Responsible for delegate qualified person tasks, ensuring compliance with EU and Belgian regulatory requirements, GMP/GDP, and Lilly standards, and supporting quality activities across ELECTS QA and PR&D QA groups.
Compensation
The anticipated wage for this position is €67,500 - €99,000
Responsibilities
Perform EP batch release
Certify QP for FING material at EU Hub
Assess and approve deviations and change controls
Ensure compliance of clinical trial material with EU and Belgian regulations
Support investigations, qualification, validation, and QA processes within Multi Product Cell Culture and related areas at BMS.
Compensation
You’ll get a competitive salary and a great benefits package including an annual bonus, pension contribution, family medical allowance, 27 days of annual leave, life assurance and on-site gym
Responsibilities
Support review and approval of investigations within MPCC and supporting areas
Facilitate the investigation triage business process and the daily investigations meeting
Author, review, and approval of QA related procedures
Support implementation of site initiatives to prevent deviation recurrence
Promote Right First Time (RFT) approach within investigations process and drive accountability in meeting site investigation KPI’s
Responsible for ensuring GMP compliance during manufacturing and packing activities through line clearance, in-process checks, and shop-floor monitoring.
Responsibilities
Perform line clearance for manufacturing and packing activities
Conduct in-process checks and ensure GMP compliance
Review Batch Manufacturing Records (BMR), Batch Packing Records (BPR), and related documents
Prepare and review Annual Product Quality Review (APQR) reports
Leads and develops the Quality Assurance Operations team, ensuring compliance and continuous improvement of CAPA, deviation, qualification, and validation processes across production sites.
Locations (2)
Eigeltingen, Baden-Württemberg, Germany
Radolfzell, Baden-Württemberg, Germany
Responsibilities
Lead and develop QA Operations team
Serve as central quality contact for production, quality control, and technical areas
Ensure compliance and continuous improvement of CAPA, deviation, qualification, and validation processes
Support qualification and validation activities and monitor external sterilization processes
Analyze quality metrics, derive actions, and drive improvements with operational areas
Requirements
Bachelor's degree in natural sciences, technical, or pharmaceutical field or equivalent qualification
The QA Analytical Specialist will support Quality Assurance activities by reviewing and approving QC analytical testing records, laboratory investigations, and batch documentation to ensure compliance with GMP and regulatory requirements.
Compensation
Pay Rate: $36.96–$55.11/hour
Responsibilities
Review and approve analytical and microbiology testing records for raw materials, bulk drug substances, and drug products
Review and approve Out-of-Specification (OOS) investigations, deviations, change controls, and CAPAs
Evaluate analytical results against approved specifications and determine material and product disposition
Review executed batch records for drug substances, drug products, and packaged materials
Provide QA support for laboratory investigations, analytical testing issues, and manufacturing deviations
Requirements
Bachelor's degree in Biology, Chemistry, Engineering, or a related scientific discipline
Nice to have: analytical laboratory experience
Nice to have: analytical testing and analytical development
Nice to have: Knowledge of analytical laboratory equipment and instrumentation
Nice to have: Familiarity with USP, EP, ICH, and FDA regulatory guidelines
Lead clinical supply manufacturing with scientific rigor in processes within the Non-Sterile Process Engineering team at the FLEx Center in Rahway, ensuring right-first-time manufacture of high-quality drug products.
Locations (3)
Rahway, New Jersey, United States
San Francisco, California, United States
Los Angeles, California, United States
Compensation
The salary range for the primary location of this role is: $117,000.00 - $184,200.00. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
Responsibilities
Lead on-the-floor batch manufacturing in a pilot plant while prioritizing and ensuring safety and quality of clinical supplies
Draft and execute GxP documentation including, but not limited to, batch records, equipment qualification and cleaning, change records and deviations
Lead and develop a QC team responsible for the analysis and release of starting materials and raw materials, ensuring timely and high-quality results in accordance with GMP and SOPs.
Responsibilities
Lead, coach, and develop the team with personal and budget responsibility
Plan, prioritize, and follow up on daily work based on business needs
Ensure starting materials and raw materials are analyzed and released within agreed timelines
Ensure daily work adheres to SOPs, GMP, and safety regulations
Act as a central contact person for release and analysis questions
Requirements
Academic degree in analytical chemistry or equivalent
Plan, coordinate, and execute assigned commissioning, qualification, and validation activities (IQ, OQ, PQ) in alignment with project schedules and milestones
Personally conduct and supervise the execution of qualification tests to guarantee compliance with design specifications and regulatory requirements
Prepare, review, and maintain high-quality C&Q documentation such as protocols, reports, deviation records, and traceability matrices
Ensure all C&Q activities comply with applicable GMP, GxP, and regulatory requirements (e.g. EU GMP, FDA) and are always inspection-ready
Contribute to the continuous improvement of C&Q processes, templates, and standards to enhance efficiency, compliance, and inspection readiness
Requirements
Degree (university or university of applied sciences) in chemical, mechanical or process engineering, biotechnology, pharmaceutical technology, chemistry or a comparable field or significant professional experience in the biopharmaceutical industry under GMP
Identify and resolve technical and operational problems, collaborating with peers to resolve problems that cross into interrelated units
Facilitate and support early process development by assisting in lab activities, and supporting knowledge transfer for scaling at pilot plant scale with relevant partners, via technical reports and presentations
Propose new, innovative approaches for enhanced process and product understanding
Requirements
Bachelor of Science degree in Chemical Engineering, Biomedical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field with a minimum of 5 years relevant experience
Master’s degree in Chemical Engineering, Biomedical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field with 3 years of relevant experience
PhD in Chemical Engineering, Biomedical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field (with expected graduation no later than December 2026)
Nice to have: GxP manufacturing in a pilot plant or a commercial manufacturing environment
Nice to have: Small molecule drug product manufacturing technologies (blending, granulation, compression, encapsulation, film coating, spray drying, hot-melt extrusion)
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