landing_page-logo

Auto-apply to these qa jobs

We've scanned millions of jobs. Simply select your favorites, and we can fill out the applications for you.

QA Specialist I/Ii-logo
QA Specialist I/Ii
KBI BiopharmaDurham, NC
At KBI Biopharma, we are advancing science and accelerating breakthroughs. As a global leader in biopharmaceutical development and manufacturing, we empower life science companies to bring new medicines and vaccines to the world faster. Explore your potential at KBI, where innovation meets impact. The Manufacturing Quality Assurance (MQA) Specialist is responsible for supporting the Manufacturing Process and Areas as part of a rapidly expanding GMP Contract Manufacturing Organization. MQA Specialists are expected to provide sound guidance to Manufacturing with respect to process, SISPQ of product, and risk. MQA Specialists share responsibility for the inspection readiness of the site. MQA Specialists routinely work on the cleanroom floor directly with the Manufacturing team to provide real time guidance and support. Specialists routinely collaborate with Manufacturing and work on team initiatives. The MQA Specialist may also be responsible for coaching and mentoring as needed to foster a GMP compliant site. In addition to supporting Manufacturing, MQA Specialists are responsible for the execution of core activities during a 12-hour 2-2-3 schedule, including but not limited to: Executed Batch record review and approval Logbook review and approval Deviation guidance and generation Routine facility walkthroughs Facility response for work compromising clean environment. SOP review Bulk Fill Label reconciliation Alarm response and acknowledgement Support external client review and resolution of comments. Creation and Release of electronic Batch Records, electronic Solution Records, electronic Equipment Preparation Records, etc. in MODA-ES Admin Client MQA Specialist I High School diploma or equivalent. Degree progression preferred. GMP / regulated industry / laboratory experience is required (approximate 1-3 years). Demonstrated ability to work in a team environment. Demonstrated ability to understand the manufacturing process. Ability to perform routine core MQA responsibilities. Review written procedures for accuracy and provide feedback as needed MQA Specialist II Associate degree / Bachelor's degree strongly preferred or appropriate years of experience (approximate 3-6 years). Demonstrated ability to work in a team environment and strong communication skills within all levels of an organization. Demonstrated ability to represent Quality on interdepartmental meetings. Demonstrated knowledge of technical documents. Demonstrated ability to become qualified trainers. Ability to track and trend department metrics. Review written procedures for accuracy and provide feedback as needed Salary Range: MQA Specialist I: $55,000 - $75,900 MQA Specialist II: $63,000 - $86,900 Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidate's qualifications and experience and may be outside this range. KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, 401K matching with 100% vesting in 60 days and employee recognition programs. About KBI: KBI Biopharma, Inc., a JSR Life Sciences company, is a global contract development and manufacturing organization (CDMO) providing fully integrated and accelerated drug development and biologics manufacturing services to life science companies. KBI supports its 500+ customers in advancing more than 160 drug candidates from preclinical and clinical stages to market, including the manufacture of ten commercial products. Recognized for quality manufacturing, KBI delivers robust process development and cGMP manufacturing services across its six global locations in the USA and Europe. For more information, visit www.kbibiopharma.com. KBI is a proud EEO/AA employer dedicated to building a diverse and inclusive workforce. We believe that innovation thrives in an environment where all voices are heard and valued. That's why we actively seek individuals from all backgrounds - regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability, or veteran status - and strongly encourage all qualified candidates to apply and bring their unique perspectives to our team. KBI Biopharma is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must inform KBI Biopharma of their vaccination status and must submit their vaccination status. All vaccinated employees are required to provide proof of their COVID-19 vaccination, with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization. KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply. I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary. I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.

Posted 5 days ago

QA Device - Commissioning And Qualification-logo
QA Device - Commissioning And Qualification
Eli Lilly And CompanyIndianapolis, IN
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. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $63,000 - $162,800 At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism. Delivery Device and Connected Solutions (DDCS) and Indianapolis Device Manufacturing (IDM) leads all aspects of the development, commercialization, manufacture, and global technical stewardship of delivery devices used to administer many of the therapeutics in Lilly's portfolio. The QA Representative - Commissioning and Qualification provides quality oversight and support for medical devices and combination products during technical transfer to contract manufacturing operations. Responsibilities: The quality representative ensures design meets critical requirements and risks to product quality have been identified, addressed in the design and tested. The quality representative will verify that equipment is fit for use and ensure manufacturing readiness for prospective contract manufacturers (CM) and suppliers. Provide quality oversight for the technical transfer of medical devices in the emerging IDM portfolio. Support device development reviews to ensure appropriate design for manufacturability. Conduct manufacturing readiness assessments for prospective contract manufacturers and suppliers to ensure adequacy of the Quality Management System (e.g., facility, staffing, procedures, training, maintenance). Provide quality support/consulting for TS/MS device manufacturing for design verification, molding packages, process validation (component, non-molded component, subassembly, final pen) and change control including equipment modifications. Review/approve GMP documents for CMs process manufacturing including: protocols, technical reports, deviations, change controls, inspection procedures and specifications, sampling plans, sort/rework procedures and validation packages. Support continuous improvement projects. Assist with internal audits and supplier audits and maintain supplier management requirements. Computer system validation activities, serving as CSQA (Computer Systems Qualified Associate) for review and approvals. Provide CM Q support for newly launched products as requested by manager. Apply knowledge of medical device governing standards and regulations (e.g., 21 CFR Part 4, Part 11, Parts 210/211, Part 820, QSR, ISO 13485, ISO 14971, Canadian MDR, EU Medical Device Directive, JPAL) to ensure organizational capability of prospective contract manufacturers and suppliers. Basic Qualifications: 5+ years industry related experience which may include Quality, Technical Services, Product Development, and/or Manufacturing of medical devices preferred Bachelor's Degree in engineering or science related field preferred Additional Skills/Preferences: Experience working with contract manufacturers and suppliers Knowledge of global medical devices and combination product regulations (e.g. 21CFR820, 21CFR Part 4, Part 11, ISO 13485, ISO 11608, Canadian MDR, EU Medical Devices Directive/Regulation, JPAL, TGA, ANVISA) Knowledge of Quality System elements, devices, design, manufacturing, and validation and their application in a manufacturing environment Experience with plastic molding/assembly operations Experience with Microsoft applications, Veeva, TrackWise Effective communication, interpersonal, and networking skill Self-management skills Strong attention to detail Ability to work as part of a team Problem solving skills Meets commitments and deadlines Ability to multi-task meaningful priorities Strong technical writing skills and proficiency in technical review of documents Strong organizational, time management and planning skills Ability to work in a dynamic, highly matrixed and fast paced environment Additional Information: Some US and OUS travel may be required (up to 30%) 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 an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, 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 help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups. 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 30+ days ago

QA Shop Floor Specialist-logo
QA Shop Floor Specialist
SanofiRidgefield, NJ
Job title: QA Shop Floor Specialist Location: Ridgefield, NJ Shift: 10pm to 6am About the Job Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress. Join our Biosurgery Quality Team as a QA Shop Floor Specialist and you'll ensure compliance with cGMP, regulatory, and internal requirements regarding the manufacturing, testing, and distributing of products through formal QA walkthroughs, Audits and Investigations that may result in additional training and recommendations to procedural improvements. Evaluate and provide QA recommendations for all products, systems, facilities, and issues that are affected or may be affected by regulatory or cGMP requirements. Increase quality culture in the manufacturing areas. Enhance technical knowledge of operators and shop floor managers by providing positive and constructive feedback. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started? Main Responsibilities: Conduct QA Shop Floor Walkthrough and Audit based on schedule and assignment Documentation of appropriate findings and support area improvement Support the Lead and Manager to drive QA shop floor program and address concerns with manufacturing and driving quality improvements Mentoring and coaching QA Shopfloor personnel Coaching manufacturing team, when required Collaboration with manufacturing on process improvements Area/Line clearances, when requirerd Review documentation- BPRs, Logbooks Deviation support, when required Perform audits, walk-throughs, GEMBAs, technical coaching Support Lead and Manager with tasks as needed (Change Control, Deviations etc) Support Additional Quality functions (Media Fill Observer, Documentation Updates etc) About You Basic Qualifications/Requirements: Bachelor's Degree in Life Sciences or Engineering with 2-3 years' experience in a cGMP controlled/ pharmaceutical industry with a demonstrable working knowledge of contamination control, aseptic processing, cGMPs and regulatory requirements. Or 3 years or more of relevant experience in a cGMP controlled/ pharmaceutical industry with a demonstrable working knowledge of contamination control, aseptic processing, cGMPs and regulatory requirements in lieu of degree Must have Aseptic Manufacturing and Quality Auditing Experience Has experience with Filling machines in Grade A Worked in a Microbiology laboratory or Aseptic Production/Manufacturing Facility environment Advanced knowledge of MS Office including Excel, PowerPoint, and Word. The shift for this position is from 10pm to 6am. Preferred Qualifications: Packaging experience is preferred Decision making, auditing, and deviation investigations. Demonstrated willingness to learn, teamwork abilities, excellent communication, adaptability, organizational and analytical skills, and a strong interest in the pharmaceutical and bio-pharmaceutical industry. Must have excellent written and verbal communication skills Why Choose Us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SG #LI-GZ #LI-Onsite #vhd Pursue progress, discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! US and Puerto Rico Residents Only Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. North America Applicants Only The salary range for this position is: $57,000.00 - $82,333.33 All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.

Posted 1 week ago

Manager, QA Manufacturing Compliance, Hopewell Site-logo
Manager, QA Manufacturing Compliance, Hopewell Site
Beigene, Ltd. ApacHopewell, VA
BeiGene, Ltd. has proposed to change its name to BeOne Medicines Ltd. The new name is subject to shareholder approval and, once approved, use of the name will be phased in over 2025. There may be instances where "BeiGene" or "BeOne" are used to describe the company during this transition period. BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. General Description: Supports QA investigation activities, ensuring the successful day to day management of: Deviations, root cause analysis, CAPA's, effectiveness checks, internal and external customer complaints, and related support activities. Works to support QA Key Performance Indicators (KPIs) such as SOP mandated cycle times, on time closure dates, and QA objectives, whilst adhering to regulatory compliance and achieving business success. Work to support both internal GMP audits and Health Authority audits. Supports QA Manufacturing related tasks as assigned by QA Management.to ensure the efficient and effective day to day running of the QA Manufacturing Team. Essential Functions of the job: Ensures the development of Manufacturing QA and Compliance SOPs (writing, revising and approving), ensuring regulatory compliance in conjunction with being 'fit for purpose' operationally and commercially. Supports QA manufacturing shop floor activities with resources as needed. Support all QA shop floor and batch systems to ensure compliance with FDA/EU regulations, covering cGMP for commercial medicinal products and clinical material for human use. Significant participation in regulatory and customer inspections/audits. Significant knowledge in GMPs: CFR 210, 211, and 600; knowledgeable in EU Advanced Therapy Medicinal Products (ATMPs). Ensures all activities are performed in accordance with GMPs, SOPs and Health and Safety policies. Maintaining an awareness of new and proposed legislation that impacts the business and communicating any changes to the Senior Management Team. Ensuring that the QA batch release function and Deviation and CAPA processes meet or improve key performance indicators (KPIs). Supervises direct reports, to ensure compliance with business procedures and GMP's Ensuring appropriate investigation of discrepancies, errors, complaints, failures, or adverse events requiring documented review and action. Undertaking any other duties for any department within the business, which may be requested by the QA Department Head, for which training and/or an explanation has been provided and the scope of work is understood. Core Competencies, Knowledge, and Skill Requirements Scientific degree (ideally biotechnology, biology, pharmacy, pharmaceutical sciences, chemistry or related scientific field). Minimum of 5+ years of experience in biological quality assurance, preferably with advanced knowledge of large molecule manufacturing in an FDA-regulated biotechnology or pharmaceutical company with progressive levels of responsibility required. Minimum of 2-5 years of experience in people management, knowledge of cGMP and Data Integrity Guidance utilized in a manufacturing operations environment. Demonstrable track record and skills/experience gained within a similar position(s), at a similar level. Working knowledge of cGMPs: 21CFR parts 2010 & 211, knowledge of 21CFR600 - Biologics desirable. Wide knowledge of products and processes used in the manufacture of unlicensed medicines (clinical materials, mfd. under and IND or IMP). Knowledge of commercial BLA products. Strong personal leadership skills and experience, ability to lead small teams. Good communicator (written and verbal) and strategic thinker, highly customer focused. Strong analytical and problem-solving ability. Strong project management skills. Hands-on approach, with a 'can do' attitude. Ability to prioritize, demonstrating good time management skills. Excellent attention to detail, with the ability to work accurately in a busy and demanding environment. Self-motivated, with the ability to work proactively using own initiative. Committed to learning and development. Highly Desirable: Good IT skills e.g., Microsoft Office (Word, Excel, PowerPoint, Project and Outlook) Significant Contacts Interacts with BeOne employees in all departments; CMOs. Supervisory Responsibilities: Supervises direct reports within the Manufacturing QA and Compliance Team, assists with batch review and release as necessary. QA, Mfg. shop floor QA oversight. Works to ensure that QA Compliance requirements are adequate and meet global standards. Computer Skills: Strong PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint). Ability to work on a computer for extended periods of time Other Qualifications: Ed ucation Required: Bachelor of Science Degree (or above) in a related scientific discipline Must be able to work in the US without corporate sponsorship. Travel: Ability to travel approximately10%; Requires a valid passport. Global Competencies When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world. Fosters Teamwork Provides and Solicits Honest and Actionable Feedback Self-Awareness Acts Inclusively Demonstrates Initiative Entrepreneurial Mindset Continuous Learning Embraces Change Results-Oriented Analytical Thinking/Data Analysis Financial Excellence Communicates with Clarity Salary Range: $104,600.00 - $144,600.00 annually BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeiGene, Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness. We are proud to be an equal opportunity employer and we value diversity. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.

Posted 30+ days ago

Mechanical Document Reviewer (Mep) - QA /QC-logo
Mechanical Document Reviewer (Mep) - QA /QC
Gilbane Building CompanyProvidence, RI
Overview Are you looking for a highly rewarding opportunity that provides extensive career growth opportunity? Gilbane is seeking an IDC Reviewer II to perform all discipline review functions on assigned projects and is responsible for one or more discipline reviews. The IDC Reviewer II has the ability to complete all IDC checklist steps independently for select discipline(s), may mentor team members, and works under the supervision of the IDC Manager or Senior IDC Manager. Who are we? As a Top-10 ENR Contractor, Gilbane is a family-owned business with 45 offices that has been shaping communities since 1870. Consistently recognized as one of the most reputable construction management firms in the country, Gilbane is committed to delivering projects safely and on-time. You will have the opportunity to build schools, labs, hospitals, corporate offices, sports arenas and more! We are dedicated to building a diverse, inclusive and authentic workplace, so if you're excited about this role but your past experience doesn't align perfectly with every qualification in the job description, we encourage you to apply anyway. You may be just the right candidate for this or other roles. Who are you? You are someone who acts inclusively, showing empathy and treating others with respect and dignity in order to uphold Gilbane's core value of Caring and "People First" workplace culture. You seek to listen in order to understand and can convey information clearly. You're a strong problem solver who can identify, prioritize, and implement alternatives for solutions, and you demonstrate adaptability by collaborating with others and supporting team members to achieve excellence. A self-starter who shows passion, commitment, and ownership all while delivering on business outcomes and driving results. You're someone who identifies opportunities for new and improved ways of doing things that result in value-add solutions. Your core values match Gilbane's: Integrity, Caring, Teamwork, Toughmindedness, Dedication to Excellence, Discipline, Loyalty, and Entrepreneurship. What's in it for you? Gilbane offers employees multi-dimensional training opportunities through a number of resources. While managing your responsibilities to projects, you will be able to enroll in trainings through our award-winning Gilbane University to build leadership and technical skills. In addition, you would work with an experienced team which provides you with the opportunity to learn new industry skills every day. You will protect and promote the interests of both Gilbane and the client in all matters as well as demonstrating the personal characteristics of a developing leader. This role offers flexibility in location to accommodate the right candidate. Responsibilities Understands and executes IDC checklist items for specific discipline(s) Creates Coordination Issues in Procore that highlight missing items or items that aren't coordinated Completes all IDC checklist tasks for a specific discipline(s) in a professional manner with minimal direction Contributes to IDC Policies and Procedures Qualifications EXPERIENCE/EDUCATION Bachelor's degree in Architecture or Engineering preferred 3+ years of experience in the construction field, in a design environment, or in a related field Or equivalent combination of education and experience KNOWLEDGE, SKILLS & ABILITIES Ability to read and understand construction documents and specifications Ability to investigate cross discipline coordination issues Strong verbal and written communication skills Strong attention to detail and quality skills Ability to work and partner with others on the IDC team, design partners, and client partners Ability to be self-disciplined and flexible by changing assignments as workload priorities change Knowledge of construction means and methods Knowledge of the following software is preferred but not required: Procore & Bluebeam Strong time management and organization skills Strong computer skills within Microsoft Office Suite and IDC software Salary to be determined by the education, experience, knowledge, skills, and abilities of the applicant, internal equity, and alignment with market data. This salary range for this role is $63,000-$100,100 plus benefits and retirement program. This role offers flexibility in location to accommodate the right candidate. Gilbane offers an excellent total compensation package which includes competitive health and welfare benefits and a generous profit-sharing/401k plan. We invest in our employees' education and have built Gilbane University into a top training organization in the construction industry. Qualified applicants who are offered a position must pass a pre-employment substance abuse test. Gilbane is an Affirmative Action/Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to age, color, national origin, race, religion, sex, sexual orientation, gender identity, protected veteran status, or disability status. Note to Recruiters, Placement Agencies, and Similar Organizations: Gilbane does not accept unsolicited resumes from agencies. Please do not forward unsolicited agency resumes to our jobs alias, website, or to any Gilbane employee. Gilbane will not pay fees to any third party agency or firm and will not be responsible for any agency fees associated with unsolicited resumes. Unsolicited resumes received will be considered property of Gilbane and will be processed accordingly.

Posted 30+ days ago

Senior QA Engineer-logo
Senior QA Engineer
KandjiMiami, FL
About Kandji Kandji is the Apple device management and security platform that empowers secure and productive global work. With Kandji, Apple devices transform themselves into enterprise-ready endpoints, with all the right apps, settings, and security systems in place. Through advanced automation and thoughtful experiences, we're bringing much-needed harmony to the way IT, InfoSec, and Apple device users work today and tomorrow. Some of the smartest money in tech has partnered with Kandji to realize our vision, including Tiger Global, Felicis, Greycroft, First Round Capital, and Okta Ventures. In July 2024, Kandji raised $100 million in capital from General Catalyst, bringing Kandji's valuation to $850 Million. Since Kandji's Series C in 2021, the company has seen a 600%+ increase in annual recurring revenue, and its customer base has grown nearly 4X across 40+ industries. Notable customers include Allbirds, Canva, and Notion, and the company has partnerships with such industry giants as ServiceNow, AWS, and Okta. Kandji was also named to Forbes' Next Billion Dollar Startup List 2023 and recognized as a top venture-backed startup with the potential to reach unicorn status. The Opportunity: Kandji is looking for an experienced Sr. Quality Assurance Test Engineer to join our growing team! As a Sr. QA Test Engineer, you will be embedded on one of our development teams, where you will own all of the manual and automated testing requirements for that product area. We are looking for testers who can exhibit a high degree of ownership, passion, and communication to bring our team to the next level. How you'll make a difference day to day: Manage, drive, and own the entire testing process for your development team Develop, maintain, and execute comprehensive test strategies, test plans, test cases, swarm test sessions, and test procedures Perform function, integration, regression, exploratory, automated and end-to-end testing Reproduce, diagnose, and document software defects with clarity and precision Play a key role in early product development discussions to ideate, review, and catch potential issues before code is written We'd love to hear from you if you have: 4+ years of experience in a software testing role Exceptional knowledge of QA fundamentals and best practices: test strategies, test planning, test execution, defect management, reporting, etc. Excellent time management, organization, communication, and problem-solving skills Exposure to Agile development environments and associated scrum activities, such as planning, grooming, retrospective, etc. Experience with Playwright, Appium, or other automated test frameworks Required to work on-site 5x a week in our Miami office (Coral Gables). Nice to have, but not required: Direct experience testing for growth/onboarding teams 8+ years in a software testing role Experience with issue tracking systems, such as Jira, Rally, Trello, etc. Experience with test case management systems, such as TestRail, qTest, Zephyr, etc. Extensive hands-on experience testing or managing the deployment of devices, software, and services Significant knowledge in the areas of device management and software integration within an enterprise setting, including printers, WiFi, directory services, Kerberos, SSO, etc. Fluency with shell scripting, Python, Typescript and/or the macOS command line Comfortable using terminal to execute commands, run scripts, etc. Extensive knowledge of the MDM space Ability to test API requests via Postman or other similar tools Experience running, managing, and deploying test infrastructure Benefits & Perks Competitive salary 100% individual and dependent medical + dental + vision coverage 401(k) with a 4% company match 20 days PTO Kandji Wellness Week the first week in July Equity for full-time employees Up to 16 weeks of paid leave for new parents Paid Family and Medical Leave Modern Health- Mental Health Benefits- Individual and Dependents Fertility Benefits Working Advantage Employee Discounts Free onsite fitness center Free parking Lunch 5 days/week Exciting opportunities for career growth An outstanding, inclusive culture We are excited to be serving a significant need for a fast-growing market, and are proud of the high-performing team we have brought together so far. If you're someone who wants to engage in new, exciting projects that will challenge your skills in the best way possible, we would love to connect with you. At Kandji we believe in fostering an inclusive environment in which employees feel encouraged to share their unique perspectives, leverage their strengths, and act authentically. We know that diverse teams are strong teams, and welcome those from all backgrounds and varying experiences. Kandji is proud to be an equal opportunity employer committed to diversity and inclusion in the workplace. Qualified applicants will be considered for employment without regard to race, color, religion, national origin, age, sex, sexual orientation, gender identity, physical or mental disability, protected veteran or military status or any other status protected by applicable law.

Posted 5 days ago

QA Engineer - Electrical-logo
QA Engineer - Electrical
Wilcox IndustriesNewington, NH
Wilcox Industries is looking for passion people who are excited to enable warfighters with leading edge tactical solutions. We currently have an opening for a full-time Quality Assurance Engineer (QE). This is an on-site position. This position is responsible for guiding efforts to identify and manage risks that could adversely affect plant or manufacturing business operations. This broad primary role includes loss elimination, risk management, and life cycle management. Roles and Responsibilities Support the Quality Management Systems. Formulates or helps to formulate Quality Assurance policies and procedures. Perform internal audits, generate audit reports, and communicate results. Designs and evaluates quality assurance processes, sampling systems, procedures, and statistical techniques. Works with Engineering on new products development to establish standards, testing and acceptance criteria. Designs or specifies inspection and testing mechanisms and equipment; analyzes production and service limitations and standards. Conducts training on quality assurance concepts, and tools. Evaluates, recommends, and facilitates lean activities for process improvement. Collects, organizes, monitors, and distributes information related to quality and process improvement functions, including but not limited to compliance to and documentation of quality management standards. Generates and analyze reports; distributes those reports to various users in the organization, customers and/or suppliers. Perform other duties as necessary when directed to do so to support business needs. Qualifications and Requirements Bachelor's Degree in Science or related work experience plus 2+ years' experience in quality, production management, engineering, or operations or a combination of education and experience. Background in Defense Industry a plus. Regular on-site attendance is a necessary function of this position. Ability to develop and manage good working relationships with internal departments (production, sales, logistics, accounting), contractors, suppliers inspectors and customers. Experience with ISO 9100: 2015 a plus Strong written and verbal communication skills. High attention to detail and excellent time management skills. Ability to identify issues and provide recommendations. Ability to work independently and as part of a team. Meet daily, weekly and monthly deadlines. Compensation offered may vary depending upon job-related knowledge, skills, and experience. Wilcox provides equal employment opportunity to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities LINKED

Posted 30+ days ago

Principal QA Automation Engineer-logo
Principal QA Automation Engineer
Rural SourcingDallas, TX
Team Sparq is committed to creating high-quality tech careers while helping clients accelerate their digital transformation journey. We are committed to being an inclusive workplace, maintaining a culture of equitable, diverse employment and advancement company-wide. C2C is not available Must be authorized to work in the U.S. without sponsorship Why you will enjoy Mondays again: Opportunity to collaborate with a diverse group of colleagues in a fun, creative environment Progressive career journey and opportunity for advancement Continuous development through training, mentorship and certification programs Exposure to modern technologies across various industries in an agile environment Ability to work in a hybrid model Competitive salary + bonus opportunities Robust benefits package, matching 401(k) plan, and substantial PTO Tuition reimbursement A Day in the Life: Design and implement automation testing strategies for SAP solutions, ensuring high-quality standards are met across all SAP modules Develop test plans and execute automated tests for SAP modules such as SAP S/4HANA, SAP FICO, SAP MM, and SAP SD Collaborate with cross-functional teams to design solutions and streamline testing processes for SAP upgrades, particularly migrations from ECC to S/4HANA Lead the Sparq QA team for the project, interfacing with client QA and management teams while directing the Sparq QA team. Review requirements and participate in architecture/design/code reviews with an emphasis on test automation strategy and adherence to coding standards Evaluate alternative technical solutions that best meet client needs and present the best option(s) Design and develop automated tests using a variety of languages (e.g. Java, C#, JavaScript), tools (e.g.Selenium, Cypress, Appium, Karate, Postman, JMeter), third party resources (e.g. BrowserStack, ReadyAPI) with a variety of test frameworks (e.g. Gherkin/BDD, TestNG, Jasmine) Create and manage Continuous Integration / Continuous Delivery environments using cloud providers (e.g. AWS, Azure) and containerized virtualization (e.g. Docker, Kubernetes) Build and maintain reusable testing infrastructure and frameworks including Mobile testing Triage failing automated tests, identifying those which truly are a defect in application code Help the development team debug application code, identifying root causes of defects Document test cases in a test management system, relating them both to the automation code and the requirements being tested What it takes: Consultative approach and problem solving skills to successfully align digital solutions with long-term business goals of the client Commitment to understanding and exceeding client expectations Ability to perform project oversight and execution of deliverables Flexibility to adapt within a high-growth organization Ability to lead, mentor and motivate those around them Hunger for continuous learning and professional development Intellectual curiosity to provide creative solutions Full understanding of the software development life cycle Ability to positively impact fellow colleagues through effective leadership, presentations, coaching, etc. Desire to work in a team environment Good interpersonal, written and verbal communication skills Equal Employment Opportunity Policy: Sparq is proud to offer equal employment opportunity without regard to age, color, disability, gender, gender identity, genetic information, marital status, military status, national origin, race, religion, sexual orientation, veteran status, or any other legally protected characteristic. #LI-HYBRID

Posted 30+ days ago

Lead Technician- QA - PAR (Night Shift)-logo
Lead Technician- QA - PAR (Night Shift)
Eli Lilly And CompanyConcord, CA
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: At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism. The Quality Assurance Floor Support Specialist is responsible for providing QA oversight to GMP operations. The role will provide QA support of the start-up and qualification of the Concord site. The QA Floor Support Specialist will demonstrate teamwork by collaborating cross functionally with various levels of the organization. As the project progresses, this role will transition to supporting and escalating issues from manufacturing to the site-based process team for one of the following manufacturing areas: Formulation and Equipment Preparation Processes Parenteral Filling (Pre-Filled Syringes) Automated and Semi-automated Visual Inspection Responsibilities: Support on-the-floor manufacturing activities with routine presence in the assigned manufacturing area. Follow good documentation practices and compliance with site procedures. Review and approve GMP documentation such as electronic batch records, logbooks, etc. Support creation of Standard Operating Procedures and associated Forms, Tools and Training. Troubleshoot and provide support to resolve equipment alarms and other issues in quality systems such as Trackwise and MES. Maintain open communications between cross functional teams and area leadership. Support the execution of inspection readiness activities including support of site self-inspections. Support project initiatives needed for the project and Quality function. Communicate any compliance issues associated with the project or site to Quality Management. Evaluate potential product quality impact for any GMP-related incident and support the investigation and assist with safety investigations. Basic Requirements: High School diploma or equivalent Knowledge of cGMP practices including good documentation practices, data integrity and regulatory compliance Demonstrated ability to communicate with cross-functional teams including good oral and written communication skills Strong attention to detail Ability to work independently with minimal supervision Proficiency with computer systems including Trackwise, MES, Microsoft Programs Responsible for maintaining a safe work environment, working safely & accountable for supporting all HSE Corporate, Project, and Site Goals Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for employment positions on the B paths or at R1 Level. Additional Skills/Preferences: Associates or Bachelors degree in a science, engineering, computer, or pharmaceutical related field of study, preferred Previous experience with GMP manufacturing equipment prep, formulation, filling, and visual inspection Previous experience with Manufacturing Execution Systems (MES) or electronic batch records Previous technical writing experience Technical aptitude and ability to train and mentor other team members Additional Information: Ability to work 12 hour shifts onsite on a rotating 2-2-3 schedule (not eligible for remote work) Overtime and off-shift support may be required May be required to respond to operational issues outside of core business hours and days May be subject to post-offer physical and vision exam Job is exposed to repetitive movements such as: Walking, Sitting, Bending, Twisting Must have ability to lift 30lbs 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 $28.12 - $51.68 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 30+ days ago

Qc/Qa Lab Technician-logo
Qc/Qa Lab Technician
Martin MariettaSisquoc, CA
Position Summary: Martin Marietta is seeking a qualified Quality Control Technician in Sisquoc, CA. Reporting to the Quality Control Manager, this position will support our vertically integrated business by providing quality control, quality assurance, material procurement, and product development services. Position Responsibilities: Conduct a complete pre-and post-shift safety inspections. Observe all safety precautions and rules specified by federal, state, and company regulations. Report unsafe conditions, accidents or incidents immediately to Lead person or Manager. Communicate with plant management on all safety and maintenance needs. Responsible for ensuring production samples from various plants are obtained and delivered to the central laboratory for testing. Perform physical testing of production samples (asphalt and aggregates) to ensure production runs are within specified limits. In contact with the production managers at various plants to relay quality issues that may arise and report test results. Uses test standards as listed in ASTM, Caltrans, AASHTO or other municipal specifications. Assist production with troubleshooting issues that may arise with respect to material quality. Obtains various products at our production facilities for testing purposes. Performs physical testing on production samples to ensure production runs are within specified limits. Data entry of information in daily reports from test performed. Must be able to work independently with little supervision. Self-starter is a must. Performs other duties and assignments as required. Position Requirements: High school diploma required Associate degree or industry certification such as ASTM, Caltrans, AASHTO, and ACI or 3 years' experience in related field preferred. 3 years of Technical/QC Services experience asphalt and aggregate testing preferred . Ability to perform/direct extensive asphalt, and aggregate testing. Excellent skills in collecting and organizing data. Excellent communication skills, both written and verbal Computer competency using Outlook, MS Office Products including Word, Excel, and PowerPoint Ability to be self-directed with minimal supervision. Frequently lifts up to 50 lbs. daily. May be required to work at heights of up to 30 feet. This job operates in a field environment. Also, working in inclement weather conditions, such as extreme heat, extreme cold, rain, ice, snow, and wind. The job duties do not cover all responsibilities and may require flexibility of shift and working hours.

Posted 4 days ago

Actionet, Inc. Careers - SLA QA Manager-logo
Actionet, Inc. Careers - SLA QA Manager
Actionet, Inc.Vienna, VA
Description ActioNet has an opportunity for a Quality Assurance Manager (QAM) requiring a Public-Trust clearance in the Washington, D.C., metro area. Hybrid work is available. You will play a multifaceted role as the main point of contact (POC) and be responsible for ensuring the highest standards of service and compliance within the Blanket Purchase Agreement (BPA). This individual is responsible for establishing, implementing, and maintaining quality assurance processes and frameworks that align with federal regulations and industry best practices. The QAM will work closely with project managers, engineers, and technical teams to identify and mitigate risks, improve performance, and drive continuous improvement initiatives. Additionally, QAM will oversee the documentation of processes, ensure compliance with contractual requirements, and provide leadership in quality control assessments. The right candidate will work well with a team, exhibit excellent customer service skills, be self-motivated, and seek ways to improve the environment. Duties and Responsibilities: Develop, implement, and oversee a Quality Assurance and Quality Control Plans to monitor and evaluate contractor performance against BPA standards and government QASP Establish and maintain quality control processes aligned with contract deliverables, ensuring compliance with FAR, NIST, and other federal regulations. Conduct performance assessments, audits, and compliance reviews to identify gaps and areas for improvement. Develop and manage Key Performance Indicators (KPIs) and Service Level Agreements (SLAs) to measure contractor performance. Lead the development of corrective and preventive action plans when performance deficiencies are identified. Work closely with the Contracting Officer's Representative (COR) and other stakeholders to ensure contract compliance. Facilitate regular quality reviews, status meetings, and reporting to provide insights on contract performance and compliance. Support risk management activities, identifying and mitigating risks related to IT infrastructure support services. Collaborate with project managers, technical teams, and other key personnel to ensure seamless integration of quality standards into contract execution. Oversee training programs related to QA processes and compliance requirements for project teams. Maintain detailed documentation of quality reviews, audit results, and corrective actions for contract reporting and federal audits. Basic Qualifications (required): Bachelor's degree in Quality Management, Business Administration, IT, or a related field. 8+ years of experience in quality assurance, contract compliance, or performance management within IT infrastructure or federal contracts. Strong knowledge of federal acquisition regulations (FAR), NIST guidelines, and IT security policies. Experience developing and implementing QA/QC Plans, SLAs, and KPIs in government contracts. Familiarity with IT service management (ITSM) frameworks such as ITIL or ISO 9001. Excellent analytical, problem-solving, and risk management skills. Strong written and verbal communication skills, including experience with audit reporting and compliance documentation. Ability to lead cross-functional teams and collaborate with government and contractor stakeholders. Preferred: Master's degree in Quality Assurance, Project Management, or IT-related field. Quality certifications such as Certified Manager of Quality/Organizational Excellence (CMQ/OE), Certified Quality Auditor (CQA), ITIL Certification, or PMP. Experience working on Blanket Purchase Agreements (BPAs) within federal agencies. Knowledge of cloud infrastructure services (AWS, Azure, Google Cloud) and data center operations. Familiarity with federal cybersecurity requirements (FedRAMP, FISMA, NIST 800-53, Zero Trust Architecture). Experience managing vendor and subcontractor performance in large-scale IT contracts. ActioNet is a CMMI-DEV Level 4, CMMI-SVC Level 4, ISO 20000, ISO 27001, ISO 9001, HDI-certified, woman-owned IT Solutions Provider with solid qualifications and expertise in Agile Software Engineering, Cloud Solutions, Cyber Security and IT Managed Services. With 24+ years of stellar past performance, ActioNet is the premier Trusted Innogrator! Why ActioNet? At ActioNet, our Passion for Quality is at the heart of everything we do: We are committed to making ActioNet a great place to work and continue to invest in our ActioNeters We are committed to our customers by driving and sustaining Service Delivery Excellence We are committed to giving back to our Community, helping others, and making the world a better place for the next generation ActioNet is proud to be named a Top Workplace for the tenth year (2014 - 2023). We have a 98% Customer retention rate. We are passionate about our customers' inspirational missions and entrust our employees and teams to deliver exceptional performance to enable our nation's safety, security, health, and well-being. What's in It For You? As an ActioNeter, you get to be part of an exceptional team and a corporate culture that nurtures mutual success for our customers, employees, and communities. We give you the tools to succeed; all you need to do is bring your best ideas, energy, and desire to develop your skills, experience, and career. Are you ready to make a difference? ActioNet is an equal-opportunity employer and values diversity at our company. We do not discriminate based on race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Posted 30+ days ago

Senior Specialist, QA Shop Floor-logo
Senior Specialist, QA Shop Floor
Bristol Myers SquibbSummit West, NJ
Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us. At Bristol Myers Squibb, we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there's no better place than here at BMS with our Cell Therapy team. The Shop Floor Quality Assurance team is responsible for 24x7 Quality collaboration and oversight of site operations, including but not limited to Manufacturing, Quality Control laboratories, and Warehouse Operations. This position will oversee and partner with Manufacturing/QC/Warehouse/Packout, to ensure compliance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP. Shifts Available: Monday- Friday, Onsite Day Shift, 9 a.m.- 5:30 p.m. Responsibilities: Provide Quality on-the-floor oversight to Manufacturing/QC/Warehouse/Packout operations. Identify departures from approved procedures & responding to complex issues independently and escalating critical issues to management. May perform and document operational verification per approved procedures. Develops, reviews and/ or approves temporary and non-routine procedure for event response. Observe manufacturing operations and identify departures from clean room behaviors and aseptic techniques. Provide quality oversight to non-routine maintenance work where applicable. Coordinate and lead area walkthroughs to identify quality issues. Negotiate remediations and drive alignment of implementation plans. Own shift actions for departmental programs and propose improvements to programs. Participate in Gemba walks. Review manufacturing or testing records to ensure compliance with approved procedures. Communicate and resolve discrepancies independently and escalate as required. Author, review, and approve procedural documents. Maintain compliance with assigned learning plan. Provide guidance and training for QA personnel. May own training curriculum and content. May present individual topics during audits as needed. Independently assess discrepancies for entry into quality system and approve deviations as applicable. May serve as quality subject matter expert for risk assessments, change controls, etc. Lead meetings and represent function at cross functional meetings. Share data/knowledge within and across team. Build & maintain strong relationships with partner functions. May prioritize and assign tasks for the team. Knowledge & Skills: Demonstrated experience with quality management systems. Demonstrated experience with electronic system and databases such as Manufacturing Execution systems (MES), Enterprise Resource Planning (ERP). Ability to research, understand, interpret and apply internal policies and regulatory guidelines. Proficient computer skills with knowledge of digital tools such as MS Office, etc. and ability to learn and work with new software applications. Ability to interpret data & results, understand complex problems with multiple variables, and articulate practical solutions. Excellent written and verbal skills and ability to present technical data effectively based on target audience. Ability to work in a fast-paced team environment and lead peers through changing priorities. Detail oriented and task focused with ability to meet deadlines and support work prioritization. Ability to negotiate and influence to craft mutually beneficial solutions. Ability to motivate and foster a positive team environment. Exhibit strong decision-making ability and think creatively while maintaining compliance and quality. Pioneering mindset and ability to create innovative solutions. Basic Requirements: Bachelor's degree in STEM field preferred. High school diploma/ associate's degree with equivalent combination of education and work experience may be considered. A minimum 4 years of relevant experience within Quality Assurance within a manufacturing GMP facility. A minimum of 2 years hands-on experience in QMS. A minimum of 2 years of experience with risk assessments. 1 year of deviation experience. Strong project management experience. The starting compensation for this job is a range from $83,900 to $101,700 plus incentive cash and stock opportunities (based on eligibility). The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit our BMS Careers Site. Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program. BMSCART, #LI-Onsite GPS_2025 If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as "Transforming patients' lives through science ", every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Posted 2 days ago

Senior Construction Qa/Qc Inspector-logo
Senior Construction Qa/Qc Inspector
Redwood MaterialsReno, NV
Senior Construction QA/QC Inspector Redwood Materials is currently seeking a Construction QA/QC Inspector to join our Engineering, Procurement, & Construction (EPC) team. These EPC roles are at the center of our activities focused on creating a sustainable circular economy for lithium-ion batteries by transforming recycled materials into battery materials for new lithium-ion battery production. The Quality Assurance/Control (QA/QC) Inspector will work closely with members of the project management, infrastructure engineering, project controls and procurement departments from installation through start of production. The QA/QC Specialist will document and manage quality of all construction scopes for a project within the RWM Quality Manual and engineering standards. Specifically, these tasks include coordination with trade subcontractors, vendor tool installations, resolving day to day quality issues, performing day to day inspections to ensure compliance with plans and specifications while tracking project schedule and budget. This role will report to the Sr. Quality manager and work directly with a Site Superintendent and Construction Manager. In many cases it will also be in tandem with a Construction Engineers, Subcontractors, and other project superintendents. This role will involve developing a Mechanical Integrity System for the company with the Sr. Quality Manager. Establishing the damage mechanisms, inspection points (CML's) and frequency. Responsibilities will include: Identifies risks at the project site and identifying discrepancies during daily site walks. Documents findings, evaluations and inspections using Company prescribed procedures and software. Assists with protocols, qualifications, and prescribed validation procedures and documentation. Performs system verifications on completed systems to assure correct installation per contract design specifications. Documents, analyzes and reports environmental performance to internal and external clients and regulatory bodies. Supports impact assessments to identify, assess and reduce the organization's environmental risks and financial costs, at the direction of the environmental team and procedures. Auditing of contractor and self-perform quality turn over documentation. MTR's, weld maps, logs, pwht and ndt reports. Maintains knowledge of Company's values and strategic plan. Support published corporate policies. Perform additional assignments per management's direction. Desired Qualifications: Current with an API 510/570 or CWI and obtain a CWI within 12 months. Required ASME B31.3, AWS D1.1 experience. Current CWI or obtain one within 12 months Level II NDT, MT, PT, UT-straight beam or obatin within 12 months. 10+ year related experience preferred. Valid driver's license required. Experience or training in construction industry compliance preferred. Leadership and mentoring ability and ownership. Strong organization and communication skills. Willingness and ability to learn and grow in inspection, monitoring, technical writing and documentation. A passion for sustainability and making the world a better place! Physical Requirements: Ability to safely and successfully perform the essential job functions consistent with the ADA, FMLA and other federal, state and local standards, including meeting qualitative and/or quantitative productivity standards. Ability to maintain regular, punctual attendance consistent with the ADA, FMLA and other federal, state and local standards Must be able to lift and carry up to 50 lbs. Must be able to talk, listen and speak clearly on telephone. Working Conditions: Environment, majority of the time will be in the office and Quality Lab with visits to the project sites. Exposures encountered, loud noise, or extreme heat/cold. Essential physical requirements include climbing, standing, stooping, lifting and typing. Offsite travel will be minimal.

Posted 30+ days ago

QA Coordinator-logo
QA Coordinator
AviagenLongview, TX
Job Description Summary: We are seeking an outstanding individual to fill the position of Quality Assurance Coordinator at Aviagen's Hatchery in Longview, TX. This role will primarily be responsible for verification of production processes, and monitoring of operational sanitation and plays a critical part of the hatchery team to ensure Aviagen's quality objectives are maintained and improved upon. The position will report directly to the Operations Manager. Job Description: The ideal candidate should have the following experience, skills, and attributes: Strong computer skills including Microsoft Excel (with Pivot Tables), PowerPoint, and Word. Able to work flexible hours. Typical work week is Monday - Friday. Must be able to perform occasional physically demanding aspects of the job. Bachelors of Science or equivalent. Ability to problem solve and think critically. Detail oriented, professional, strong organizational skills, and self-motivated. Preferred understanding of ISO 9001:2015 or equivalent. Preferred knowledge of hatchery operations or the poultry industry. The following duties will vary according to the needs of the organization. Normal duties will include, but are not limited to, the following: Quality Assurance checks on day old chicks and eggs. Observe and ask employees questions pertaining to job functions. Read processing information such as work instructions, worker logs, product processing sheets, and specification sheets to verify that records adhere to quality assurance specification. Aptitude to determine appropriate corrective actions and root cause analysis. Perform routine facility monitoring and sample collection. Interact and communicate with all levels of facility personnel. Write and submit reports to facility management and QA management team. Identify and rectify quality issues in the facility. Maintain and upload paperwork in a timely manner. Other duties as determine by the QA Management team. We offer: Affordable health insurance 401K PTO Paid holidays Bonus plan We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

Posted 30+ days ago

Sr. Director, Global QA Clinical Quality Assurance-logo
Sr. Director, Global QA Clinical Quality Assurance
Structure Therapeutics IncSouth San Francisco, CA
Structure Therapeutics develops life‐changing medicines for patients using advanced structure‐based and computational drug discovery technology. The company's platform combines the latest advancements in visualization of molecular interactions, computational chemistry, and data integration to design orally available, superior small molecule medicines that overcome current limitations of biologic and peptide drugs. We are advancing a clinical‐stage pipeline of differentiated treatments focused on chronic diseases with high unmet need, including cardiovascular, metabolic, and pulmonary conditions. Structure Therapeutics is led by an experienced group of international drug innovators and financed by top-tier global life sciences investors. The company has completed an initial public offering (IPO) in February of 2023. With offices in California and Shanghai, Structure Therapeutics has the benefit of being at the center of life science innovation in both the US and China and capitalizing on the strengths of each geographic location. POSITION SUMMARY The Sr. Director, Global QA Clinical Quality Assurance is responsible for development, governance, and management of GCP and ensuring other product development and PV activities comply with applicable national and international standards, regulations, and guidelines. The position will provide support and promote collaboration internally to ensure all systems, processes and their outcomes remain compliant. The position will also provide quality oversight of multiple programs in development, based on company goals. Preference is for local candidates, and we are moving to a 4-day work week/in the SSF QC office If remote, you will be required to work in SSF QC office one week a month ESSENTIAL DUTIES AND RESPONSIBILITIES Support the preparation and implementation of regulatory strategies, for new drug Lead Clinical Quality oversight, including creation and revision of SOPs and training programs for GCP compliance Ensure involvement of Quality from early phases of development through collaboration with Clinical Science, Clinical Operations, RA, PV etc. to influence effective processes and program oversight Lead in preparation and support of regulatory inspections and partner diligence audits in cooperation with multiple internal functions as well as external vendors/3rd parties. Provide training and support for inspections at sites, CROs and service providers Serve as QA representative on clinical study development teams; participate in the review and approval of clinical trial "essential documents" (e.g. protocols, ICF, etc.) Evaluate vendors for potential use; conduct and/or manage qualification inspections of GCP suppliers and service providers Create and execute clinical study audit plans, perform routine and for-cause audits of clinical investigator sites, and review of TMFs and CSRs Lead and participate in cross functional working groups to identify and mitigate GCP quality and compliance issues. Create, monitor, and improve a QMS with focus on development phases Oversee GCP activities (including internal or external audit observations and development of adverse trends) in order to ensure patient safety and data integrity Lead, investigate, and/or oversee quality issues including CAPAs and closures including defining and monitoring key quality metrics in support of management reviews Participate in department cross-training and lead/support during regulatory inspections, serving as QA clinical expert and host inspections as needed. Assess GCP and GLP compliance risk areas and develop and implement risk mitigation measures Maintain a contemporary knowledge of current agency and industry trends, standards, and methodologies as related to GCPs Other duties as assigned REQUIREMENTS Education BS/MS or equivalent in a relevant scientific discipline. Graduate level in a science or engineering related discipline preferred Experience 10 -12+ years' experience in clinical quality assurance ensuring sponsor oversight including performing GCP audits for clinical stage pharmaceutical companies with at least 5 years' experience in an out-sourced environment Thorough experience in quality function, overseeing clinical quality within European guidelines and regulatory standards 5+ years' experience with Pharmaceutical Quality Assurance in the US. Strong HA inspection experience with FDA, MHRA, EMA, and/or PMDA is desirable Has a bias for action and display a sense of urgency Must possess strong skills in leadership, communication, project management, and budget management Demonstrated ability to collaborate, communicate and ensure quality oversight through external parties A working knowledge of databases, including Electronic Document Management Systems (EDMS), is desirable In‐depth knowledge of and ability to interpret and apply GCP, GLP, EU, FDA and ICH regulations, guidelines, and best practices SQA RQAP certification is a plus Full understanding of and practical experience establishing and fostering compliance with ICH E-6 Guideline for Good Clinical Practice and Good Pharmacovigilance Additional certifications as an auditor as well as training regulatory frameworks highly desirable. Expertise in data integrity and CFR Part 11 required Ability to travel 10-30% domestically and internationally The target salary range for this full-time role is $255,000 - $306,000 + bonus + equity + benefits. Structure Therapeutics determines salary ranges based on level and scope of responsibilities, as well as location. Individual pay is further determined by additional factors, including relevant experience, specific job skills, education and training. More details about the specific salary range for your location will be discussed with you during the hiring process by the StructureTx Talent Acquisition Team.

Posted 30+ days ago

Lead Construction Qa/Qc - Disaster Recovery-logo
Lead Construction Qa/Qc - Disaster Recovery
ICF International, IncTallahassee, FL
Join the ICF team and make a difference! Our growing Disaster Management Division makes BIG things happen every day. ICF is seeking a Construction QA/QC Lead to assist the State of Florida with managing federal disaster recovery grant programs and carrying out strategic, high-impact activities to rebuild housing, strengthen communities, and mitigate future disaster risks. The right candidate will have experience in the U.S. Department of Housing and Urban Development's (HUD) Community Development Block Grant (CDBG), Community Development Block Grant- Disaster Recovery (CDBG-DR), and Community Development Block Grant- Mitigation (CDBG-MIT) programs, as well as an understanding of other federal disaster recovery programs and applicable cross-cutting requirements. You will work with other senior staff, subject matter experts, and junior staff to quality assure all construction documentation, develop and deliver training and technical assistance, and support all construction-related activities in Florida's disaster recovery and mitigation efforts. This position requires flexibility, critical thinking, and the ability to adjust to an ever-changing environment. Key Responsibilities: Work as part of a team providing expert services to support disaster recovery and mitigation efforts, focusing on QA/QC of construction activities. Manage a team of QA/QC specialists. Ensure quality and accuracy of inspections, cost estimations, scopes of work, builder invoices, cost reasonableness determinations, and environmental requirements (lead-based paint, asbestos, mold, Section 106 compliance). Review inspector and builder change order requests for reasonableness and necessity. Review and verify milestone inspection documentation for completeness, accuracy, and consistency with the approved project scope. Ensure all required programmatic documentation is accurately supplied and entered into the system of record. Review builder assignment methodologies, builder performance scoring, and contractor compliance with program standards. Assist with the development and refinement of QA/QC policies, procedures, and processes for implementation and training. Support field teams and provide operational guidance on quality assurance best practices. Other tasks, as assigned. Minimum Qualifications: Bachelor's degree in Construction Management, Engineering, Architecture, or a related field (or 3 years of experience with CDBG-DR construction programs in lieu of a degree). 2+ years of experience supporting CDBG-DR or CDBG-MIT housing recovery construction programs. Proficiency with Xactimate X or later versions as it relates to CDBG-DR construction, damage assessments, and cost estimates. Knowledge of IRC 2021, IBC 2021, Florida Building Code, and residential construction and resilient building practices. Proficiency in Microsoft Excel, including use of advanced formulas, charts, and formatting to create client-ready deliverables. Ability to manage multiple people and projects, and tasks simultaneously in a fast-paced environment. Strong attention to detail, communication, and problem-solving skills. Ability to work independently or collaboratively as part of a multidisciplinary team. Other Job Details: Remote position with possible travel to client sites and field offices throughout Florida. Full-time position. Working at ICF ICF is a global advisory and technology services provider, but we're not your typical consultants. We combine unmatched expertise with cutting-edge technology to help clients solve their most complex challenges, navigate change, and shape the future. We can only solve the world's toughest challenges by building a workplace that allows everyone to thrive. We are an equal opportunity employer. Together, our employees are empowered to share their expertise and collaborate with others to achieve personal and professional goals. For more information, please read our EEO policy. Reasonable Accommodations are available, including, but not limited to, for disabled veterans, individuals with disabilities, and individuals with sincerely held religious beliefs, in all phases of the application and employment process. To request an accommodation, please email Candidateaccommodation@icf.com and we will be happy to assist. All information you provide will be kept confidential and will be used only to the extent required to provide needed reasonable accommodations. Read more about workplace discrimination rights or our benefit offerings which are included in the Transparency in (Benefits) Coverage Act. Candidate AI Usage Policy At ICF, we are committed to ensuring a fair interview process for all candidates based on their own skills and knowledge. As part of this commitment, the use of artificial intelligence (AI) tools to generate or assist with responses during interviews (whether in-person or virtual) is not permitted. This policy is in place to maintain the integrity and authenticity of the interview process. However, we understand that some candidates may require accommodation that involves the use of AI. If such an accommodation is needed, candidates are instructed to contact us in advance at candidateaccommodation@icf.com. We are dedicated to providing the necessary support to ensure that all candidates have an equal opportunity to succeed. Pay Range- There are multiple factors that are considered in determining final pay for a position, including, but not limited to, relevant work experience, skills, certifications and competencies that align to the specified role, geographic location, education and certifications as well as contract provisions regarding labor categories that are specific to the position. The pay range for this position based on full-time employment is: $80,708.00 - $137,203.00 Florida Remote Office (FL99)

Posted 30+ days ago

VP, QA, Food Safety And Regulatory Compliance-logo
VP, QA, Food Safety And Regulatory Compliance
Cabot Creamerycabot, VT
How would we describe a career with Agri-Mark/McCadam/Cabot Creamery? More than 100 years of: Farmers, Family, Mission, Purpose, Sustainability, Respect, Integrity, Work Ethic, Teamwork, Pride in Award Winning Products, and Agriculture. Cabot Creamery achieved B Corp certification in 2012 and became the world's first dairy co-op to do so. This certification demonstrates our commitment to transforming the global economy to benefit all people, communities, and the planet. The Vice President of Quality Assurance, Food Safety & Regulatory Compliance is responsible for developing and implementing company-wide food safety and quality standards in alignment with industry regulations and best practices reflecting our company's commitment to producing the highest quality dairy products. This executive will lead all aspects of food safety, quality assurance, and regulatory compliance across our dairy manufacturing, warehousing and distribution operations, ensuring consistent implementation of best practices in food safety, quality systems, HACCP, GMPs, and continuous improvement. This role is instrumental in protecting our brand, maintaining customer and consumer trust, and ensuring alignment with FDA, USDA, USPH, FSMA, and other applicable regulatory frameworks. What you'll be doing: Food Safety and Quality Assurance Leadership: Develop, implement, and maintain robust quality management systems across all plants and supply chains. Oversee quality control procedures, microbiological testing, pathogen environmental monitoring, product specifications and hold and release programs to maintain consistency and excellence. Promote Food Safety Culture by providing visible leadership, promoting interdepartmental collaboration and establishing an environment of psychological safety where employees freely escalate food safety and quality issues. Oversee all internal and external audits, quality certifications, and inspection readiness ensuring dairy plants maintain required certifications. Ensure that all processes meet or exceed customer expectations, food safety requirements and regulatory standards. Manage supplier relationships to assure raw materials meet quality specifications and standards. Maintain a supplier approval process to mitigate supply chain risk. Drive continuous improvement initiatives in food safety, product quality, and manufacturing processes using tools like root cause analysis, and statistical process control. Regulatory & Compliance: Ensure full compliance with local, state, and federal food regulations (e.g., FDA, USDA, FSMA, PMO, etc.). Ensure product labeling compliance to include preserved identity items (Kosher, HALAL, rBST, GMO status, Natural). Maintain relationships and committee participation with industry associations including IDFA, USDEC, and the Innovation Center for US Dairy. Lead investigations of quality incidents, regulatory agency inquiries, customer complaints, and product recalls, implementing corrective and preventive actions. Monitor and interpret new or changing legislation and regulatory trends; advise executive leadership on potential impacts and mitigation plans. Team Development & Cross-Functional Collaboration: Lead and mentor a high-performing QA/QC, food safety, and compliance team across multiple facilities. Collaborate closely with R&D, operations, procurement, and legal teams to ensure quality standards are embedded throughout the product lifecycle. Serve as a key liaison with major retail and foodservice customers, auditors, and certification bodies. Strategic & Operational Excellence: Develop short and long-term strategies to enhance product quality, customer satisfaction, and risk mitigation. Establish and track KPIs and metrics related to quality, food safety, and compliance performance. Champion a culture of food safety and quality assurance throughout the organization. What we are seeking: Bachelor's degree in Food Science, Microbiology, Dairy Science, or a related field (Master's preferred). Minimum of 10-15 years of progressive experience in quality assurance and food safety within the dairy or broader food manufacturing industry. Proven track record in regulatory compliance and quality systems leadership, preferably in multi-site operations. In-depth knowledge of dairy processing, pasteurization, State Department of Agriculture, environmental pathogen monitoring, pest control, sanitation, GMP requirements, HACCP, FSMA, USPH, FDA, USDA and food safety regulations. Experience with third-party certification programs such as SQF, BRC, or ISO 22000. Ability to work collaboratively with cross-functional teams and influence stakeholders at all levels. Proficiency in quality management systems, data analysis, and continuous improvement methodologies. Strong leadership, communication, and problem-solving skills. Familiarity with emerging dairy industry trends and technologies. Certification in relevant QA/Food Safety programs (e.g., HACCP, PCQI, SQF Practitioner) is highly desirable. Salary range $175-185k with bonus (dependent upon company/individual performance) This role will require travel to our various plant locations VT/NY/MA

Posted 2 weeks ago

QA Systems Analyst Lead-logo
QA Systems Analyst Lead
Loan DepotIrvine, CA
Position Summary: The QA Systems Analyst Lead is responsible for coordinating and organizing QA team activities and sprint tasks. Keeps existing test cases up-to-date and creates new cases when issues are resolved or features are introduced. Involved in the execution of test plans and reporting of any issues into our issue tracking system. Works closely with the product management and design teams to understand and give feedback on new features. This role requires experience in establishing QA Procedures, proficiency in drafting Test strategies, documenting the Testing Procedures and managing the team to meet the Testing Cycle. Responsibilities: Provides leadership to QA analysts, with complete responsibility and accountability for delivery of project tasks assigned. Performs quality assurance/software testing processes, methodologies, and procedures as part of contributing to software quality. Ensure systems meet business requirements and quality standards through QA best practices. Collaborates with business and IT teams and participates in defect triage meetings. Actively participates in establishing project plans, estimating work and monitoring progress against milestones and deliverables. Completes test planning, functional testing, regression testing, integration testing, user acceptance testing, along with troubleshooting concerns addressed and debugging. Involved in after-hours deployment efforts and post-deployment verification testing. Develop testing solutions for teams to increase efficiency. Performs other duties and projects assigned. Requirements: Bachelor's Degree required with a minimum of eight (8) + years of work experience in software quality assurance. Minimum of five (5) + years of QA Lead experience, working with both offsite and onsite teams. Minimum of two (2) + years of experience with MTM and SQL. Minimum of one (1) + years of experience testing web services, working in an Agile/Scrum methodology, and using Jira for defect tracking. Mortgage experience desired. Empower LOS experience a plus. Experience working in an agile/Sprint model is a plus. Demonstrates knowledge of the QA testing methods: unit, integration, regression, user acceptance testing. Demonstrates ability to perform root cause analysis. Strong analytical skills with keen attention to detail. Demonstrates knowledge of MTM, JIRA or other Test Management tools. Intermediate skills in computer terminal and personal computer operation; Microsoft Office applications including but not limited to: Word, Excel, PowerPoint, and Outlook. Intermediate math skills; calculating interest and percentages; balance accounts; adding, subtract, multiply and divide in all units of measure, using whole numbers, common fractions, and decimals; locate routine mathematical errors; compute rate, ratio and percent, including the drafting and interpretation of bar graphs. Effective organizational and time management skills. Exceptional verbal, written and interpersonal communication skills. Ability to make decisions that have moderate impact on the immediate work unit and cross functional departments. Ability to organize and prioritize work schedules on a short-term and long-term basis. Ability to make informal and formal presentations, inside and outside the organization; speaking before assigned team or other groups as needed. Ability to deal with complex difficult problems involving multiple facets and variables in nonstandardized situations. Ability to work with no supervision while performing duties. Ability to work under pressure and to meet tight deadlines in fast paced, dynamic environments. Excellent interpersonal and organizational skills, ability to handle diverse situations, multiple projects, and rapidly changing priorities Excellent written, verbal, and presentation communication skills, especially in representing your technical expertise to a diverse audience. Why work for #teamloanDepot: Competitive compensation package based on experience, skillset and overall fit for #TeamloanDepot. Inclusive, diverse, and collaborative culture where people from all backgrounds can thrive Work with other passionate, purposeful, and customer-centric people Extensive internal growth and professional development opportunities including tuition reimbursement Comprehensive benefits package including Medical/Dental/Vision Wellness program to support both mental and physical health Generous paid time off for both exempt and non-exempt positions About loanDepot: loanDepot (NYSE: LDI) is a digital commerce company committed to serving its customers throughout the home ownership journey. Since its launch in 2010, loanDepot has revolutionized the mortgage industry with a digital-first approach that makes it easier, faster, and less stressful to purchase or refinance a home. Today, as the nation's second largest non-bank retail mortgage lender, loanDepot enables customers to achieve the American dream of homeownership through a broad suite of lending and real estate services that simplify one of life's most complex transactions. With headquarters in Southern California and offices nationwide, loanDepot is committed to serving the communities in which its team lives and works through a variety of local, regional, and national philanthropic efforts. Base pay is one part of our total compensation package and is determined within a range. This provides the opportunity to progress as you grow and develop within a role. The base pay for this role is between $106,000 and $145,000. Your base pay will depend on multiple individualized factors, including your job-related knowledge/skills, qualifications, experience, and market location. We are an equal opportunity employer and value diversity in our company. We do not discriminate based on race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Posted 2 weeks ago

Joint Use Design Qa/Qc - Remote Work-logo
Joint Use Design Qa/Qc - Remote Work
Orbital Engineering, Inc.Pittsburgh, PA
Joint Use Design QA/QC Working with our business partners to create, improve and sustain industry and infrastructure. Orbital Engineering has been driven by this core purpose for more than 50 years - energizing Orbital team members and helping our clients solve challenging and complex problems with innovative engineering, inspection, and construction solutions. Orbital team members are guided by the fundamental beliefs of building trusted relationships, personal accountability, innovation, and excellence in everything we do. Orbital is looking for others to join our team to continue activating our purpose and embrace our values. Orbital Engineering's Utility Infrastructure Improvement (UII) Department partners with Utility and Communication Companies in Engineering and Construction operations for Joint Use Pole Attachment Programs (JU), Distribution Engineering Design Projects, and Distribution System Improvement Charge (DSIC) programs, such as the Pennsylvania Long-Term Infrastructure Improvement Program (LTIIP). This Joint Use Design QA/QC position will directly support projects within the UII Department's pole attachment application process and power delivery improvement process. The team is also responsible for analyzing requests for attachment to client's poles and network reliability improvements on client's electric distribution systems. The staff also support GIS data analytics, creation of notifications, work orders, invoicing, and financial reports utilizing enterprise resource planning software. Orbital Engineering, Inc. is currently seeking a Joint Use Designer to serve in a QA/QC role and be based in a REMOTE WORK position. Responsibilities include but are not limited to: Ensure Orbital's QA/QC process is followed in order to validate all project deliverables prior to submission to the client. Conduct a thorough review of design packages to ensure compliance with NESC, Orbital and client standards. Provide timely feedback and technical guidance to less experienced team members in order to improve overall design quality and increase efficiency. Visually identify, inspect, and record equipment and different construction situations in the field, including rights-of-way Apply National Electric Safety Code (NESC) Standards, Client Standards, Federal, State or Local Municipal Guidelines, and/or other applicable guidelines to complete engineering designs (Pole Replacements, Communication Space Rearrangements, Joint-Use Design) for possible joint-use or make-ready construction Ability to analyze field collected data (including imagery) and accurately update applicable software packages for successful design implementation Regularly utilizes Client proprietary software packages or equipment to complete daily responsibilities in the engineering design workflow process, may include facilitating new attachment permitting process Communicate with others, including co-workers and clients, to agree on the best solution for engineering design Accountable for work assigned and responsible for completing work on project schedule and within project budget while regularly communicating status with management team Frequently communicates with Client(s) on engineering design to best determine the most cost-effective solution for their project Provides timely and detailed documentation and support to Orbital accounting functions for ensuring projects are on budget and appropriately accounted Can transcribe notes, use measuring devices to identify, inspect, and record the data which is found in an organized manner Can endure frequent driving, standing, walking (numerous miles a day), navigating (on foot or in a vehicle), and balancing objects which may weigh up to 20 pounds in congested and/or complex terrain As needed, must be able to work in all weather conditions and in residential, commercial, and industrial areas Work is primarily office based but fieldwork may be needed throughout the engineering design process Must be willing to travel overnight or for extended periods of time, based on project assignment Will be required to attend meetings at clients' sites and regularly interact with the general public, including landowners and operators May occasionally enter energized extra-high voltage substations up to 745kV and will need to coordinate with appropriate utility personnel throughout fielding activities within this location Minimum Requirements Demonstrated experience serving in a QA/QC role in a Joint Use / Make Ready design environment. Proficiency with NESC requirements Ability to interpret client design standards and readily apply them to design deliverables. Ability to convey, verbally and electronically, constructive feedback to junior team members in order to remedy design deficiencies. High School Diploma or GED required with 3+ years of experience in fieldwork or a construction environment, drafting, utility experience, or technical design Associates Degree in Engineering, Engineering Technology, or related technical discipline with 0-2 years of experience, with interest in fieldwork, or surveying Must be an organized person who can keep data organized from start to finish on a project Ability to prioritize work on multiple projects and effectively communicate project statuses Computer proficiency including general Microsoft Office products, design, and business enterprise software Effective written and oral communication at all levels within an organizational structure Reasoning skills and ability to solve practical problems Must have dependable transportation and a valid driver's license with insurance Must be able to pass a fit for duty test Ability to work from home and an office setting, as required This position requires the ability to pass a post-offer drug (including marijuana) and alcohol test in compliance with Federal regulations and is also subject to random testing as a condition of continued employment. Preferred Qualifications Ability to read and understand engineering drawings/schematics Working knowledge of electrical distribution assets and/or communication equipment construction Experience in pole loading (Spida Calc, O-Calc, Pole Foreman, or Katapult) or other construction modeling software (AutoCAD) is beneficial Knowledge of industry utility or joint-use software (SPANS, NJUNS, IkeGPS) for make-ready engineering and construction is beneficial Familiar with Design and Checking practices for engineering drawings and deliverables Familiar with Safe Work Practices and PPE applications Preferred previous experience completing Joint-Use Make Ready designs Orbital Engineering, Inc. has provided worldwide professional engineering and consulting services since 1969. Our commitment to quality, responsiveness, and attention to detail has earned us the reputation as a leading provider of engineering and design services. A commitment to excellence and hard work will be rewarded with a competitive salary, career advancement opportunities, and an excellent benefits package including medical, dental, vision, prescription drug, 401(k), and supplemental insurance. Orbital Engineering, Inc. is an Equal Opportunity Employer, EEO/AA/M-F-V-D. Orbital Engineering, Inc. seeks diversity among its employees. Reasonable accommodations may be made to enable individuals to perform the essential job functions. JOI00001935 #LI-CV1

Posted 30+ days ago

Qa/Compliance Administrator-logo
Qa/Compliance Administrator
Feld EntertainmentEllenton, FL
The QA/Compliance Administrator will take a proactive leadership role in ensuring compliance with industry standards and regulations. This position requires a strategic thinker who can assess compliance needs, make informed decisions, and implement solutions that enhance operational efficiency. The Compliance Administrator will oversee key compliance initiatives, manage critical communications, and drive data analysis and document management efforts. This role involves evaluating compliance procedures, recommending improvements, and enforcing policies to maintain regulatory standards and ensure organizational success. Essential Functions Lead Compliance Programs: Provide high-level oversight for the Code of Conduct program, ensuring all requirements are met. Identify compliance gaps, implement corrective actions, and enforce policies to maintain industry standards. Manage Supplier Training & Compliance- Lead training initiatives and collaborate with suppliers to ensure proper labeling and packaging of products in adherence to company standards. Proactively address non-compliance issues to uphold company requirements. Financial Compliance Management- Oversee invoice submissions to Accounts Payable, ensuring accuracy, compliance, and timely processing. Investigate and resolve discrepancies, making informed decisions to streamline payment operations. Data Oversight & Process Optimization- Analyze inspection and test reports to assess vendor and testing company compliance. Identify trends, recommend process improvements, and implement tracking enhancements to strengthen compliance initiatives. Strategic Compliance Leadership: Identify areas for operational improvement, develop recommendations, and implement decisions that enhance departmental efficiency and compliance effectiveness. Required Qualifications Bachelor's degree in business administration or a related field. Advanced expertise in Microsoft Excel, including skills in functions such as VLOOKUP, PivotTables, and data analysis tools, is required to support quality assurance reporting and data management tasks. Strong Excel expertise is essential for success in this role, as it underpins critical QA processes and decision-making. Strong Decision-Making Skills: Ability to assess compliance situations and make effective administrative and procedural decisions. Exceptional Communication Abilities: I have excellent written and verbal communication skills for engaging with internal teams, clients, and regulatory bodies. Detail-Oriented Leadership: Strong organizational skills with the ability to simultaneously meet firm deadlines and oversee multiple compliance initiatives. Time Management & Prioritization: Ability to effectively prioritize tasks and manage complex workflows.

Posted 30+ days ago

KBI Biopharma logo
QA Specialist I/Ii
KBI BiopharmaDurham, NC
Apply

Automate your job search with Sonara.

Submit 10x as many applications with less effort than one manual application.1

Reclaim your time by letting our AI handle the grunt work of job searching.

We continuously scan millions of openings to find your top matches.

pay-wall

Job Description

At KBI Biopharma, we are advancing science and accelerating breakthroughs. As a global leader in biopharmaceutical development and manufacturing, we empower life science companies to bring new medicines and vaccines to the world faster. Explore your potential at KBI, where innovation meets impact.

The Manufacturing Quality Assurance (MQA) Specialist is responsible for supporting the Manufacturing Process and Areas as part of a rapidly expanding GMP Contract Manufacturing Organization. MQA Specialists are expected to provide sound guidance to Manufacturing with respect to process, SISPQ of product, and risk. MQA Specialists share responsibility for the inspection readiness of the site. MQA Specialists routinely work on the cleanroom floor directly with the Manufacturing team to provide real time guidance and support. Specialists routinely collaborate with Manufacturing and work on team initiatives. The MQA Specialist may also be responsible for coaching and mentoring as needed to foster a GMP compliant site. In addition to supporting Manufacturing, MQA Specialists are responsible for the execution of core activities during a 12-hour 2-2-3 schedule, including but not limited to:

  • Executed Batch record review and approval
  • Logbook review and approval
  • Deviation guidance and generation
  • Routine facility walkthroughs
  • Facility response for work compromising clean environment.
  • SOP review
  • Bulk Fill Label reconciliation
  • Alarm response and acknowledgement
  • Support external client review and resolution of comments.
  • Creation and Release of electronic Batch Records, electronic Solution Records, electronic Equipment Preparation Records, etc. in MODA-ES Admin Client

MQA Specialist I

  • High School diploma or equivalent. Degree progression preferred.
  • GMP / regulated industry / laboratory experience is required (approximate 1-3 years).
  • Demonstrated ability to work in a team environment.
  • Demonstrated ability to understand the manufacturing process.
  • Ability to perform routine core MQA responsibilities.
  • Review written procedures for accuracy and provide feedback as needed

MQA Specialist II

  • Associate degree / Bachelor's degree strongly preferred or appropriate years of experience (approximate 3-6 years).
  • Demonstrated ability to work in a team environment and strong communication skills within all levels of an organization.
  • Demonstrated ability to represent Quality on interdepartmental meetings.
  • Demonstrated knowledge of technical documents.
  • Demonstrated ability to become qualified trainers.
  • Ability to track and trend department metrics.
  • Review written procedures for accuracy and provide feedback as needed

Salary Range:

  • MQA Specialist I: $55,000 - $75,900

  • MQA Specialist II: $63,000 - $86,900

Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidate's qualifications and experience and may be outside this range. KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, 401K matching with 100% vesting in 60 days and employee recognition programs.

About KBI:

KBI Biopharma, Inc., a JSR Life Sciences company, is a global contract development and manufacturing organization (CDMO) providing fully integrated and accelerated drug development and biologics manufacturing services to life science companies. KBI supports its 500+ customers in advancing more than 160 drug candidates from preclinical and clinical stages to market, including the manufacture of ten commercial products. Recognized for quality manufacturing, KBI delivers robust process development and cGMP manufacturing services across its six global locations in the USA and Europe. For more information, visit www.kbibiopharma.com.

KBI is a proud EEO/AA employer dedicated to building a diverse and inclusive workforce. We believe that innovation thrives in an environment where all voices are heard and valued. That's why we actively seek individuals from all backgrounds - regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability, or veteran status - and strongly encourage all qualified candidates to apply and bring their unique perspectives to our team.

KBI Biopharma is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must inform KBI Biopharma of their vaccination status and must submit their vaccination status. All vaccinated employees are required to provide proof of their COVID-19 vaccination, with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization.

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.

I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary.

I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.