Drug Substance QA Engineer - Compliance & Quality
FUJIFILM Biotechnologies
Fujifilm Biotechnologies in Holly Springs, NC, seeks a QA Engineer for Drug Substance to oversee quality across manufacturing, testing, and distribution, ensuring adherence to cGMP and GDP. You will guide Manufacturing, Quality Control, and Facilities staff, supporting audits and inspections. The role emphasizes coaching, issue resolution, and driving continual improvements within QA and manufacturing processes in a multi-disciplinary setting. #J-18808-Ljbffr
Vacancy posted 1 day ago
Similar jobs that could be interesting for youBased on the Drug Substance QA Engineer - Compliance & Quality in Holly Springs, NC vacancy
- ...Position Overview The QA Engineer, Drug Substance will serve as a Quality Assurance Specialist responsible for manufacturing quality assurance, working... ...Supply Chain, and Facilities & Engineering staff on compliance, quality systems, day-to-day QA oversight, and...Quality
FUJIFILM Corporation
Holly Springs, NC1 day ago - ...Position Overview The Engineer, QA Drug Substance Manufacturing is responsible to help drive the Quality oversight for the direction of all Drug Substance Manufacturing... ...Basic knowledge and application of cGMP compliance and other related regulations. Fully embraces...QualityFlexible hours
FUJIFILM Corporation
Holly Springs, NC3 days ago - ...processes, and systems to meet delivery, compliance, and financial objectives. The role... ...manufacturing facility, offering drug substance production, fill-finish, and packaging... ...multiple levels and ensure alignment with Quality, Engineering, Supply Chain, and Process Sciences....QualityTemporary work
FUJIFILM Corporation
Holly Springs, NC3 days ago - ...Position Overview The QA Engineer, Digital Technologies is responsible for partnering in the Quality oversight of IT and Automation... ...manufacturing facility, offering drug substance production, fill-finish,... ...and application of cGMP compliance and other related regulations...QualityFlexible hours
FUJIFILM Corporation
Holly Springs, NC1 day ago - ...Position Overview The Program Quality Manager (PQM) serves as the... .../mission (strategy and compliance). The Program Quality Manager... ...manufacturing facility, offering drug substance production, fill-finish, and... ...Life Sciences, Chemistry or Engineering or equivalent with 5+ years...QualityContract work
FUJIFILM Biotechnologies
Holly Springs, NC1 day ago - ...Manufacturing Manager for upstream bulk drug substance production at its advanced... ...in GMP operations, ensuring compliance, staff development, and... ...degree in life sciences or engineering, or equivalent education... ...manufacturing systems (EBR/MES, Delta V, electronic quality systems)...QualityWork at officeShift workNight shift
Amgen
Holly Springs, NC8 days ago - ...The Associate Director, Drug Substance MSAT, leads end-to-end... ...of scientists and engineers, and optimizes large scale... ...team, Manufacturing, QA, Automation, and... ...translating product critical quality attributes into... ...presence, safety, and compliance as well as successful...QualityShift work
FUJIFILM
Holly Springs, NC15 hours ago - ...pm or 6pm-6am schedule. The QA Operations Shift Supervisor is... ...risk-based QA support of the Drug Product Manufacturing area and... ...day-to-day supervision of the Quality Assurance (QA) Operations Drug... ...goals for self and team to ensure compliance with cGMPs and regulatory...QualityFull timeMonday to FridayShift workNight shiftRotating shiftAfternoon shift
FUJIFILM Biotechnologies
Holly Springs, NC2 days ago $114.7k - $212.9k
...standard for high-volume, highly-efficient Drug Product manufacturing. The facility's... ...processes to produce the highest quality medicines. This plant meets today’s demand... ...seek a highly impactful Principal Quality Compliance Specialist who will serve as the site Inspection...QualityLocal areaRelocation packageGenentech
Holly Springs, NC5 days ago- ...FUJIFILM Biotechnologies in Holly Springs, NC, seeks a QA Engineer, Digital Technologies to oversee IT and automation systems within a cGMP environment. You will partner with the DT Quality team to ensure QA governance for project deliverables and accurate validation...Quality
FUJIFILM Corporation
Holly Springs, NC3 days ago - ...The QA Specialist, Operations is responsible for partnering in the Quality oversight of Drug Substance Manufacturing processes. This role provides... ...and application of cGMP compliance and other related regulations... .../BA in Life Sciences or Engineering or equivalent with 2+...QualityFull timeImmediate startFlexible hours
FUJIFILM Biotechnologies
Holly Springs, NC3 days ago - ...Manufacturing for upstream bulk drug substance production at its North... ...manufacturing operations in compliance with cGMP procedures and regulations... ...documentation Initiate quality observations and support... ...with quality assurance, engineering, and process development teams...QualityWork at officeShift work
$30 - $32 per hour
...supports the release and ongoing quality monitoring of intermediates... ..., and helps ensure compliance with regulatory and internal... ...environment. Handle controlled substances in accordance with... ...Actalent is a global leader in engineering and sciences services and talent...QualityContract workTemporary workActalent
Cary, NC4 days ago- ...Seqirus in Holly Springs, NC is seeking a QA Specialist (Day) to oversee on-floor quality for manufacturing, laboratories, utilities, maintenance and logistics. You will ensure cGMP compliance and support site quality programs. You will perform real-time batch record...QualityDay shift
CSL Plasma
Holly Springs, NC1 day ago - ...performed safely, consistently, and in compliance with cGMP requirements. You will also coordinate... ...establish a strong culture of safety, quality, and operational excellence. **... ...manufacturing facility, offering drug substance production, fill-finish, and packaging...QualityFull timeRelocation packageShift work
- ...building award-winning games or crafting engine technology that enables others to make visually... ...bar of engine and game development. QUALITY ASSURANCE What We Do The Quality... ...customers. What You'll Do People within the QA Engineer career track work with product...Quality
Epic Games
Cary, NC2 days ago - ...Fujifilm Biotechnologies in Holly Springs, NC, seeks a strategic Director of Quality Systems and Compliance to lead PQS, audits, documentation, and global regulatory readiness. This role partners across functions to strengthen data integrity and a proactive quality culture...Quality
FUJIFILM Biotechnologies
Holly Springs, NC3 days ago - ...FUJIFILM Biotechnologies in Holly Springs, NC seeks a Senior Program Quality Manager to lead quality programs from contract signature to closure, acting as primary client liaison and ensuring compliance with GMP and regulatory requirements. You will coordinate cross-...QualityContract work
FUJIFILM Biotechnologies
Holly Springs, NC5 days ago - ...Director (AD), Program Quality Management is... ...ensures timely delivery of QA services. This role operates... ...facility, offering drug substance production, fill-finish... ...intelligence and compliance. Commitment to sustainability... ...in Life Sciences, Engineering or related science...QualityFlexible hours
FUJIFILM Biotechnologies
Holly Springs, NC5 days ago - ...Automation, Selenium (8+ Years)Understanding of Quality Assurance best practices and methodologiesAware of scripting and automation frameworks with languages like Java, PythonHave successfully managed and delivered results with teams in agile and waterfall methodologiesExperience...Quality
Omni Inclusive
Cary, NC5 days ago - ...functional leaders (Operations, Quality, EHS, Supply Chain, Finance,... ...facility, offering drug substance production, fill-finish, and... ...service, quality, safety, and compliance, providing transparent reporting... ...'s degree in Business, Engineering, Operations, or related field...QualityShift work
FUJIFILM Corporation
Holly Springs, NC4 days ago - ...Genentech in Holly Springs, NC seeks a Senior Quality Compliance Specialist to integrate risk-based quality practices into aseptic drug product manufacturing startups. You will design and own Quality Risk Management and Data Integrity initiatives across cross-functional...QualityRelocation package
Genentech
Holly Springs, NC3 days ago - ...Quality Control Field CoordinatorThe Quality Control Field Coordinator on site is responsible... ....Create/fill required daily or weekly QA/QC forms.Requirements / Qualifications:4-7... ...of a pre-employment background check and drug screening. Each situation is reviewed individually...QualityTemporary workImmediate start
Precision Walls
Apex, NC1 day ago $120k - $135k
...Building Brands is seeking a Supplier Quality Manager to drive quality improvement with... ...lead coaching initiatives, and ensure compliance with company standards. This role requires... .... Qualifications Bachelor's degree in engineering, Industrial Discipline, or related...QualityFull timeWork at officeCornerstone Building Brands
Cary, NC4 days ago$85k - $110k
...for an accommodation or an alternative application process. Quality Assurance Engineer NC Cary, NC, US Salary Range: $85,000.00 To $110,000.00... ...materials, in-process components, and finished products to ensure compliance with quality standards. Collaborate with production and...QualityTemporary workTemposonics LLC
Cary, NC4 days ago- ...Administrator-Salary Quality ControlCompensation ServicesCrossroads III, Cary, NCAdministrator Band 4ExemptNoMonday-Friday (occasional... ...for managing salary exceptions and ensuring the accuracy and compliance with DPI payroll-related processes. Supervises the Quality...QualityWork at officeRemote workAfternoon shift
Wake County Public Schools
Cary, NC15 hours ago - ...Senior Process Engineer position supporting design, commissioning... ...autoclave systems at a new advanced drug substance manufacturing facility. Role... ...troubleshooting, regulatory compliance, and continuous improvement... ...with manufacturing, quality, maintenance, and cross-functional...Quality
- ...policies, procedures, and training and in compliance with regulations set forth by the... ...Supports the organization commitment to the Quality Enhancement Program (QEP) and CQI Activities... ...Fresenius Medical Care maintains a drug-free workplace in accordance with applicable...QualityImmediate start
Fresenius Medical Care
Holly Springs, NC3 days ago $94k - $174.6k
...Senior QA SpecialistWelcome to Holly Springs, North... ..., highly-efficient drug product manufacturing.The... ...to produce the highest quality medicines. This plant meets... ...focus and a strong compliance mindset. This critical... ...Chain, and Facilities/Engineering.Who You AreBachelor's degree...QualityLocal areaRelocation packageGenentech
Holly Springs, NC2 days ago- ...acceptance criteria, identify risks, and plan test coverage with QA, product, and development stakeholders. Build test tooling... ...client-to-backend service communications. Analyze and report quality data, troubleshoot defects, and support development teams before...QualityFull time
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Drug Substance QA Engineer - Compliance & Quality. Be the first to apply!
Related searches
- quality tech Holly Springs, NC
- air quality Holly Springs, NC
- water quality Holly Springs, NC
- quality improvement rn Holly Springs, NC
- quality manufacturing Holly Springs, NC
- quality Holly Springs, NC
- quality improvement nurse Holly Springs, NC
- quality lead Holly Springs, NC
- supplier quality Holly Springs, NC
- water quality scientist Holly Springs, NC