Senior QA API External Manufacturing - Global GMP Oversight
$65.25k - $169.4kEli Lilly and Company
A global healthcare leader located in Indianapolis, Indiana is looking for a Senior / Principal Associate QA API External Manufacturing. This role involves providing quality oversight at Contract Manufacturing organizations, ensuring compliance with quality agreements and regulatory commitments. Ideal candidates should have a BS in a science-related field and five or more years of GMP manufacturing experience. The compensation ranges from $65,250 to $169,400, and the position includes various benefits and a company bonus. #J-18808-Ljbffr Eli Lilly and Company
$65.25k - $169.4k
...around the world. We are a global healthcare leader... ...Position Overview The Senior / Principal Associate QA API External Manufacturing provides support to all... ...Lilly; provide quality oversight of CMs, including being... ...Five or more years of GMP manufacturing knowledge...SeniorFull timeContract workFlexible hours$65.25k - $169.4k
Job Summary Eli Lilly and Company seeks a highly motivated and experienced Senior / Principal Associate QA API External Manufacturing to ensure the quality and compliance of externally manufactured Active Pharmaceutical Ingredients (APIs) in accordance with cGMP regulations...SeniorFull timeFlexible hours$65.25k - $169.4k
...around the world. We are a global healthcare leader... ...Pharmaceutical Ingredient - External Manufacturing Organization (API-EM) that delivers a diverse... ...essential Quality Assurance oversight for API External Manufacturing... .... Provide expert QA guidance and support during...SuggestedFull timeH1bVisa sponsorshipWork visaFlexible hours- ...Lilly and Company is seeking a QA Representative in... ...Indiana, to ensure quality oversight of contract manufacturing. The role involves managing... ...and ensuring compliance with Global Quality Standards. The ideal... ...+ years of experience in a GMP-regulated setting. This position...SuggestedContract workCasual work
$93.8k - $174.2k
...experienced engineer to support capital initiatives and manufacturing technologies in a GMP-regulated environment. Candidates should have a Bachelor'... ...experience in the pharmaceutical industry, particularly with API manufacturing and isolator containment systems. The...Senior$66k - $171.6k
...Principal Process Engineer - API EM Large Molecule... ...with API EM contract manufacturer personnel in the... ...Engaged with internal and external resources in developing... ...‑and long‑term needs Oversight of HSE and PSM Serve... ...liaison for API EM and Global HSE on health, safety,...Full timeContract workTemporary workWork experience placementH1bVisa sponsorshipWork visaRelocation packageFlexible hours$141.52k - $171.48k
...biotech with the global expertise and... ...RayzeBio: The Senior Manager of Chemistry, Manufacturing & Controls (CMC)... ...drug substance, API, drug product, and... ...providing Quality (QA) input from pre-... ...member for oversight and QA approver... ...Quality events and/or GMP documentation,...SeniorHourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaImmediate startRemote workFlexible hours$64.5k - $167.2k
...around the world. We are a global healthcare leader... ...Pharmaceutical Ingredient - External Manufacturing Organization (API‑EM) that delivers a diverse... ...Manufacturing Practices (GMP), regulatory requirements,... ...Deliverables Provide technical oversight and stewardship for Small...SeniorFull timeH1bWorldwideVisa sponsorshipWork visaFlexible hours$123k - $180.4k
...Technical Services/Manufacturing Science (TS/MS) Dry Products External Manufacturing (... ...supporting oversight of external manufacture... ...teams, and global contract... ...objectives, and GMP quality plan objectives... ...issues to senior leaders in a... ...Dry EM team. API-EM group. External...Full timeContract workTemporary workFlexible hoursShift workNight shiftWeekend work$68.5k - $88.02k
...This job family provides oversight of production/manufacturing activities, training to operational... .... Job Summary The Senior Specialist, Quality Assurance... ...audits (internal and external) and develops actionable insights... ...in eQMS system. Maintains GMP record retention. Assures...SeniorTemporary workWork experience placementLocal areaFlexible hours$65.25k - $169.4k
...around the world. We are a global healthcare leader... ...new center for advanced manufacturing and drug development.... ...Foundry and with external partners comply with global... ...will provide quality oversight for the detailed design... ...processes related to GMP testing and analytical...SeniorPermanent employmentFull timeContract workFlexible hours$66k - $171.6k
...Active Pharmaceutical Ingredient - External Manufacturing Organization (API-EM) that delivers a diverse portfolio... ...groups to predetermined global quality standards. This person interacts... ...Responsibilities Provide technical oversight for biologics manufacturing processes...SeniorFull timeContract workWork experience placementH1bRelocationVisa sponsorshipWork visaFlexible hoursShift workNight shiftWeekend work- GMP Quality Assurance Associate needs 5+ years of GMP Quality... ...and/or experience in API or finished product manufacturing, QA or Engineering. GMP Quality... .... Maintain awareness of external regulatory agency findings... ...productivity. #J-18808-Ljbffr Global Channel Management
- ...seeking a Principal QA Process Validation... ...technical Quality oversight and subject matter... ..., MSAT, Manufacturing, Validation, and Quality... ...internal standards and global regulatory... ...2, and applicable GMP requirements (this... ...will qualify at the Senior level. 10+ years of...
$40 - $45 per hour
...to support LabVantage LIMS implementation. This role is remote and primarily involves authoring and executing GMP-compliant change controls within manufacturing and quality operations. The ideal candidate will have 5+ years in GMP Quality Assurance, experience with...Remote jobHourly pay- ...professional based in Indianapolis, Indiana, to provide oversight and support within a regulated manufacturing environment. The role involves reviewing production... ...roles. Strong communication skills and knowledge of GMP are essential for success. #J-18808-Ljbffr Harba
- ...bioengineering. We develop, manufacture, and bank cell therapy... ...with internal/external standards, regulations,... ...the Quality Assurance (QA) release of the product... ...and projects with little oversight Capable of effectively... ...AATB Standards, and other GMP requirements Familiarity...Work at officeRemote workMonday to Thursday
- Luxoft у Сполучених Штатах, Індіана, шукає Regular/Senior Manual QA для тестування систем у сфері Digital Banking. Робота передбачає виконання ручного тестування мобільних додатків і API, а також розро бку тест-кейсів. Кандидати повинні мати не менше 3 років досвіду, володіти...Senior
- Ossium in Indianapolis is looking for an Associate Director of Engineering to lead GMP/GTP manufacturing operations. You will be responsible for driving reliability and compliance within a highly regulated environment while mentoring a skilled engineering team. The role...Senior
- A global healthcare leader in Indianapolis is seeking a Process Safety Lead to provide technical support for process safety in manufacturing. The ideal candidate will have at least 8 years of experience in related environments and a Bachelor's degree in Engineering. Responsibilities...Senior
- Bristol-Myers Squibb is seeking a Senior Automation/Controls Engineer for their facility... ...systems for radiopharmaceutical manufacturing and requires strong leadership and project... ...compliance and continuous improvement in a GMP-regulated setting. #J-18808-Ljbffr Bristol...Senior
- ...with animals!****As a global leader in animal health... ...teams within R&D and Manufacturing and will require organizational... ...and maintain some GMP/USDA capabilities and... ...and program oversight, including lab supervision... ...teams, manufacturing, and external collaborators to...SeniorSummer workLocal areaRelocationFlexible hours
- ...Eli Lilly and Company is seeking a Principal Process Engineer - API EM Large Molecule to provide technical leadership and ensure... ...coaching team members, leading technology transfers, and improving manufacturing processes. Ideal candidates will have 5+ years in chemical...Senior
- Initial Therapeutics, Inc. is seeking a Functions Learning Leader in Indianapolis to oversee global learning initiatives within Manufacturing and Quality. This role involves leading a high-performance team, implementing strategies aligned with compliance standards, and...Senior
$66k - $171.6k
...Company is seeking a Process Control and Automation Engineer for their new manufacturing facility in Lebanon, Indiana. The role involves managing application upgrades, ensuring compliance with GMP standards and collaborating on engineering initiatives. Qualified...Senior$123k - $180.4k
...Technical Services / Manufacturing Science (TSMS) - API leads technical and people... ...plan objectives, and GMP Quality Plan... ...support of internal and external agency audits. Ensure adequate oversight and technical excellence... ...agendas. Network globally to share best practices...Full timeTemporary workFlexible hoursShift workNight shiftWeekend work- ...Heartland Food Products Group is a global leader in the consumer packaged goods (CPG) industry... ...creamers and liquid water enhancers. We manufacture and market Splenda, the #1 brand in the... ...policies and procedures. Follows GMP’s, maintains sanitary conditions, adheres...SeniorWork at officeFlexible hours
- Oversees day-to-day activities of Quality Assurance teams supporting manufacturing and processing operations. Establishes and tracks key... ...Manages staffing, professional development, and budgeting for QA team members. Leads investigations into product quality issues...Senior
- ...overseeing quality control activities and ensuring compliance with cGMP regulations at third-party manufacturers. Candidates should have over 5 years of experience in GMP Quality Control Laboratories and a BS in a science-related field. The position requires full support...
- A leading global healthcare firm in Indianapolis is looking for a Senior Principal Engineer - Automation Engineering. This role involves providing... ...in biopharma or pharmaceutical manufacturing. Strong problem-solving skills and GMP knowledge are essential. Competitive salary...SeniorFull time
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