6 дней назад
QC Lab Team Supervisor (Biopharma)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
QC Lab Team Supervisor (Biopharma): Managing pharmaceutical and vaccine quality control laboratory operations with an accent on GMP compliance, analytical testing, team development, and laboratory systems. Focus on leading hands-on particulate, Micro-FTIR, SEM/EDS, and CCIT testing, resolving quality events, and maintaining validated equipment and methods.
Location: Swiftwater, Pennsylvania, United States; laboratory-based role with standard working hours and possible overtime based on operational needs.
Company
is an R&D-driven biopharmaceutical company developing medicines and vaccines through science, digital technology, data, and AI.
What you will do
- Oversee daily quality control laboratory operations, sample testing, scheduling, shopfloor reviews, and operational continuity.
- Maintain compliance with GMP requirements, validated methods, regulatory standards, CAPAs, deviations, change controls, and audit readiness.
- Lead, train, qualify, and mentor laboratory staff while maintaining the laboratory qualification matrix and training compliance.
- Perform and oversee specialized testing, including particulate isolation, optical microscopy, Micro-FTIR, FTIR, SEM/EDS, CCIT, and BLGF testing.
- Manage equipment maintenance, qualification, and calibration, and author technical memorandums, reports, and quality documents.
- Support investigations, customer complaints, inspections, safety initiatives, and continuous improvement activities.
Requirements
- Bachelor’s degree in Life Sciences, Pharmaceutical Sciences, Engineering, or a related scientific field.
- At least 8 years of experience in a cGMP environment, with progressive QC experience in pharmaceutical or vaccine manufacturing.
- Hands-on experience with particulate isolation, Micro-FTIR, and SEM/EDS analysis in a regulated pharmaceutical environment.
- Strong knowledge of GMP and FDA, EMA, and ICH regulatory requirements, as well as method validation and transfer protocols.
- Experience with laboratory instrumentation, LIMS, TrackWise, SAP, iLearn, and related quality systems.
- Strong leadership, analytical, communication, problem-solving, and prioritization skills.
Nice to have
- Experience with USP, EP, and JP compendial testing standards.
- Continuous improvement and Lean experience, including cost and efficiency metrics.
- Experience as an HSE safety representative, conducting GEMBA walks, laboratory inspections, and safety initiatives.
Culture & Benefits
- Supportive, science-focused environment with opportunities for promotion and international career development.
- Employee rewards and benefits package with healthcare, prevention, and wellness programs.
- At least 14 weeks of gender-neutral parental leave.
- Work focused on medicines, vaccines, digital innovation, data, and AI-driven manufacturing and supply operations.
- Laboratory work includes exposure to chemicals and specialized equipment, with PPE required when applicable.
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