The Sr Scientist QA Operations leads production and drug release for pharmaceutical solutions, ensuring compliance and quality in manufacturing processes and batch records.
Work Schedule
Standard (Mon-Fri)Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)Job Description
Looking to contribute to a team with outstanding chances to define global impact? As a Sr Scientist QA Operations at Thermo Fisher Scientific Inc., you'll lead production and drug release for innovative pharmaceutical solutions.
Responsibilities:- Ensure compliance of manufacturing processes, batch records, deviations, change control, and CAPAs.
- Review and approve completed batch records within defined timelines.
- Responsible for technical batch release.
- Provide active on-the-floor support during critical manufacturing steps.
- Review and approve operational elements such as procedures and related documents, including specifications, working instructions, and impact assessments.
- Assist with continuous improvement initiatives related to quality documents and processes.
- Supervise the preparation of the Annual Product Review (APQR) and ensure its timely execution.
- Maintain and share data integrity rules (ALCOA+).
- Propose improvements to improve flows, manufacturing activities, and organization.
- Master's degree or higher in Life Sciences (e.g., Chemistry, Biochemistry, Biology, Pharmacist).
- At least 3-5 years of experience in the pharmaceutical industry (biotech company) with a minimum of 1 year in commercial batch release.
- Knowledge of pharmaceutical manufacturing processes, especially biologic drug substances.
- Proficient communication skills in German and English.
- Experience with SAP and electronic MES (manufacturing execution system) is an asset.
- Availability for on-call services and remote work based on department needs.
Top Skills
Electronic Mes
SAP
Thermo Fisher Scientific Waltham, Massachusetts, USA Office
168 Third Avenue, Waltham, MA, United States
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