Top QA Jobs Hiring Now - Apply with AI Matching

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

Eli Lilly and Company logo

Scientist - Idap Packaging QA Flow Mentor

Eli Lilly and CompanyIndianapolis, IN

$65,250 - $169,400 / year

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world. Organization Overview 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. Position Brand Description: The Scientist- IDAP quality assurance flow mentor provides technical leadership and expertise for quality production support in the following areas: coaching and mentoring QA floor reps, developing and sustaining process knowledge, process and equipment support, process optimization and continuous improvement, sustaining quality management systems, and adherence to business processes. The Scientist- IDAP quality assurance flow mentor participates in regulatory inspections, collaborates in the site inspection readiness program, supports the APR process, and advises lead investigators, functional leaders, and site quality leader on production issues. Key Objectives / Deliverables: Coach and mentor QA floor reps through onboarding and qualification. Coach and mentor QA floor reps in process understanding, problem solving, project management, and deviation resolution. Support and peer review root cause analysis around operational events. Promote and peer review documentation of learning points, gap assessments, and deviations. Provide technical support to non-routine investigations and lead investigations for the quality function. Work within cross-functional teams in a positive fashion to implement QA objectives and deliver on business plan and quality objectives. Provide process and equipment support through identification of systemic issues affecting production (deviations, cycle time delays, etc.) Lead or participate in root cause analysis and countermeasure development and implementation for major compliance or throughput event investigations. Perform reviews of event documentation for technical accuracy and compliance. Provide back up and shutdown support for QA floor reps as needed. Identify and drive alignment of QA systems across IDAP. Support APR program. Support development and technical analysis for large-scale initiatives (secondary loop projects) such as productivity improvements, capacity development, GMP remediation, and safety risk mitigation. Review and identify opportunities for continuous improvement and assist in prioritization of opportunities with respect to overall business objectives. Collaborate with key support groups around the development of process knowledge and a common process improvement agenda. Provide independent peer input / review of technical activities. Provide support to the QA organization for deviation reduction and backlog prevention initiatives. Analyze process team metrics for awareness and identification of potential improvement opportunities. Basic Requirements: Bachelor's Degree or equivalent work experience 3 or more years in the pharmaceutical industry Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1. Additional Preferences: Demonstrated strong oral and written communication and interpersonal skills. Demonstrated decision making and problem-solving skills. Demonstrated knowledge and understanding of manufacturing process and Quality Systems. Demonstrated attention to detail. Demonstrated ability to organize and prioritize multiple tasks. Experience in Quality, TS/MS, or engineering is preferred. Experience in device assembly and packaging processes. Good knowledge of cGMP, external regulations and Lilly quality systems and requirements. Experience leading root cause investigations. Excellent technical writing skills. Ability to function in a team environment as a leader and as a member of teams. Ability to partner / network outside the IDAP site and participate in inspection readiness / continuous improvement initiatives. Other Information: The normal schedule for this position is Monday- Friday, 8 hours/day. However, back-up for floor QA reps and planned shutdown support may require support outside the normal schedule. Travel (domestic and international) may be required. Applicant may work in various areas within the IDAP plant. Some allergens are present in the IDAP plant. Mobility requirements and exposure to allergens should be considered when applying for this position. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( https://careers.lilly.com/us/en/workplace-accommodation ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $65,250 - $169,400 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly

Posted 2 weeks ago

Benteler logo

Quality Engineer - Qa/Metallurgist

BentelerShreveport, LA
Division: BENTELER Steel/Tube Functional Area: Quality Management Career Level: Professional Contract Type: Permanent/Full-time Weekly Working Hours: 40,00 Required Languages: English Requisition ID: 44366 Benefits: United States : 401(k) Match || United States : Dental || United States : Development || United States : Educational Assistance || United States : Flexible Work Schedules || United States : Health Savings Accounts || United States : Holidays || United States : Life & Disability || United States : Medical || United States : Training || United States : Vacation || United States : Vision || United States : Wealth Management Support At BENTELER, we make it possible. From promoting individual talents to international career prospects, or from generous opportunities for designing your career to personal development opportunities-at BENTELER, we always have answers to your questions about the future, based entirely on your personal needs. Diverse options that makes sure you can be anything and everything. Or, as we like to put it: BENTELER makes it happen! Core Responsibilities: Ensuring quality: Ensuring the quality of parts produced by Benteler meets customer requirements and industry standards. Material and process control: Monitoring and controlling materials and manufacturing processes to ensure they meet specifications. Quality issue investigation: Investigating quality issues and recommending corrective actions. Data analysis and reporting: Analyzing data related to quality issues and preparing reports. Communication and collaboration: Communicating with different departments, including customers and suppliers, to address quality concerns and implement quality improvement initiatives. Process improvement: Identifying opportunities for process improvement and implementing changes to enhance quality. Non-destructive testing (NDT): Utilizing NDT methods to inspect products and materials. Product development: Participating in product development activities, providing technical expertise in quality aspects Job Requirements: Bachelor in Metallurgical Engineering / Material Sciences or related field. Years of industry experience: Minimum 3 years of Metallurgical experience in the Steel Industry Experience with tubular and/ or steel manufacturing is preferred. Project management experience: Experience in project management, particularly in quality-related projects. Experience with NDT methods: Familiarity with various NDT methods (e.g., X-ray, ultrasonic testing). Software proficiency: Proficiency in MS Office, SAP, and other relevant software. Knowledge of quality standards and regulations: A strong understanding of relevant quality standards and regulations, such as API, ASTM, and ASME. Problem-solving skills: Ability to identify, analyze, and resolve quality issues. Communication skills: Excellent written and verbal communication skills. Analytical skills: Ability to analyze data and draw conclusions. Organizational skills: Strong organizational and planning skills. Your contact Samantha Ann Metoyer BENTELER Human Resources Phone: +1 318 216-4187 Your new employer The BENTELER Group always has the answer. That's because in each of our divisions and at every one of our sites, you can benefit from the size and diversity of an international corporation with around 30,000 colleagues in nearly 30 countries. The same is true in our BENTELER Steel/Tube division. Here, we develop and produce custom, precision pipes for customers from energy production, automotive engineering, and other industrial sectors. In this division, we enable the unerring application of our products, from the concept up to process integration and thus to integration into our customers' value chains. Along with that, our diverse fields of application make sure you can be and become anything. Or, as we like to put it: BENTELER makes it happen! Benefits Share/print job offer Your Contact "I am happy to assist you and accompany you as you get started at BENTELER." Nearest Major Market: Shreveport

Posted 30+ days ago

I logo

Incog Biopharma Services Careers - QA Associate

INCOG BioPharmaFishers, IN
Working closely with the QA Supervisor, the QA Associate will be instrumental in ensuring site compliance with Regulations, ISO Standards, organizations SOPs as well as support in championing and developing organization's Quality Mindset, as well as a culture of efficiency, attention to detail, and on time delivery. The QA Associate will need to provide support with identifying operational and quality gaps. The Quality Assurance Associate will exemplify excellent interpersonal skills and be capable of developing productive, customer-centric working relationships with colleagues, internal customers, and partners. The QA Associate will demonstrate excellent written and oral communication skills with the ability to clearly and concisely articulate complex issues to a range of target audiences. The QA Associate will thrive in a team environment but will also work autonomously utilizing strong self-management and organizational skills. The QA Associate will value process owners and subject matter experts and will possess a demonstrated ability in influencing positive outcomes without direct reporting authority. Essential Job Functions: Maintain a Quality Assurance presence and provide process confirmation on the manufacturing floor. Review and approve documentation for Quality approval, including but not limited to on-floor batch record review, logbooks, work orders, procedures, etc. Collaborate with Manufacturing/Operations team and lead or provide support with investigations to resolve equipment and process related deviations. Support other QA personnel with batch record reviews, material release, etc. Prioritize and coordinate his/her time in balancing production timelines with product quality assurances. Exercise rapid decision-making in the preliminary evaluation of the scope and impact of deviating events, requirements for product segregation, and the implementation of initial corrective actions or escalate the issue to Manager for resolution. Provide support as needed in a cross-functional capacity on deviation investigative processes using root cause analysis tools, report writing, and mitigation development using risk analysis tools. Exemplify and take proactive approaches in terms of safety expectations, practice positive intervention, and enforce best practices that align to SOPs, compliance requirements, quality guidelines, and site goals. Utilize various paper and automated systems (Veeva, SCADA, BMS, CMMS, LIMS, lab instrument software, etc.) to ensure data integrity for site policies, procedures, and batch records. Use technical skills and applied statistics to analyze and track deviations and to identify sources of variability and error site processes. Ability to manage multiple projects in a fast-paced environment. Special Job Requirements: This position will support primarily first shift (7 am to 4 pm) with occasional weekend support, dependent on operations' needs. Bachelor's Degree required or equivalent; degree preferred to be in Science (Chemistry, Biology, Biochemistry, Microbiology etc.) Minimum of 2 years with experience working as Quality in a GMP Manufacturing environment, and/or as an Operator within a Pharmaceutical Manufacturing environment. Moderate knowledge of regulations and quality systems such as deviations, Non-Conformance, CAPA, etc.. Understanding of Good Documentation Practices (GDPs) and its criticality. Excellent written and verbal communication skills. General computer skills evidenced by hands-on work with computerized Operations equipment (SCADA); and reporting and data analysis software (Word, Excel, Visio, JMP, Minitab, etc.). Additional Preferences: Hands-on experience with aseptic manufacturing, inspecting finished products, and Acceptable Quality Limits (AQLs). Experience with Continuous improvement, Six Sigma, and/or Lean principles. Additional info about INCOG BioPharma Services: At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business. If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus. INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics. By submitting your resume and details, you are declaring that the information is correct and accurate.

Posted 3 weeks ago

PDI logo

QA Inspector III - 2Nd Shift

PDIOrangeburg, NY

$55,000 - $60,000 / year

Driven by a commitment to research, quality, and service, PDI provides innovative products, educational resources, training, and support to prevent infection transmission and promote health and wellness. Encompassing three areas, our Healthcare, Sani Professional and Contract manufacturing divisions, we develop, manufacture, and distribute leading edge products for North America and the world. We have several locations across the US and are looking for new Associates to join our team! POSITION PURPOSE The Quality Assurance Inspector III ensures that all products manufactured on the production floor meet required quality, regulatory, and customer standards. This role performs daily in-process inspections, testing, documentation review, and line clearances to verify compliance with GMPs and manufacturing specifications. The Inspector collaborates closely with Production and Quality teams to identify discrepancies, support sample collection and rework activities, and assist with trials and validations. As a senior-level inspector, this position also provides oversight and serves as backup to the Lead QA Inspector, ensuring appropriate coverage of inspection activities and supporting coordination of quality tasks across production lines when needed. ESSENTIAL FUNCTIONS AND BASIC DUTIES Perform daily inspection of all production lines to assure compliance to GMPs and company. Accurately and completely document all inspection information on Daily Inspection Report (DIR). Documentation required includes but is not limited to: incoming lot #, liquid lot #, item #s, fill weights, defects, etc. Ensure that all manufacturing specifications for components, labeling and product are correct, clear and complete. Inspect work areas for removal or all previous products and components. Verify readiness of work areas prior to use (Line Clearance). Monitor, sample, and inspect in-process finished product for quality by performing appropriate tests. Collect data and samples to support disposition of product. Determine final disposition of products inspected and verify information on transfer tickets. Apply appropriate disposition label to material. Identify and notify Production and Quality when discrepancies from procedures and specifications are observed. Perform AQL inspections as required. Execute Rework protocols as required. Initiate/Login LIMS and Retain Samples. Print Specifications from AS400, create shop order packages, and provide to Production, as needed. Collect samples as required by customers or Nice Pak/PDI specifications and ship samples to customers, as required by the Manufacturing Instructions. Collect stability samples. Execute Trials and Validations. Review documentation to assure accuracy prior to submittal to QA Release team. Review Master Batch Sheets. Act as Lead QA Inspector in his or her absence to complete distribution of lines and ensure proper coverage of the production floor during the appropriate shift. Identify continuous improvement opportunities and promote a quality culture. Handle assignments as requested by supervision to establish and maintain product quality. Perform any required testing as per SOPs and WIs. PERFORMANCE MEASUREMENTS First time right on review of production jackets On-time completion of all training QUALIFICATIONS EDUCATION/CERTIFICATION: Associate's Degree in a scientific, technical, or related field, or equivalent combination of education and experience. REQUIRED KNOWLEDGE: Strong understanding of Good Manufacturing Practices (GMPs), quality systems, and regulated manufacturing environments. Working knowledge of AQL inspection standards, sampling plans, and in-process quality control methods. Familiarity with batch documentation, manufacturing specifications, and component/label verification. Proficiency in Microsoft Office Suite (Word, Excel, Outlook); ability to learn and operate quality-related systems such as LIMS, ERP, and electronic documentation tools. EXPERIENCE REQUIRED: Minimum 3+ years of experience in a regulated industry (e.g., FDA, EPA, ISO), preferably in manufacturing or quality assurance roles. Demonstrated experience performing in-process quality inspections, line clearances, material disposition, and documentation review. Experience supporting trials, validations, rework activities, and sample collection for customers, retains, or stability programs. Prior exposure to continuous improvement, deviation identification, and collaboration with Production/Quality teams. SKILLS/ABILITIES: Strong ability to interpret and follow SOPs, Work Instructions, Master Batch Records, and product specifications. Excellent documentation accuracy, attention to detail, and commitment to "first-time-right" execution. Ability to conduct inspections, testing, and sampling with a high degree of consistency and objectivity. Effective communication skills with the ability to escalate discrepancies and collaborate across Production, Quality, and other cross-functional teams. Solid organizational, multitasking, and time-management skills to ensure efficient coverage of manufacturing lines. Ability to take initiative, identify improvement opportunities, and support a quality-focused culture. Leadership capability to act as Lead QA Inspector when needed and coordinate inspection coverage on the production floor. Excellent organizational and leadership skills and ability to interact with cross functional teams throughout the organization WORKING CONDITIONS Ability to lift 25 lbs. SALARY RANGE $55,000 - $60,000 annually, plus bonus PDI is pleased to offer a comprehensive and affordable benefits program to our associates, which includes: Medical & prescription drug coverage Dental / Vision plan 401(k) savings plan with company match Basic and supplemental life insurance Flexible Spending Accounts (FSAs) Short- and long-term disability benefits Health Advocacy Program / Employee Assistance Program (EAP) Many other voluntary benefit plans such as: Legal assistance, critical illness, hospital indemnity and accident coverage, discounted home/auto/rental insurance, employee discounts and pet insurance At PDI, we are also committed to helping our associates maintain a healthy and sustainable work/life balance and are proud to provide: Sick leave, generous vacation and holiday time, paid parental leave, summer hours, flex place/flex time options

Posted 30+ days ago

P logo

Associate QA Technician

Phillips Temro IndustriesEden Prairie, MN

$20 - $27 / hour

SUMMARY: Reporting to the Quality Manager or designate, the Quality Assurance Technician is responsible for ensuring company and customer quality standards are being met and non-conforming material is segregated. This is accomplished by conducting quality inspections and internal audits and communicating test and audit results. RESPONSIBILITIES AND DUTIES: Collects samples and performs assigned inspection tasks against engineering prints and specifications using various types of inspection equipment and methods. This includes performing cleanliness (Millipore) testing, MgO density inspections and using inspection equipment including, but not limited to: calipers, micrometers, height gages, thread gages, pin gages, microscopes and Keyence digital comparators. Perform routine quality audits and inspections of production work areas to ensure documented processes are being followed and product is conforming. Ensure documentation, product quantities, and work order confirmations are complete and accurate. Document, track and report out results of inspections and/or audits using pareto or Paynter charts. Supply data to support continuous process improvement and team metrics. Facilitate the Warranty and Annual Returns process per documented procedures including but not limited to: Evaluating returned product and performing initial failure analysis Performing required SAP transactions Maintaining warranty data on customer websites Communicating disposition to the customer Providing support to Sales Engineers and Accounting as needed Writing reports and presenting pareto analysis of field warranty data Load Quality Inspection plans into SAP Quality module and perform Receiving Inspection activities. Provide support to Quality Engineers and Technicians, Manufacturing Engineers, and Production, as needed including quarantine and sorting activities and dock audits. COMPETENCIES: Good verbal and written communication skills to clearly report findings to team members and customers. Excellent attention to detail and proficiency in basic measurement hand tools and print reading. Meticulous record keeping skills to document inspections, non-conformances and audit results. Excellent teamwork and interpersonal skills, including ability to work collaboratively to resolve issues. Ability to meet deadlines; accomplish work in order of priority; professionally maintain composure and effectiveness under pressure and changing conditions. Ability to learn new duties and adjust to new situations encountered on the job within a reasonable amount of time. Quality Systems ISO 9001 IATF 16949 Computer Skills MS Word Excel PowerPoint SharePoint/Teams Outlook SAP Technical Print reading GD&T Product & Process knowledge Metrology Calipers, micrometers Height gage, surface plates Electrical / Multimeter testing Thread Gages and plug gages Comparator / Microscopes MINIMUM QUALIFICATIONS: Education: Vocational Degree or High School Diploma with 3-5 years of experience in a manufacturing environment Experience: 1-3 years of experience with print reading and basic inspection equipment experience Base Pay Range: $20.00 - $27.00 Compensation Disclosure: At Phillips and Temro Industries, 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 range for this role is listed above. Your base pay will depend on your skills, education, qualifications, experience, and location. The final salary offer will be based on these criteria and may differ based on the candidate's experience and qualifications and other job-related reasons. If you have any questions about the salary range, the compensation structure, or benefits offered feel free to reach out to HR@phillipsandtemro.com Benefits Available to Full-Time Employees: Health insurance, dental, and vision (cost-share) HSA/FSA STD and LTD (company provided) Basic Life and AD&D (company provided) Voluntary Supplemental Life EAP (company provided) Voluntary Accident, Critical Illness and Hospital Indemnity 401K plan with employer match Paid time off (PTO) and holidays Volunteer hours Annual bonus based on company performance Tuition Reimbursement Safety shoe and safety glasses reimbursement

Posted 1 week ago

Johnson & Johnson logo

QA Associate III

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

Posted 1 week ago

A logo

Qa/Qc Apm-Mission Critical

Alston Construction Company, IncAtlanta, GA
About Alston Construction: Alston Construction Company is a nationwide general contractor, with more than 20 offices coast to coast. For over 35 years we have delivered on our promises to our employees, clients, and business partners. We offer extremely competitive salaries, a superb benefits package, and a great place to work! In addition to routinely receiving awards for our projects and safety performance, we have also received numerous "Best Places to Work" awards! We look for passionate construction professionals who share our core values, to include: commitment, integrity, teamwork, and respect. As our CEO, Paul Little, says "In order to be successful at Alston Construction, you must enjoy seeing success in others." If this sounds like you and what you're looking for, we'd love to hear from you! Our top tier benefits package includes medical, dental, vision, prescription safety glasses, short-term disability, long-term disability, life insurance/AD&D, HSA, health FSA, dependent daycare FSA, EAP, 401(k), Roth 401(k), After-Tax Roth In-Plan Conversion; paid vacation and sick time, paid holidays, tuition reimbursement, Tickets at Work, paid Identity Theft Protection (family coverage) and more! Job Title: QA/QC APM Job Summary: The QA/QC Assistant Project Manager supports the execution of quality assurance and quality control processes for complex, mission‑critical data center projects. This role partners with Project Management, Engineering, and Field Supervision teams to ensure construction activities meet contractual requirements, design intent, and stringent quality standards typical of high‑availability facilities. The QA/QC APM plays a key role in documentation, inspections, issue resolution, and turnover coordination to ensure systems are installed and delivered to operational readiness. Essential Duties and Responsibilities will include: Assist in developing and implementing project‑specific QA/QC plans aligned with mission‑critical requirements. Support enforcement of quality standards across all phases of construction, including structural, architectural, and MEP systems. Verify quality requirements are reflected in subcontractor scopes, work plans, and installation activities. Coordinate and participate in quality inspections, testing, and verification activities. Track, document, and manage non‑conforming work, deficiencies, and corrective actions through closure. Maintain organized QA/QC logs, inspection reports, and documentation using company systems. Support quality oversight of mechanical, electrical, plumbing, fire protection, and low‑voltage systems critical to data center operations. Assist with system verification, pre‑functional checklists, and readiness activities supporting commissioning. Collaborate with commissioning agents and project teams to support system turnover and operational testing. Support punch list development, closeout inspections, and resolution activities. Assist in the completion and review of O&M manuals, as‑built documentation, and quality records required for client turnover. Education, Experience, and Licensing/Certifications include: Bachelor's degree in Construction Management, Engineering, or related field preferred. 3-5 years of experience in construction quality, project engineering, assistant project management, or related roles. Experience on mission‑critical facilities or data center projects strongly preferred. Familiarity with MEP systems and their role in high‑availability environments preferred. Alston Construction is an Equal Opportunity Employer.

Posted 3 weeks ago

Bristol Myers Squibb logo

Manager, QA Manufacturing Operations

Bristol Myers SquibbDevens, MA

$97,440 - $118,079 / year

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. PRINCIPAL OBJECTIVE OF THE POSITION: Support Devens site through review and approval of investigations and change controls. Provide Quality oversight and support for Technology Transfer, Automation, Cell Bank Disposition, Validation, Manufacturing Science and Technology, Master Data and Site Engineering programs. Assure the quality of manufactured products are in compliance with all applicable regulations and guidelines. May assist in preparing for and hosting of regulatory audits. Major Duties and Responsibilities Supports and provides quality oversight to technical transfer sub-teams and the review and approval of technology transfer documentation Leads and provides quality oversight to automation forums. Provide review and approval of automation change management. Assures consistent, effective use of the site change control system for all change requests. Ensures supporting documentation and change deliverables meet external regulatory and internal Global BMS guidelines and requirements. Leads the cell bank disposition program and program management. Track and review deliverables for disposition and re-evaluation. Support and provides quality oversight to projects and incoming transfers for cell banking operations. Provide quality oversight, review and approve Master Data for SAP and Syncade in support of tech transfer and projects. Provide quality oversight, review and approve Maximo work orders, OOTs, extensions for PMs and Cals. May support projects interfacing with Site Engineering. Provides quality support and oversight for Manufacturing Science and Technology and Validation protocols and reports and periodic assessments. Provides quality support to Devens Site through quality review and approval of deviations or change controls. Participates as requested in the response team for audits and inspections by world health authorities. Receives little supervision and identifies and reports and discrepancies from normal practices or procedures to management, recommending and implementing corrective actions. Makes sound decisions by exercising judgment within generally defined practices and policies and applies appropriate notification to management as appropriate Drives opportunities for continuous improvement through project leadership, Quality systems program ownership, and group engagement. Represents QA in cross-functional meetings. Provides training on QA-owned procedures. May provide guidance to less experienced staff. May have direct supervision of non-exempt and/or exempt staff. Knowledge and Skill Knowledge of biotech bulk and finished product manufacturing, analytical testing is highly desirable. Extensive knowledge of US and EU cGMP regulations and guidance. Knowledge of Quality Risk Management principles preferred. Knowledge of electronic systems including any of the following: SAP, LIMS, Infinity (Veeva Vault), LES, Maximo, Vault and Syncade desirable. Experience working in a team-based environment with a diverse group of people. Excellent writing and oral communication skills are required. Qualifications Knowledge of science generally attained through studies resulting in a B.S. in science, engineering, biochemistry or related discipline, or its equivalent is preferred. A minimum of 6 years of relevant experience in a regulated environment with at least 4 years focused on product quality. Contacts Quality Operations- Site Support personnel may have business needs to interact with any employee at any level of the Devens Facility with daily interactions with other Quality staff, Site Engineering, Operational Engineering, Supply Chain, Automation, Technical Services and Manufacturing staff, as they investigate and conclude documentation on change management and deviations. There may be contact with outside vendors and representatives from health authorities / regulatory agencies. Working Conditions Work in a cGMP manufacturing environment following techniques which require one to maintain a high attention to detail. Properly use Personal Protective Equipment (PPE), gowning for restricted areas, handling chemicals, and work in a general office environment. DECISION MAKING: Take action, final decision, recommend Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Supervision Received Receives little supervision and identifies and reports any discrepancies from normal practices or procedures to management, recommending and implementing corrective actions. Supervision Exercised Not expected to supervise Full-Time Employees. May manage contract staff. #BMSBL #LI-Onsite 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. Compensation Overview: Devens- MA - US: $97,440 - $118,079 The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. 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 https://careers.bms.com/life-at-bms/ . Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment. Our benefits include: Health Coverage: Medical, pharmacy, dental, and vision care. Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP). Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support. Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day. All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown. Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program. 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. Supporting People with Disabilities 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. Candidate Rights 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/ Data Protection We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection . Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at TAEnablement@bms.com. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley. R1598315 : Manager, QA Manufacturing Operations

Posted 1 week ago

Aerovironment logo

Software QA Automation Engineer III

AerovironmentMelbourne, FL

$81,481 - $115,500 / year

Worker Type Regular Job Description Summary The Software QA Automation Engineer III designs automated solutions to perform applicable software validations. In this role, one regularly collaborates with our development team but also operates with a large degree of autonomy. Position Responsibilities Participates in the design, expansion and maintenance of automated testing suite Defines and plan scope, resource needs, benchmarks and goals of manual & automation work Defines and implement QA practices, procedures, standards and reporting Identifies project risks, quantify risk/benefit relationships and provide alternative solutions as well as risk mitigation Designs test plans, scenarios and cases to exercise new functionality & identify breaking issues Analyzes, designs, programs, debugs, and modifies software enhancements and/or new products used in local, networked, cloud-based or Internet-related computer programs Partners with resources as needed to validate software with project timeline Mentors less experienced team members on QA/QC concepts, methodologies and best practices Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors Other duties as assigned Basic Qualifications (Required Skills & Experience) Bachelor's degree in related discipline is required or equivalent combination of education, training, and experience Minimum 5 - 8 years of relevant experience Experienced in Software QA automation Experienced in building and optimizing automation frameworks Experienced performing code reviews and mentoring team members on automation concepts and best practices Other Qualifications & Desired Competencies Champions quality by forging influential relationships across QA, Development, Product, and DevOps Demonstrates strong debugging / problem resolution skills, and competency in multitasking and handling multiple time critical issues / projects simultaneously Demonstrates passion to continuously improve and execute tests for a faster and higher quality result Is an experienced professional with a full understanding of area of specialization; resolves a wide range of issues in creative ways Demonstrates good judgment in selecting methods and techniques for obtaining solutions Able to excel in a fast-paced, deadline-driven environment, where small teams share a broad variety of duties Displays strong initiative and drive to accomplish goals and meet company objectives Takes ownership and responsibility for current and past work products Is committed to learning from mistakes and driven to improve and enhance performance of oneself, others, and the company Has effective interpersonal and communication skills Focuses on teamwork, collaboration and puts the success of the team above one's own interests Physical Demands Ability to work in an office and R&D environment (Constant) Required to sit and stand for long periods, talk, hear, and use hands and fingers to operate a computer and telephone keyboard Occasionally may be required to travel within the Continental U.S. (20%) The salary range for this role is: $81,481 - $115,500 AeroVironment considers several factors when extending an offer, including but not limited to, the location, the role and associated responsibilities, a candidate's work experience, education/training, and key skills. ITAR Requirement: This position requires access to information that is subject to compliance with the International Traffic Arms Regulations ("ITAR") and/or the Export Administration Regulations ("EAR"). In order to comply with the requirements of the ITAR and/or the EAR, applicants must qualify as a U.S. person under the ITAR and the EAR, or a person to be approved for an export license by the governing agency whose technology comes under its jurisdiction. Please understand that any job offer that requires approval of an export license will be conditional on AeroVironment's determination that it will be able to obtain an export license in a time frame consistent with AeroVironment's business requirements. A "U.S. person" according to the ITAR definition is a U.S. citizen, U.S. lawful permanent resident (green card holder), or protected individual such as a refugee or asylee. See 22 CFR § 120.15. Some positions will require current U.S. Citizenship due to contract requirements. Benefits: AV offers an excellent benefits package including medical, dental vision, 401K with company matching, a 9/80 work schedule and a paid holiday shutdown. For more information about our company benefit offerings please visit: http://www.avinc.com/myavbenefits . We also encourage you to review our company website at http://www.avinc.com to learn more about us. Principals only need apply. NO agencies please. Who We Are Based in California, AeroVironment (AVAV) is a global leader in unmanned aircraft systems (UAS) and tactical missile systems. Founded in 1971 by celebrated physicist and engineer, Dr. Paul MacCready, we've been at the leading edge of technical innovation for more than 45 years. Be a part of the team that developed the world's most widely used military drones and created the first submarine-launched reconnaissance drone, and has seven innovative vehicles that are part of the Smithsonian Institution's permanent collection in Washington, DC. Join us today in developing the next generation of small UAS and tactical missile systems that will deliver more actionable intelligence to our customers so they can proceed with certainty - and succeed. What We Do Building on a history of technological innovation, AeroVironment designs, develops, produces, and supports an advanced portfolio of unmanned aircraft systems (UAS) and tactical missile systems. Agencies of the U.S. Department of Defense and allied military services use the company's hand-launched UAS to provide situational awareness to tactical operating units through real-time, airborne reconnaissance, surveillance, and target acquisition. We are proud to be an EEO/AA Equal Opportunity Employer, including disability/veterans. AeroVironment, Inc. is an Equal Employment Opportunity (EEO) employer and welcomes all qualified applicants. Qualified applicants will receive fair and impartial consideration without regard to race, sex, color, religion, national origin, age, disability, protected veteran status, genetic data, sexual orientation, gender identity or other legally protected status. ITAR U.S. Citizen, U.S. Permanent Resident (Green Card holder), asylee/refugee status as defined by 8 U.S.C. 1324b(a)(3) or a person approved for an export license from the appropriate governing agency.

Posted 30+ days ago

A logo

QA Technician

Al Copeland InvestmentsTheodore, AL
Description Diversified Foods and Seasonings is a leading food manufacturing company. We pride ourselves in our commitment to providing our customers with the finest, convenient specialty food products and ingredients. With over 25 years of experience as an industry leader, Diversified is comprised of fully automated USDA-inspected kettle cooking operations. We are all about quality food and customer satisfaction. We are currently seeking a QA Technician at our Diversified Foods and Seasonings facility in Theodore, AL The QA Technician's responsibilities are to assist the QA Manager and QA Supervisor with executing the company's and plant's vision and mission by assuring that all products meet regulatory, customer, and company specifications. Responsibilities: Conduct pre-operational and post-operational SOP (Standard Operating Procedure) and SSOP (Sanitation Standard Operating Procedure), HACCP (Hazard Analysis Critical Control Point), and GMP (Good Manufacturing Practices inspections and document the results. Conduct raw, in-process, and finished product testing (chemical and microbiological), along with product review of products against customer and company specifications and documenting the results. Upper management of product failures and place the product on hold as well as release the product upon final disposition by management. Issue corrective action reports for SOP/ SSOP/HACCP deviations and document follow-up. Train employees and all other duties as required. Required Qualifications: HS Diploma or equivalent Basic Computer Skills Good communication skills Basic understanding of lab procedures and microbiology Basic math and intermediate reading skills Able to identify differences in colors Able to lift over 50 pounds and must have a good, solid back and knees with full mobility. Preferred Qualifications: Associate's or Bachelor's degree in a science-related field Previous QA or food manufacturing experience Benefits: 401(k) Dental Insurance Health insurance Paid time off Vision insurance

Posted 2 days ago

KITE PHARMA, INC. logo

QA Specialist III

KITE PHARMA, INC.Santa Monica, CA

$107,185 - $138,710 / year

We're here for one reason and one reason only - to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. We've made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're not finished yet. Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Kite and help create more tomorrows. Job Description We are seeking a highly motivated individual contributor to join us as a QA Specialist III within External Quality embedded within Kite's External Quality Organization. The QA Specialist III will report to the Quality Director, External Quality. Scope of the External Quality group includes quality oversight of contracted service providers such as development and manufacturing organizations(CMO/CDMO), contract testing labs (CTLs) and quality support for Strategic Partnerships spanning clinical and commercial operations within the cell therapy space. The QA Specialist III will have opportunities to work and share knowledge with partners across Kite's Global Technical Operations (e.g. Quality Control, Analytical Development, Process Development, Quality, Manufacturing, Supply Chain, and Regulatory) as well as international partners. The ideal candidate will have strong technical skills (knowledge of one or more of the following: cell therapy, bioassays, viral vector, and testing operations), Quality and Compliance background (Biologics, Drug, regulation), and understanding of the drug development lifecycle. This position will be based at Kite's headquarters in Santa Monica, CA. Responsibilities of the QA Specialist III include: Quality support of one or more CMO/CDMO and execution of all day-to-day quality operational responsibilities. Authoring, review and/or approval of GxP records and documents (both internal and external) including but not limited to: master and executed production batch records, investigations, corrective actions, change controls, protocols and reports, annual product quality reviews, IND/BLA/MAA CMC modules, Quality Agreements. Compilation of critical material and product disposition packages. Project management of disposition deliverables (e.g. investigations, batch records) ensuring timely critical material and/or product supply. Perform disposition (release) of product from CMOs. Ownership of critical issues or risks that emerge and provide mitigation recommendations to the team; monitoring performance related to performance of Kite's CMOs. Assist, gather and analyze information to support External Supply Quarterly Management Review, provide mitigation plans for issues and risks. Supporting agency inspections as quality focused topic subject matter expert for all inquiries relating to external operations. Up to 10% travel (domestic) Basic Qualifications: Master's Degree and 3+ years' experience in GMP environment related field OR Bachelor's Degree and 5+ years' experience in GMP environment related field Preferred Qualifications: Working with or at contract manufacturing or testing organizations or supporting partnerships. Diplomacy skills and ability to assess performance and proactively identify and mitigate risks Experience with collaborating in a cross-functional working model with support from fully-and partially dedicated resources; ability to manage through influence. Experience with direct FDA interaction (or other regulatory agencies) Experience writing, evaluating and closing investigations, CAPAs and change control records. Must be able to work on multiple projects simultaneously and demonstrate organizational, prioritization, and time management proficiencies Excellent oral and written communication skills Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description. Previous experience in Quality Control, Quality Assurance or Analytical Science People Leader Accountabilities: Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams. Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose. Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem. The salary range for this position is: $107,185.00 - $138,710.00. Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*. For additional benefits information, visit: https://www.gilead.com/careers/compensation-benefits-and-wellbeing Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans. Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma. For jobs in the United States: Kite Pharma is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance. For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT Kite Pharma will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law. Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team. Kite Pharma provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion. For Current Kite Pharma Employees and Contractors: Please apply via the Internal Career Opportunities portal in Workday.

Posted 2 weeks ago

Inotiv logo

QA Auditor

InotivGaithersburg, MD

$69,700 - $85,000 / year

Demonstrate Inotiv Core Values Follow all Standard Operating Procedures (SOPs) and other applicable laboratory or company policies and procedures Maintain confidential information General Interact with clients, other employees, and the community in a professional manner Support and participate in company initiatives as directed Maintain thorough knowledge of facility SOPs, policies, study protocols, etc. Adhere to all safety regulations and procedures Provide assistance or support to other Inotiv QA team members as necessary Perform other duties as assigned Specific Demonstrate solid understanding of application and interpretation of FDA and EPA GLPs as well as applicable international regulations Keep abreast of new rules, guidance and industry standards in order to improve laboratory compliance Conduct audits of designated studies and facilities to assess compliance with protocols, SOPs, methods and relevant regulations (audits may include direct observation of study conduct and/or laboratory processes, review of protocols, study data and reports, or review of facility records and SOPs as well as subcontractor contributions) Prepare an audit report and submit all findings to Study Director/Principal Investigator and management promptly Issue accurate quality assurance statements for inclusion in final reports Become familiar with electronic data collection systems used in data generation, including proper use, reporting, audit trails, security/Part 11 compliance, data correction, and QC Input and/or update information in the Master Schedule program as required by GLP regulations and SOPs Independently conduct process or facility inspections Assist with audits and inspections conducted by Sponsors and regulatory agencies, as requested Conduct quality training for new hires and other employees, as assigned. Participate in or lead subcontractor and/or vendor evaluations Serve as a resource to represent the QA team on regulatory topics (e.g, at study initiation meetings), as requested Participate in departmental business, process or general regulatory projects, as assigned Perform other duties as assigned. Base salary for this position ranges from $69,700 to $85,000 and will be based on a candidate's skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data.Education and Experience B.S. in chemistry or life sciences or Bachelor's degree or higher in a related field and Two to four years of experience in a GLP or similarly regulated environment preferably with 1 or more years of auditing experience, or Equivalent combination of education and regulatory, quality, compliance and/or industry experience. Skills and Abilities Excellent written and verbal communication and interpersonal skills with ability to work with personnel at all levels of the organization Good organizational skills and detail oriented A working knowledge and awareness of general laboratory procedures Ability to comprehend and apply applicable government regulations Displays versatility and accuracy when performing various tasks, some of which may be difficult and/or non-routine Ability to work independently and follow written instructions Proficient in the use of computer software applications as needed to effectively conduct QA duties (e.g., Word, Outlook, Excel, SharePoint) Ability to comprehend and apply applicable government regulations Analytical thinker with the ability to understand problems, determine root cause and recommend appropriate solutions Experience with quality systems management and enterprise quality management software preferred Performance Requirements General Ability to read, write, speak and understand oral and written instructions Available for occasional business travel Physical Activity Requires moderate physical activity including: Standing and/or walking for four (4) or more hours per day Repetitive movement of hands and fingers Reaching and heavy lifting (up to 50lbs) Prolonged periods of sitting and computer work May require transit between buildings or sites as well as walking over rough terrain Base salary for this position ranges from $69,700 to $85,000 and will be based on a candidate's skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. This position could be offered at different levels for candidates who qualify with a combination of advanced levels of education and/or years of experience. The salary range will adjust along with the level of the role to match the person's relevant experience and/or education level. Inotiv is a growing contemporary drug discovery and development company where we "Play to Win" in an industry rich with opportunity. Together, we face challenges and together we win in the delivery of world-class drug discovery and development solutions that impact the health and well-being of people all over the world. There's an opportunity for everyone at all phases of a career, each individual's unique skill set has an impact on the work we conduct. If you have the talent and desire to impact the quality of people's lives, we have the career opportunities to make it happen. Join us in embracing research and science to impact the health and well-being of people all over the world. Salary will be commensurate with experience and responsibilities. Benefits include health and dental coverage, short- and long-term disability, paid time off, paid parental leave, 401K, and more! Inotiv is an Equal Opportunity Employer. It is our policy to provide a fair and equal employment opportunity to all persons, regardless of age, race, color, religion, sex, gender, gender identity, gender expression, sexual orientation, genetic information, disability, national origin, veteran status, or any other basis prohibited by law. This policy governs all aspects of employment, including selection, job assignment, compensation, discipline, termination and access to benefits and training.

Posted 1 week ago

Ivy Rehab logo

Patient Engagement Center QA Manager

Ivy RehabHouston, TX
State of Location: Texas Position Summary: At Ivy Rehab, we're "All About the People"! As a Call Center / Patient Engagement Center QA Manager, you will play a crucial role in our mission to help enable people to live their lives to the fullest. Join Ivy Rehab's dedicated team where you're not just an employee, but a valued teammate! Together, we provide world-class care in physical therapy, occupational therapy, speech therapy, and applied behavior analysis (ABA) services. Our culture promotes authenticity, inclusion, growth, community, and a passion for exceptional care for every patient. Job Description: OUR VALUES: One Ivy- Love what you do- Do the right thing- I belong- GSD (Get stuff done) - Grow- Serve others The Patient Engagement Center QA Manager will develop and lead the Quality Assurance (QA) program for our Patient Engagement Center (PEC) by evaluating patient interactions, collecting and analyzing data to improve processes and protocols within the contact center, finding coaching opportunities, and helping Patient Engagement Advocates improve their skills. In this role, the PEC QA Manager will be responsible for ensuring that PEC team members are properly and effectively handling a variety of interactions, ranging from scheduling/changing new patient appointments, to general questions, to complaints. Over time, the PEC will also handle other interaction channels, such as outbound, chat, email. The PEC QA Manager will ensure that team members can resolve issues quickly and effectively, de-escalate challenging situations, and provide an exceptional patient experience. Your responsibilities will include: Design and develop our quality assurance program by setting clear and measurable standards that align with the PEC's goals and ensure a consistent and quality approach to handling patient interactions Regularly monitor and conduct evaluations of interactions to assess the quality of service and identify strengths and areas for improvement in Advocate performance Provide in-the-moment coaching to Advocates to improve their performance as measured against KPIs Lead the "nesting" program when Advocates graduate training and begin handling interactions Collaborate with other Ivy departments to ensure process alignment among the PEC, front office, and clinic teams to meet quality standards for all departments involved in patient interactions Observe daily operations of the contact center and lead interaction quality calibrations to identify skill gaps and necessary training program improvements Evolve QA program (materials, modalities, processes) with growth of contact center Develop strategies to improve PEC KPIs and create reporting structure to share performance trends, areas of concern, and opportunities for improvement with Advocates and PEC management To excel in this role, you should possess: Undergraduate degree and minimum 3-5 years quality assurance experience in a contact center environment Empathy and coaching abilities to provide feedback that is not only constructive but also supportive Excellent problem-solving and analytical skills to not only identify issues but offer innovative solutions Healthcare/physical therapy experience a plus Knowledge of customer service best practices Detail-oriented, self-reliant, and process-driven mindset Strong communication (verbal and written), interpersonal, and conflict resolution skills Ability to provide leadership to team members in a fast-paced and stressful work environment Must be technically savvy, with demonstrated experience working with multiple systems and apps Why choose Ivy? Best Employer: A prestigious honor to be recognized by Modern Healthcare, signifying excellence in our industry and providing an outstanding workplace culture. Exceeding Expectations: Deliver best-in-class care and witness exceptional patient outcomes. Incentives Galore: Eligibility for full benefits package beginning within your first month of employment. Generous PTO (Paid Time Off) plans and paid holidays. Exceptional Partnerships: Collaborate with leaders like Hospital for Special Surgery (HSS) and educational partners for continuous learning. Empowering Values: Live by values that prioritize teamwork, growth, and serving others #LI-remote #LI-ST1 We are an equal opportunity employer, committed to diversity and inclusion in all aspects of the recruiting and employment process. Actual salaries depend on a variety of factors, including experience, specialty, education, and organizational need. Any listed salary range or contractual rate does not include bonuses/incentive, differential pay, or other forms of compensation or benefits. ivyrehab.com

Posted 5 days ago

Lockheed Martin Corporation logo

QA Engineer Staff- Ocala, FL

Lockheed Martin CorporationOcala, FL
Description:Quality Engineer Staff Description: You will be the Quality Engineer Staff for the Missiles & Fire Control (MFC) team. Our team is responsible for ensuring the quality of manufactured, repaired, and procured products meet or exceed design and process requirements. What You Will Be Doing As the Quality Engineer Staff you will be responsible for providing quality engineering expertise to support the program's quality objectives, developing and reviewing quality standards, methods, and procedures, and driving continuous improvement across the product lifecycle. Your responsibilities will include, but are not limited to: Reviewing documentation related to internal and external manufacturing processes Updating planning and work instructions Analyzing quality data on yields, rework, scrap, and non conformances Leading program parts review and corrective action meetings Ensures corrective/ preventive measures meet acceptable reliability standards and/or are compliant with requirements Performing assessments and audits on processes and procedures to ensure compliance Performs technical evaluations including product requirements, specifications, models/designs, drawings and procedures Collaborates with program management, engineering, manufacturing, supply chain and customers on quality related issues to ensure quality standards are in place Engages in product failure investigations, and material review board decisions Evaluates quality systems for deficiency identification and correction Why Join Us The ideal candidate is a collaborative, detail oriented engineer who thrives in a fast paced environment and is passionate about delivering flawless products to customers. This role offers direct impact on mission critical programs, exposure to cutting edge aerospace technology, and the opportunity to shape quality practices that support national security. We are committed to supporting your work life balance and overall well being, offering flexible scheduling options. Learn more about Lockheed Martin's comprehensive benefits package here. Further Information About This Opportunity This position is in Ocala, Florida. Discover more about our Ocala, Florida location. MUST BE A U.S. CITIZEN - This position is located at a facility that requires special access. The selected candidate must be able to obtain a secret clearance. Basic Qualifications: Must be a U.S. Citizen Must have the ability to obtain a security clearance Bachelor's level degree or higher in STEM or equivalent experience Prior Quality Engineering experience developing and reviewing quality standards, methods, work instructions and procedures for the inspection of manufactured and procured products. Demonstrated experience applying AS9100 / ISO 9001 quality management system requirements Hands on experience dealing with inspection of hardware and rework / repair of hardware Proven ability to lead root cause and corrective action efforts using standard methodologies (RCCA, A3, 5-Why, Fishbone) Experience with nonconformance management, corrective action systems, and audit support Working knowledge of statistical analysis tools (SPC, trend analysis, capability studies) Ability to interpret and apply engineering drawings, specifications, and contractual requirements Experience working in cross-functional environments to resolve quality issues and drive closure Strong written and verbal communication skills, including preparation of technical documentation and leadership briefings Effective interpersonal skills, including team building and collaboration. Ability to work independently with limited direction while managing competing priorities Desired Skills: Bachelor's level degree or higher in STEM Experience in aerospace, defense, or other highly regulated manufacturing environments Demonstrated experience serving as a Quality Subject Matter Expert (SME) Experience mentoring or providing technical guidance to junior Quality Engineers Experience supporting program execution, production operations, or system deployments Experience with digital manufacturing and enterprise systems (e.g., Apriso, SAP, Windchill) Demonstrated ability to drive continuous improvement initiatives, risk reduction, or cost savings Experience with performing First Article Inspections to AS9102 requirements. Experience working with Government customers and suppliers in a sustainment environment. Knowledge of Lean / Six Sigma tools and continuous improvement methodologies Quality certifications such as ASQ CQE, CQA, or Six Sigma Green/Black Belt Ability to influence quality decisions at the program, site, or enterprise level Security Clearance Statement: This position requires a government security clearance, you must be a US Citizen for consideration. Clearance Level: Secret Other Important Information You Should Know Expression of Interest: By applying to this job, you are expressing interest in this position and could be considered for other career opportunities where similar skills and requirements have been identified as a match. Should this match be identified you may be contacted for this and future openings. Ability to Work Remotely: Onsite Full-time: The work associated with this position will be performed onsite at a designated Lockheed Martin facility. Work Schedules: Lockheed Martin supports a variety of alternate work schedules that provide additional flexibility to our employees. Schedules range from standard 40 hours over a five day work week while others may be condensed. These condensed schedules provide employees with additional time away from the office and are in addition to our Paid Time off benefits. Schedule for this Position: 4x10 hour day, 3 days off per week Lockheed Martin is an equal opportunity employer. Qualified candidates will be considered without regard to legally protected characteristics. The application window will close in 90 days; applicants are encouraged to apply within 5 - 30 days of the requisition posting date in order to receive optimal consideration. Join us at Lockheed Martin, where your mission is ours. Our customers tackle the hardest missions. Those that demand extraordinary amounts of courage, resilience and precision. They're dangerous. Critical. Sometimes they even provide an opportunity to change the world and save lives. Those are the missions we care about. As a leading technology innovation company, Lockheed Martin's vast team works with partners around the world to bring proven performance to our customers' toughest challenges. Lockheed Martin has employees based in many states throughout the U.S., and Internationally, with business locations in many nations and territories. Experience Level: Experienced Professional Business Unit: MISSILES AND FIRE CONTROL Relocation Available: Possible Career Area: QA/Test and Inspection Type: Full-Time Shift: First

Posted 4 days ago

Bose logo

Software QA Engineer - Embedded Audio Systems

BoseUS, , MA

$75,200 - $103,400 / year

At Bose Corporation, we believe sound is the most powerful force on earth - and for over 60 years, we have been a company built on innovation, excellence, and independence. Privately owned, fiercely customer-focused, and driven by our values, we continue to lead industries and transform lives through sound. Today, Bose Corporation is entering an exciting new era. Across multiple global Business Units and Global Functions, we are shaping the future of audio technology, automotive, luxury, and premium experiences. We invite you to join us in this transformation. Job Description About the Role As an entry-level SQA Engineer, you will be part of the embedded software QA team responsible for validating the performance and reliability of our next-generation headphones and speakers. You will engage in rigorous testing and troubleshooting of embedded systems, working closely with development teams to identify issues, support defect resolution, and contribute to the overall improvement of product quality and user experience. What You'll Do Execute focused test plans for embedded consumer audio products. Validate core software functionality using Black-box and white-box techniques. Perform regression testing to ensure feature stability and defect resolution. Use tools such as TestRail to manage test cases and track test execution. Collaborate with QA leads and developers to report, investigate, document, triage, and validate resolutions of issues. Assist with device setup and maintenance of lab test environments. Build foundational knowledge of Bluetooth technologies and embedded system testing. Qualifications Bachelor's degree in Computer Science, Computer Engineering, Electrical Engineering, or related field. Strong analytical and problem-solving skills with great attention to detail. Effective written and verbal communication abilities. Familiarity with embedded systems, Bluetooth fundamentals, or consumer hardware is a plus. Exposure to test tools such as TestRail, Wireshark, or BlueSuite is beneficial. Experience in Agile or Scrum environments is a plus. Scripting or automation experience is not required, but is considered a bonus. Being currently authorized to work in the U.S. is a precondition of employment for this position. Must be willing to work in a hybrid work environment. No relocation assistance is available. At Bose, you're inspired to be and do your best and are rewarded for your unique talents! Our compensation is thoughtfully tailored to your skills, experience, education, and location, and goes beyond base salary. The hiring range for this position in the primary work location of Framingham, Massachusetts is: $75,200-$103,400.The hiring range for other Bose work locations may vary. In addition to competitive base pay we offer rewards including bonus programs, comprehensive health and welfare benefits, a 401(k) plan, plus exclusive perks designed to support your wellbeing, and a generous employee discount where you can immerse yourself in our products and experiences. We are a proudly independent company-driven by purpose, guided by our values, and united by a belief in the power of sound. As the world leader in audio experiences, we're creating what's next-pushing boundaries and delivering transformative sound experiences for people everywhere. Join us and make your next career move a mic-drop. Let's Make Waves. Bose is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status, or any other legally protected characteristics. The EEOC's "Know Your Rights: Workplace discrimination is illegal" Poster is available here: https://www.eeoc.gov/sites/default/files/2023-06/22-088_EEOC_KnowYourRights6.12ScreenRdr.pdf . Bose is committed to providing reasonable accommodations to individuals with disabilities. If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to applicant_disability_accommodationrequest@bose.com. Please include "Application Accommodation Request" in the subject of the email. Our goal is to create an atmosphere where every candidate feels supported and empowered in the interviewing process. Diversity and inclusion are integral to our success, and we believe that providing reasonable accommodation is not only a legal obligation but also a fundamental aspect of our commitment to being an employer of choice. We recognize that individuals may have different needs and requirements based on their abilities, and we provide reasonable accommodations to ensure ideal conditions are met during the application process.

Posted 4 days ago

A logo

QA Production Inspector - 1St Shift - $19.00/Hr - $19.50/Hr

Applied Medical Technology, Inc.Brecksville, OH

$19 - $20 / hour

Description 1st Shift - $19.00/hr starting, 19.50/hr fully trained! Since 1985, our core business has been enteral device product development, design, manufacturing, and engineering in a state-of-the-art facility near Cleveland, Ohio. AMT's steady growth consistently creates job opportunities in Northeast Ohio. We are always searching for new talent and would love for you to join our team! We strive to keep the small company feeling while still reaching users all over the globe. Schedule: Monday-Friday 7:00am - 3:30pm Position Summary: The Quality Inspector is responsible for quality control. They are also responsible to determine if assembled or packaged components/products meet predetermined specifications. Duties and Responsibilities: This list is not comprehensive but meant to represent the most common or important duties of the Quality Inspector position. Other duties are required and/or assigned Make sure all parts and orders are in compliance with assembly instructions to specific quality guidelines Make sure all part numbers, lot numbers, expiration dates, etc. and all paperwork correspond with the order request Use of manual and semiautomatic fixtures Quality inspection of assembled or packaged components Maintain quality and efficiency standards Complete paperwork accurately and legibly Cross-functional training required Follow instructions and procedures accurately and precisely Data entry Other duties as assigned. Requirements Minimum Qualifications: HS Diploma or equivalent Language Skills: Ability to read, analyze and interpret engineering drawings, general business periodicals, technical procedures, or governmental regulations. Mathematical Skills: Ability to apply concepts of basic math. Reasoning Ability: Ability to solve practical problems and interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Essential Job Functions: Critical features of this job are described below. They may be subject to change at any time due to reasonable accommodation or other reasons. Mental: Must be able to effectively communicate with others; complete and understand analysis of numbers; read, analyze and interpret written materials; compliance with company policies; respond appropriately to feedback to make improvements; maintain positive working relationships; troubleshoot and solve problems. Physical: Must be able to hear and verbally communicate. Must be able to lift up to 25 lbs, sit stand and walk for hours at a time. Moderate noise level and limited exposure to physical risk. Ability to handle and manipulate small components. Ability to see items 1/32" or smaller, good eye-hand coordination, ability to handle repetitive tasks. Knowledge, Skills, and Abilities Required: Ability to establish priorities, work independently with minimal supervision, and facilitate teamwork. Equipment Used: Pneumatic gauges, pin gauges, digital calipers, computers, barcode scanners Special/ Additional Requirements: Persons in this position may be required to pass a drug, alcohol, and/or criminal background check. AMT is Equal Opportunity/Affirmative Action Employer. Benefits: Insurance: AMT offers major medical, dental, and vision insurance at the first of the month following 30 days of service. Other Benefits: AMT offers several other voluntary benefits including hospital indemnity, critical illness, term life insurance & long term disability (company paid), among others. 401k: AMT matches 100% of your contribution, up to 3% of your salary. Paid Time Off (PTO): In addition to nine paid holidays, AMT provides employees with paid time off (determined by length of service), starting on day one Other Exciting Perks! Tuition Reimbursement Employee Assistance Program Annual Employee Appreciation Picnic! No Mandatory Overtime! Employee Referral Bonus Program Work Conditions: Clean work environment that is located in an air conditioned and temperature controlled environment. You are also allowed to have in headphones and listen to music as you work!

Posted 30+ days ago

T logo

Lead QA Engineer

Tek Leaders Incalbany, OH
Role Name: Quality Engineer /Lead SDET/Lead QA Location: Cincinnati, OH Rate : Only on W2 Role Description: We are looking for a detail-oriented and motivated Quality Engineer with a strong background in the Retail domain to drive our testing strategy and automate integrated applications. This role demands a hands-on technical expert who can align testing with fast-paced retail transformation initiatives. Must Have Skillset: Expert-level automation experience in: Selenium for UI validation Playwright for modern and responsive web interfaces. Karate Framework for REST and SOAP API validation testing (using tools such as Postman, SoapUI, or Rest Assured). Experience testing in Retail Point-of-Sale (POS) environments or similar retail systems. Git, Jenkins, CI/CD pipelines, and integration with test management tools (e.g., QMetry, JIRA, Zephyr). BDD/TDD, data-driven testing, and mocking service layers. coding/scripting skills in Java, JavaScript, or Python. Key Responsibilities: Perform manual and automated testing to ensure the quality of products, systems, or applications Work closely with developers and product teams to understand product requirements and design test cases based on specifications Understand mobile application testing methodologies, tools, and best practices Design and execute test plans, test cases, and test scripts for mobile applications Performing functional, regression, performance, and usability testing Develop and execute detailed test plans, test cases, and test scripts. - Identify, report, and track software defects, and ensure proper resolution. Test APIs (REST/SOAP) to ensure the integration and communication between different systems are working as expected Use SQL to query databases and validate data integrity, correctness, and consistency across different environments Perform regression testing to ensure that new features or changes don’t negatively impact existing functionality Collaborate with the development team to resolve quality issues in a timely manner Participate in code reviews and provide feedback on software design, functionality, and performance Contribute to continuous improvement of testing processes and practices Maintain detailed records of test results, defects, and troubleshooting Participate in sprint planning, daily stand-ups, and retrospective meetings Nice to Have Experiences/Skills: Experience with cloud-hosted microservices and integration testing across retail platforms ISTQB, Certified Agile Tester, or similar certifications

Posted 30+ days ago

A logo

Software QA Engineer: 26-00252

Akraya Inc.Fremont, CA

$48 - $52 / hour

Primary Skills: Python-Expert, Selenium-Advanced, Playwright-Advanced, REST APIs-Intermediate, MySQL-Intermediate Contract Type: W2 and C2C Location: Fremont, CA (100% Onsite - 5 days in office) Duration: 6+ months (Possible extension) Pay Range: $48 - $52 per hour on C2C or W2 Job Summary: We are seeking a Senior Software QA Engineer to join our team. The role demands a high priority commitment to ensure quality assurance across our projects, utilizing a tech stack that includes Python, Selenium, Playwright, REST APIs, and MySQL databases. The ideal candidate will bring a blend of technical prowess in our specific stack alongside a problem-solving mindset to enhance our software quality effectively. Key Responsibilities: Design, develop, and execute automated tests using Python, Selenium, and Playwright. Ensure the compatibility of applications across multiple platforms and devices through rigorous testing. Assess and improve existing testing frameworks and methodologies to enhance efficiency and effectiveness. Collaborate with the development team to identify and fix bugs within the software. Maintain documentation of test cases, outcomes, and bugs detected for future reference. Must-Have Skills: Proficient in Python programming and testing frameworks like Selenium and Playwright. Strong understanding of REST APIs and experience with MySQL. Demonstrated ability to work effectively in an onsite, team-oriented environment. Industry Experience: Previous experience working in a QA role within the software development domain is essential, with a preference for candidates who have a solid understanding of the technical requirements listed. ABOUT AKRAYA Akraya is an award-winning IT staffing firm consistently recognized for our commitment to excellence and a thriving work environment. Most recently, we were recognized Inc's Best Workplaces 2024 and Silicon Valley's Best Places to Work by the San Francisco Business Journal (2024) and Glassdoor's Best Places to Work (2023 & 2022)! Industry Leaders in IT Staffing As staffing solutions providers for Fortune 100 companies, Akraya's industry recognitions solidify our leadership position in the IT staffing space. We don't just connect you with great jobs, we connect you with a workplace that inspires! Join Akraya Today! Let us lead you to your dream career and experience the Akraya difference. Browse our open positions and join our team!

Posted 2 weeks ago

GTT logo

QA Specialist

GTTAbbott Park, IL
Primary Job Title: QA Specialist Alternate / Related Job Titles: Quality Assurance Technician Quality Specialist – Bioanalytical QA Technician Laboratory Quality Specialist Quality Control Analyst Location & Onsite Flexibility: Abbott Park, IL – Onsite Contract Details: Position Type: Contract (Non-Exempt) Contract Duration: 6 Months Start: As Soon As Possible Pay Rate:$37.87/hour Overtime: Hours worked over 40 per week are paid at time and a half Job Summary: The QA Specialist is responsible for bioanalytical quality assurance testing within STARLIMS and SAP systems. This role owns and approves testing events, supports CAPA investigations, and maintains testing and product inventory in compliance with the Quality System. The QA Specialist operates with minimal supervision in a high-paced laboratory environment and serves as a subject matter expert (SME) for assigned certifications. Core Responsibilities: Implement and maintain the effectiveness of the Quality System Perform quality testing per procedures and review data to confirm conformance with specifications Execute testing in a high-throughput laboratory environment while maintaining multiple certifications Perform CAPA investigations for out-of-tolerance and out-of-specification results, including complaints Support ticket trending processes and maintain accurate quality records Communicate and collaborate effectively with team members and management Maintain accurate and complete documentation and records Participate in product and process improvement initiatives Monitor testing performance and implement continuous improvement actions Support GMP and GLP execution to ensure efficient lab operations Maintain and update relevant computer systems and applications Support manufacturing and testing operations while complying with GMPs, GLPs, EHS laws, and Quality System requirements Participate in training and reviews through the ISOtrain Learning Management System Ensure proper sample and file storage Actively participate in lab safety initiatives Serve as a point of contact for lab issues and assist with scheduling activities as needed Required Technical Skills (Hard Requirements): Bioanalytical testing experience with: HPLC SDS-PAGE Western Blot Dot Blot ELISA Mass Spectrometry (MS) Microtiter plate methods Required Qualifications: Bachelor’s degree in a science or closely related discipline 3–4 years of experience in quality functions within the healthcare industry Strong written and verbal communication skills Knowledge of diagnostic product manufacturing and testing Experience with stability testing, validations, technical troubleshooting, and compliance Familiarity with internal and external audits and performance metrics Ability to identify, escalate, and support resolution of non-conformances Basic computer proficiency and ability to work within STARLIMS and SAP Position Accountability / Scope: Execute daily testing activities assigned by schedulers, quality professionals, or management Identify and escalate quality issues and potential non-conformances Apply corrective actions with guidance from quality professionals Support lab operations and become an SME for lab certifications Benefits Medical, Vision, and Dental Insurance Plans 401(k) Retirement Fund About the Company Healthcare innovator dedicated to improving lives worldwide. The company offers a diverse portfolio including medical devices, diagnostics, nutrition products, and branded generics. Committed to developing breakthrough technologies that address critical healthcare challenges, the organization empowers people to live healthier lives while fostering a global, inclusive culture. About GTT GTT is a minority-owned staffing firm and a subsidiary of Chenega Corporation, a Native American-owned company in Alaska. As a Native American-owned, economically disadvantaged corporation, we highly value diverse and inclusive workplaces. Our clients are Fortune 500 banking, insurance, financial services, and technology companies, along with some of the nation’s largest life sciences, biotech, utility, and retail companies across the US and Canada. We look forward to helping you land your next great career opportunity! Job Number: 26-01202 #gttic #gttjobs

Posted 1 day ago

Lancesoft logo

QA Associate, Quality Operations

LancesoftNorton, MA
About the Role The QA Associate will help ensure that life-changing biopharmaceutical products are manufactured to the highest standards. The QA Associate will provide day-to-day QA support across manufacturing, validation, materials, QC, engineering and facility operations at our Norton site, partnering with cross-functional teams to maintain GMP compliance and inspection readiness. Key Responsibilities Provide raw material support, including review/approval of incoming material documentation and release for GMP use. Deliver on-the-floor QA support to manufacturing, including area clearance and changeover operations, ensuring readiness for production activities. Review and approve SOPs, master batch records (MBRs), specifications, risk assessments, and quality documents. Generate and maintain Quality-related SOPs and controlled forms. Review and approve validation documents and protocol executions to confirm compliance with approved procedures and regulatory requirements. Review and approve QC laboratory qualification documents, including equipment qualification. Perform executed batch record review and approval to ensure accuracy and compliance. Review and approve deviations, CAPAs, Change Controls and related investigations in the quality management system. Support partner audits and regulatory inspections, including document retrieval and subject matter input. Approve work orders in the maintenance system to verify equipment maintenance and calibration compliance. Collaborate with internal cross-functional teams at the Norton facility to drive continuous improvement and quality excellence. Qualification/Skills Bachelor s degree in a scientific or engineering discipline (Biology, Chemistry, Biotechnology, etc.) or equivalent experience. 2 4 years of GMP experience in Quality, Manufacturing, or QC. Knowledge of cGMP regulations (21 CFR Parts 210/211/11, ICH Q7/Q10) and Good Documentation Practices. Strong attention to detail, organizational skills, and the ability to communicate effectively across teams. Experience with quality systems (e.G., Veeva, SAP) is a plus.

Posted 1 week ago

Eli Lilly and Company logo

Scientist - Idap Packaging QA Flow Mentor

Eli Lilly and CompanyIndianapolis, IN

$65,250 - $169,400 / year

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

Overview

Schedule
Full-time
Career level
Senior-level
Compensation
$65,250-$169,400/year
Benefits
Health Insurance
Dental Insurance
Vision Insurance

Job Description

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.

Position Brand Description:

The Scientist- IDAP quality assurance flow mentor provides technical leadership and expertise for quality production support in the following areas: coaching and mentoring QA floor reps, developing and sustaining process knowledge, process and equipment support, process optimization and continuous improvement, sustaining quality management systems, and adherence to business processes. The Scientist- IDAP quality assurance flow mentor participates in regulatory inspections, collaborates in the site inspection readiness program, supports the APR process, and advises lead investigators, functional leaders, and site quality leader on production issues.

Key Objectives / Deliverables:

  • Coach and mentor QA floor reps through onboarding and qualification.
  • Coach and mentor QA floor reps in process understanding, problem solving, project management, and deviation resolution.
  • Support and peer review root cause analysis around operational events.
  • Promote and peer review documentation of learning points, gap assessments, and deviations.
  • Provide technical support to non-routine investigations and lead investigations for the quality function.
  • Work within cross-functional teams in a positive fashion to implement QA objectives and deliver on business plan and quality objectives.
  • Provide process and equipment support through identification of systemic issues affecting production (deviations, cycle time delays, etc.)
  • Lead or participate in root cause analysis and countermeasure development and implementation for major compliance or throughput event investigations.
  • Perform reviews of event documentation for technical accuracy and compliance.
  • Provide back up and shutdown support for QA floor reps as needed.
  • Identify and drive alignment of QA systems across IDAP.
  • Support APR program.
  • Support development and technical analysis for large-scale initiatives (secondary loop projects) such as productivity improvements, capacity development, GMP remediation, and safety risk mitigation.
  • Review and identify opportunities for continuous improvement and assist in prioritization of opportunities with respect to overall business objectives.
  • Collaborate with key support groups around the development of process knowledge and a common process improvement agenda.
  • Provide independent peer input / review of technical activities.
  • Provide support to the QA organization for deviation reduction and backlog prevention initiatives.
  • Analyze process team metrics for awareness and identification of potential improvement opportunities.

Basic Requirements:

  • Bachelor's Degree or equivalent work experience
  • 3 or more years in the pharmaceutical industry
  • Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

Additional Preferences:

  • Demonstrated strong oral and written communication and interpersonal skills.
  • Demonstrated decision making and problem-solving skills.
  • Demonstrated knowledge and understanding of manufacturing process and Quality Systems.
  • Demonstrated attention to detail.
  • Demonstrated ability to organize and prioritize multiple tasks.
  • Experience in Quality, TS/MS, or engineering is preferred.
  • Experience in device assembly and packaging processes.
  • Good knowledge of cGMP, external regulations and Lilly quality systems and requirements.
  • Experience leading root cause investigations.
  • Excellent technical writing skills.
  • Ability to function in a team environment as a leader and as a member of teams.
  • Ability to partner / network outside the IDAP site and participate in inspection readiness / continuous improvement initiatives.

Other Information:

  • The normal schedule for this position is Monday- Friday, 8 hours/day. However, back-up for floor QA reps and planned shutdown support may require support outside the normal schedule.
  • Travel (domestic and international) may be required.
  • Applicant may work in various areas within the IDAP plant. Some allergens are present in the IDAP plant.
  • Mobility requirements and exposure to allergens should be considered when applying for this position.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is

$65,250 - $169,400

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

#WeAreLilly

Automate your job search with Sonara.

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

pay-wall