & hersGilbert, AZ
Hims & Hers is the leading health and wellness platform, on a mission to help the world feel great through the power of better health. We are redefining healthcare by putting the customer first and delivering access to care that is affordable, accessible, and personal, from diagnosis to treatment to delivery. No two people are the same, so we provide access to personalized care designed for results. By normalizing health & wellness challenges and innovating on their solutions, we're making better health outcomes easier to achieve. Hims & Hers is a public company, traded on the NYSE under the ticker symbol "HIMS." To learn more about the brand and offerings, you can visit hims.com/about and hims.com/how-it-works . For information on the company's outstanding benefits, culture, and its talent-first flexible/remote work approach, see below and visit www.hims.com/careers-professionals. About the Role: The Investigations Specialist is responsible for leading and supporting investigations into quality-related events within both 503A and 503B compounding pharmacy operations. This role collaborates with Quality Assurance (QA), Quality Control (QC), and Quality Systems to ensure thorough root cause analysis, documentation, and resolution of deviations, nonconformances, out-of-specification (OOS) results, and other quality events. The position ensures that investigations are conducted in compliance with applicable regulatory requirements, including USP , , , FDA 503B guidance, and cGMP standards. Key Responsibilities: Event Investigation & Root Cause Analysis Lead, document, and coordinate investigations of deviations, nonconformances, complaints, OOS, and other quality events. Perform structured root cause analyses to determine true causes. Ensure timely initiation, progress, and closure of investigations within defined quality system timelines. Collaborate with production, QC laboratory, and QA to gather evidence and assess event impact. Corrective and Preventive Actions (CAPA) Identify and recommend appropriate CAPAs to prevent recurrence of issues. Ensure CAPA actions are practical, risk-based, and aligned with regulatory and company standards. Track CAPA implementation and verify effectiveness. Compliance & Documentation Prepare clear, accurate, and compliant investigation reports in accordance with internal SOPs and regulatory requirements. Maintain complete records to support regulatory inspections and internal audits. Escalate critical issues to Quality leadership in a timely manner. Cross-Functional Collaboration Work closely with QA, QC, and Quality Systems to ensure consistent application of investigation procedures. Facilitate communication between operations, technical teams, and quality groups during investigations. Participate in site-level quality review boards or investigation review committees. Continuous Improvement Identify trends across investigations and recommend systemic improvements. Support training of staff on deviation reporting, investigation practices, and documentation standards. Contribute to enhancement of site procedures for deviation and OOS management. Qualifications: Education & Experience Bachelor's degree preferred in a relevant discipline (science, quality, or engineering-related field) or equivalent combination of education and experience. 3+ years of related experience in quality, manufacturing, or a regulated industry may substitute for a degree. Knowledge & Skills Bachelor's degree preferred in a relevant discipline (science, quality, or engineering-related field) or equivalent combination of education and experience. 3+ years of related experience in quality, manufacturing, or a regulated industry may substitute for a degree. Strong understanding of USP , , standards, FDA 21 CFR Parts 210 & 211, and cGMP. GDP and GLP practices preferred. Excellent attention to detail, documentation practices, and organizational skills. Experience with investigations, deviation management, and escalation procedures. Proficiency in Google Workspace and familiarity with quality systems software. Strong interpersonal and communication skills (written and verbal). Pharmacy Technician or trainee license or willingness to acquire. Excellent written communication and technical writing skills. Strong collaboration skills across multidisciplinary teams. Ability to manage multiple investigations under tight timelines. Proficiency in electronic quality systems (e.g., TrackWise, MasterControl) preferred. Key Competencies: Analytical and detail-oriented mindset. Strong problem-solving and decision-making abilities. Clear and professional communication skills. High sense of accountability and ownership. Ability to work independently and in cross-functional teams. Our Benefits (there are more but here are some highlights): Competitive salary & equity compensation for full-time roles Unlimited PTO, company holidays, and quarterly mental health days Comprehensive health benefits including medical, dental & vision, and parental leave Employee Stock Purchase Program (ESPP) 401k benefits with employer matching contribution Offsite team retreats We are committed to building a workforce that reflects diverse perspectives and prioritizes ethics, wellness, and a strong sense of belonging. If you're excited about this role, we encourage you to apply-even if you're not sure if your background or experience is a perfect match. Hims considers all qualified applicants for employment, including applicants with arrest or conviction records, in accordance with the San Francisco Fair Chance Ordinance, the Los Angeles County Fair Chance Ordinance, the California Fair Chance Act, and any similar state or local fair chance laws. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Hims & Hers is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans in our job application procedures. If you need assistance or an accommodation due to a disability, please contact us at accommodations@forhims.com and describe the needed accommodation. Your privacy is important to us, and any information you share will only be used for the legitimate purpose of considering your request for accommodation. Hims & Hers gives consideration to all qualified applicants without regard to any protected status, including disability. Please do not send resumes to this email address. To learn more about how we collect, use, retain, and disclose Personal Information, please visit our Global Candidate Privacy Statement.

Posted 30+ days ago

Finastra logo

Senior QA Engineer

FinastraManila, AR
Who are we? At Finastra, we're a global leader in financial services software, dedicated to expanding access to financial services and shaping what's next for the industry. Our technology powers mission‑critical solutions across Lending, Payments and Universal Banking, supporting over 7,000 customers, including 80% of the world's top 50 banks, in more than 110 countries. What will you contribute? Reporting to the QA Lead, the Senior QA Engineer creates and executes product test plans to ensure software products meet design specifications and product quality standards. Assists Development team with process improvements to improve product quality. Responsibilities & Deliverables: Your deliverables as a Senior QA Engineer will include, but are not limited to, the following: Create test cases from product specifications. Automate and Executes test plans and test cases and compiles results. Sets up and maintains personal testing environments. May set up team testing environments. Assist in the review of software development processes to improve product quality. Tracks defects from detection to resolution and works with developers to reproduce and resolve defects. Communicates with stakeholders on product issues. Acquires and maintains knowledge of existing products, operations or systems. Reviews product documentation to ensure completeness and accuracy. Provides support to stakeholders prior to GA release of software. Create and/or run SQL scripts to populate data and validate test results. Design, develop, and maintain test scripts to be automated. Provide testing effort estimates for enhancements. Required Experience: 5+ years' experience in software testing or related field. Experience in the software or financial industry preferred. Experience with relational databases preferred. Proficiency with Microsoft Office including Co-Pilot applications. Effective verbal and written communication skills; effective customer service skills. Ability to work independently or within a team environment and handle multiple projects simultaneously. Knowledge of quality assurance methods and techniques including the software development lifecycle. Effective planning and organizational skills, with an attention to detail. Effective analytical and problem-solving skills and ability to think 'out of the box' for process improvements. Ability to work with specialized software tools; effectively implement and evaluate new processes or plans. Ability to execute test plans and test scripts for commercial software applications, document expected results vs. actual results, and record software defects. Preferred knowledge of automated testing software tools with ability to design and develop automated testing programs. Preferred knowledge of the Agile software development methodology. Experience in Python/Robot scripting an advantage. Must be a Bachelor's Degree graduate. We are proud to offer a range of incentives to our employees worldwide. These benefits are available to everyone, regardless of grade, and reflect the values we uphold: Flexibility: Enjoy unlimited vacation, based on your location and business priorities. Hybrid working arrangements, and inclusive policies such as paid time off for voting, bereavement, and sick leave. Well-being: Access Confidential one-on-one therapy through our Employee Assistance Program, find support from our network of Wellbeing Champions and Gather Groups, and a calendar of monthly events and initiatives designed to help you thrive - Inside and Outside of work. Medical, life & disability insurance, retirement plan, lifestyle and other benefits* Sustainability: Benefit from paid time off for volunteering and donation matching. DEI: Participate in multiple DE&I groups for open involvement (e.g., Count Me In, Culture@Finastra, Proud@Finastra, Disabilities@Finastra, Women@Finastra). Career Development: Access online learning and accredited courses through our Skills & Career Navigator tool. Recognition: Be part of our global recognition program, Finastra Celebrates, and contribute to regular employee surveys to help shape Finastra and foster a culture where everyone is engaged and empowered to perform at their best. Specific benefits may vary by location. At Finastra, each individual is unique, bringing their own ideas, thoughts, cultural beliefs, backgrounds, and experiences together. We learn from one another, embrace and celebrate our differences, and create an environment where everyone feels safe to be themselves. Be unique, be exceptional, and help us make a difference at Finastra!

Posted 2 days ago

L logo

QA Internship

Lucid Software Inc.Raleigh, NC
Lucid Software is the leader in visual collaboration and work acceleration, helping teams see and build the future by turning ideas into reality. Our products, business, and workplace culture have received numerous awards, such as being named to the Forbes Cloud 100 and a Fortune Best Workplace in Technology. This position is hybrid, combining remote work with in-person collaboration at our Raleigh, NC office two days per week (Tuesday and Thursday). At Lucid, we hold true to our core values of teamwork over ego, innovation in everything we do, individual empowerment, initiative, and ownership, and passion and excellence in every area. We value diverse perspectives and are dedicated to creating an environment that is respectful and inclusive for everyone. We are seeking a QA Intern to join our team from April - August 2026. As a QA Intern, you'll support the delivery of new features and fixes across our product line while gaining hands-on experience in a real-world development environment. You'll be a fully integrated member of a scrum team, working closely with Software Engineers, Product Managers, and User Experience Designers to help ensure high-quality releases, while also having the support of the broader QA team whenever additional collaboration or troubleshooting help is needed. Our team prioritizes hands-on testing over heavy documentation, allowing us to move quickly and stay focused, and this role offers meaningful autonomy-making a proactive, self-starter mindset essential. Your day-to-day work will include participating in stand-up meetings, reviewing pull requests, and testing new functionality using multiple strategies, along with regular 1:1 meetings with your manager to discuss current priorities, growth areas, and long-term career goals. Do you enjoy brainstorming and exploring ideas from multiple perspectives, have a strong attention to detail, and tend to notice issues others may overlook? Are you comfortable identifying ambiguity and asking thoughtful clarifying questions, enjoy troubleshooting and problem-solving, and are curious about learning everything a piece of software can do? Above all, are you passionate about creating a positive, intuitive experience for the people who use the product? If so, this role is for you! Responsibilities: Holistically considers and advocates for quality in how scrum teams build and maintain our software Consider various use cases and apply those to testing new features and bug fixes Use manual testing to mimic the way users would interact with our software Work with the entire QA team to complete testing for larger initiatives like new product launches Collaborate with product management, design, and development teams on the quality of the user interface, functionality, and specifications of new features Attend all meetings with your development team and enable all to be quality advocates Help maintain team's bug backlog, prioritizes bugs, helps drive them to completion Apply critical thinking to identify areas for improvement with our software and QA practices Finds ways to identify and mitigate the risk of releasing new features and updates Requirements: Ability to be organized, detail-oriented, and thorough Strong curiosity, creativity and tenacity toward imagining use cases and software functionality Passionate about quality and empathetic toward the user experience Can easily thrive working in an evolving industry Ability to work well with and communicate with others Prefers working on a collaborative team to achieve common goals Bias towards finding solutions instead of just identifying problems Can relate to Lucid Software's products and core values Strong display of ownership and a desire to grow in career 0-3 years of experience Preferred Qualifications: Experience with Jira and Confluence Genuine enjoyment of software quality assurance work Desire to be on a highly productive, fast-paced team Experience with web application testing Experience with development and execution of test suites #LI-DA1

Posted 4 days ago

First Financial Bankshares logo

Suspicious Activity Report QA Officer

First Financial BanksharesAbilene, TX
Address We're always looking for bright individuals to join our growing organization. As a part of the First Financial Family, we will invest in your development and provide a dynamic work environment where you're challenged, valued and empowered every day. We strive to be the best destination for the industry's top talent, creating a diverse, collaborative workplace that celebrates innovation and change. We are one team, working together to get things done. Job Description: OFFICE LOCATION: Abilene, Texas, United States SCOPE/CONTACTS: The Suspicious Activity Report (SAR) Quality Assurance (QA) Officer is responsible for reviewing, validating, and ensuring the accuracy and completeness of SARs filed by the bank and trust company. This role ensures compliance with regulatory requirements, internal policies, and industry standards to mitigate financial crime risks and maintain strong relationships with regulatory bodies. ESSENTIAL FUNCTIONS: Conduct quality assurance reviews of SARs to ensure accuracy, completeness, and timeliness. Verify that SAR narratives clearly articulate suspicious activity and meet regulatory expectations. Collaborate with investigators and analysts to resolve discrepancies and improve SAR quality. Maintain documentation of QA findings and provide feedback to enhance the SAR investigation and preparation processes. Monitor regulatory changes and update QA procedures accordingly. Assist in preparing reports for senior management, regulatory examinations, and audits. Ensure confidentiality and secure handling of sensitive information. Compile compliance training related to the position in a timely manner. Understand and comply with applicable laws and regulations that apply to SAR reporting. Comply with the bank's Code of Business Conduct and Ethics and Information Security policies. Perform other duties and special projects, as assigned. Actively participate in the service culture, support the values of the organization, and follow established Bank policies and procedures. MINIMUM QUALIFICATIONS: Three (3) to five (5) years of financial institution-related or government reporting experience required. Good proficiency with technology such as PCs and software/web-based products. High proficiency in Microsoft Suite of products, especially Word and Excel. High degree of self-motivation and ability to work autonomously. Excellent written and verbal communication skills and ability to interact well with internal and external stakeholders. PREFERRED SKILLS: Bachelor's Degree preferred. Risk-related certification(s), such as Certified Anti-money Laundering Specialist (CAMS) or ABA Certified AML and Fraud Professional (CAFP) is preferred, but not required The above statements reflect the general details considered necessary to decide the principal functions of the job identified and shall not be construed as a detailed description of all work requirements that may be inherent in the job. Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)

Posted 30+ days ago

N logo

Sr. Clinical QA Manager

Neurocrine Biosciences Inc.San Diego, CA

$148,500 - $203,000 / year

Who We Are: At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering for people with great needs. What We Do: Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, endometriosis and uterine fibroids, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X and Facebook. (*in collaboration with AbbVie) About the Role: Responsible for driving and leading Clinical Quality Assurance (CQA) activities in support of research projects across multiple therapeutic areas for development and commercial products. Provides Quality Assurance ("QA") expertise, leadership and training to ensure adherence with applicable regulatory requirements and company policies/procedures. _ Your Contributions (include, but are not limited to): Primary Function Study Team Support: Serve as the CQA Lead for complex programs, including those requiring unblinded CQA roles Develop risk mitigation plans and strategies Monitor the regulatory status of clinical investigators as well as study/site/vendor issues for GCP risks and take action when necessary Provide guidance on remediation and corrective action plans to ensure all parts of the study are conducted properly and in compliance Lead site inspection preparation activities and review inspection findings and responses in conjunction with QA management Provide GCP training as needed, including Investigator Meeting training Quality Systems Work with (may lead) a multidisciplinary team to standardize clinical development activities within and across programs through preparation of SOPs and personnel training Proactively research, test and implement quality systems, processes and procedures within CQA area Develop and assess GCP metrics, conduct trend analyses of GCP quality system metrics (e.g., audit observations, deviations, CAPAs, GCP QA activities) for management reporting. Proactively identify areas for improvement and collaborate with QA and GCP departments on continuous improvement initiatives QA Department Support Partner with QA management to drive strategies to ensure compliance to regulations, guidelines and company SOPs across the organization, and lead QA initiatives as assigned Support all on-site regulatory inspection activities May work on other projects within QA not related to GCP Secondary Functions Good Clinical Practice ("GCP") Audit Management: Lead, plan, conduct, and oversee GCP audits (e.g., vendor, clinical investigator site, internal audits) to ensure compliance with applicable GCP/regulatory requirements and guidelines, study protocols, monitoring plans and applicable policies/procedures Develop and lead the execution of audit plans for assigned programs in line with overall QA annual audit plans, including audit resourcing, oversight of consultant auditors, and communications to internal and external stakeholders as applicable. Assist in the audit site selection process for study-specific audit plans. Ensure timely audit conduct, reporting, review, and closeout in accordance with Company SOPs Maintain current and accurate audit records, including CQA audit schedules, files, and audit database/tracker Provide proactive audit status and metrics reports to management Other duties as assigned Requirements: BA/BS in life sciences or related discipline or RN and 8+ years of related industry experience, including 4 years in CQA in drug development environment is preferred. Proven track record and experience in searching, review and implementation of regulatory requirements and guidelines OR Master's degree in life sciences or related discipline and 6+ years of similar experience noted above Expert knowledge of all Clinical Trial related FDA regulations and ICH Guidelines, and experience with international GCP regulations and guidelines is desired. Experience with gene therapy clinical trials is preferred Demonstrated ability to create a comprehensive audit program and carry out audits of investigator sites and clinical research vendors for Phase I-IV studies. Requires an in-depth knowledge of auditing principles, techniques and communication skills to clearly and efficiently convey findings and report deficiencies to auditees as well as the Company's management Ability to identify and escalate problems and follow-through with the corrective actions Ability to work closely with both internal and external personnel to increase the level of compliance and cooperation while creating opportunities to improve operations and effective implementation to reduce errors Anticipates business and industry issues; recommends relevant process improvements Demonstrates broad expertise or unique knowledge Considered an expert within the company and may have external presence in area of expertise Applies in-depth expertise in discipline and broad knowledge of other closely related areas to improve efficiency of team Ability to work as part of and lead multiple teams Good leadership, mentoring skills and abilities typically leads lower levels and/or indirect teams Excellent computer skills Excellent communication, problem-solving, analytical thinking skills Sees broader picture and longer-term impact on division/company Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency Excellent project management, strong project leadership skills #LI-SA1 Neurocrine Biosciences is an EEO/Disability/Vets employer. We are committed to building a workplace of belonging, respect, and empowerment, and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don't line up to exactly what we have outlined in the job description. _ The annual base salary we reasonably expect to pay is $148,500.00-$203,000.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 30% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.

Posted 30+ days ago

C logo

JR QA Hardware Engineer

Clear BallotNashua, NH

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Overview

Schedule
Full-time
Education
Engineering (PE)
Career level
Entry-level
Benefits
Career Development

Job Description

We are looking for a motivated Junior Hardware Quality Engineer to join our Hardware Engineering team.

This position serves as the designated entry point for recent university graduates or early-career engineers

looking to launch a career in hardware development and testing.

In this role, you will translate your academic knowledge into practical engineering skills under the close

guidance and mentorship of senior team members. You will learn and gain hands-on experience in the

hardware development of voting systems, from the initial design phase through prototyping and production

readiness. Your responsibilities will include assisting with prototype testing, supporting internal validation

efforts, and overseeing testing performed by external laboratories as part of formal certification processes.

Throughout this role, you will also develop foundational knowledge of the Voluntary Voting System

Guidelines (VVSG)-the federal standards that ensure voting systems are secure, reliable, and

accessible-as well as the hardware testing requirements necessary to meet certification and regulatory

compliance.

What You'll Do

● Lab Operations & Hardware Management: You will be responsible for installing software on lab

hardware, inspecting incoming electronic parts, managing lab inventory, and preparing hardware for

demonstrations.

● Defect Reporting: You will log defects, report test results, and communicate findings clearly and

promptly to senior team members.

● Root Cause Analysis Support: You will assist in reproducing hardware issues to support Root Cause

Analysis (RCA) efforts and gather necessary information to aid in drafting Product Requirements

Documents (PRDs).

● External Testing Opportunities: You will have the unique opportunity to shadow and oversee EMI/EMC

and environmental testing at external laboratories to gain hands-on experience with regulatory

certification processes.

Qualifications

Education: Bachelor's degree in Electrical Engineering, Mechanical Engineering, or a related technical

field.

● Experience: 0-2 years of relevant experience.

● Technical Aptitude: A strong desire to learn voting system hardware and drive quality through

hands-on engineering. You must possess a natural aptitude for breaking and taking things apart in a

structured way to identify weaknesses.

● Test Instrumentation Proficiency: Hands-on experience with standard lab equipment, including

oscilloscopes, digital multimeters (DMMs), and desktop power supplies.

● Hardware & Software Setup: Familiarity with installing drivers, OS, and software on hardware.

● Communication: Strong verbal and written communication skills are essential. You must be able to

work effectively with other departments and clearly report test results and technical issues.

● Office Productivity Tools: Proficiency with Microsoft Office and/or Google Workspace applications

(Word/Docs, Excel/Sheets) for documentation and data analysis.

Nice to Have

● Previous Internships: Prior internship experience in hardware engineering or quality assurance.

● CAD & PCB Layout: Familiarity with Computer-Aided Design (CAD) tools and circuit board layout

software is beneficial for understanding and reviewing mechanical and electrical components.

● Soldering & Rework: Experience with soldering and using rework stations, including the ability to

perform basic soldering and rework on printed circuit boards (PCBs) for minor repairs or modifications.

● Schematic Interpretation: Interest in learning to read and interpret electrical schematics and

mechanical drawings to trace signals and identify potential failure points.

● Agile & Tools: Experience working within Agile frameworks (Scrum or Kanban) using Atlassian products

(Jira, Confluence).

● Linux OS: Familiarity with Linux operating systems.

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