Quality Assurance Associate III - Operations

at  Rentschler Biopharma SE

Rentschler Biopharma ist ein führendes Auftragsentwicklungs- und Produktionsunternehmen (CDMO) für Biopharmazeutika. Am Hauptsitz in Laupheim, Deutschland, sowie einem zweiten Standort in Milford, MA, USA, bieten wir Full-Service Lösungen für die Bioprozessentwicklung und die Herstellung hochwertiger Biopharmazeutika sowie damit verbundene Beratungsleistungen einschließlich Projektplanung und regulatorischer Unterstützung an. In Stevenage, UK, haben wir das auf Zell- und Gentherapie spezialisierte Unternehmen Rentschler ATMP Ltd. gegründet.
Wir sind ein Familienunternehmen mit rund 1.400 Mitarbeiter/-innen aus 25 Nationen. Was uns bei Rentschler Biopharma vereint, ist die Leidenschaft für das, was wir tun. Wir versetzen unsere Partner in die Lage, Patienten mit schweren oder seltenen Erkrankungen zu helfen.
Mit unserer Hingabe und unserem Wissen wandeln wir medizinische Forschung in ausgezeichnete Biopharmazeutika um. So leisten wir einen entscheidenden Beitrag zur weltweiten Verfügbarkeit essenzieller Therapien. Um unser langfristiges und nachhaltiges Wachstum zu sichern, bauen wir unser Team weiter aus. Werden Sie Teil unseres einzigartigen Teams und gestalten Sie mit uns gemeinsam die Zukunft der Biopharma-Branche!

Duties and Responsibilities

• Represent the Quality organization on collaborative cross functional program teams
• Review and approval of QMS records (Deviation/Events, CAPA, Change Control, OOS etc.)
• Serves as QC process support by reviewing QC data packages/test results/ Raw Material release/ Material Specification etc
• Review documents, records, and reports such as Master Manufacturing Batch Records, specifications, protocols, etc. against client needs as well as internal Standard Operating Procedures (SOPs) for accuracy and compliance to procedures based on Good Documentation Practices, regulatory requirements, and internal guidelines
• Serve as Subject Matter Expert (SME) for the Quality organization by reviewing and approving technical documents such as, validation, stability, development studies, etc
• Write, review, analyze and revise written Standard Operating Procedures (SOPs) and submit procedural changes as needed to meet Corporate, Site and other regulatory requirements
• Determine the logic, adequacy and effectiveness of Quality processes, systems, and related requirements
• Participate in continuous improvement initiatives within the department and site wide
• Provide training to employees on relevant Quality and compliance area(s)
• Participate in external assessments and audits by evaluating and solving product/process problems by providing technical and analytical skills, as needed
• Support internal and external inspection process with timely closure of observations/audit items
• Other duties, tasks or projects as assigned

Qualifications

• Bachelor’s Degree in STEM
• 5+ years of experience in the Quality function within a biotech or pharmaceutical company or other similarly regulated industry
• Strong knowledge of FDA cGMP regulatory requirements as they apply in a biologics manufacturing environment
• Strong knowledge of manufacturing processes and the impact of deviations on the quality of the product
• Expertise in electronic quality systems including advanced data mining/reporting and query building
• Strong interpersonal skills and great attention to detail are necessary
• Must be a strong team player with good problem solving, and good verbal and written communication skills, and the ability to multi-task, with rapidly changing priorities
• Microsoft Office – Outlook, Word, Excel

Preferred Qualifications

• Professional Quality certifications a plus (CQA, CQE, CQM, RABQSA)
• Prior experience in an external quality role is a plus
• Additional computer experience should include utilizing industry standard quality and MS Office systems; advanced Excel skills are a plus
• Change control experience is a plus

Working Conditions

• Clean room environment
• Personal Protective Equipment must be worn as required
• Normal office working conditions: computer, phone, files, copier
• Will interact with other people
• Pace may be fast and job completion demands may be high

Physical Requirements

• Frequent standing/walking to work in controlled environment for extended periods
• Frequent sitting for extended periods to use computer

• Represent the Quality organization on collaborative cross functional program teams
• Review and approval of QMS records (Deviation/Events, CAPA, Change Control, OOS etc.)
• Serves as QC process support by reviewing QC data packages/test results/ Raw Material release/ Material Specification etc
• Review documents, records, and reports such as Master Manufacturing Batch Records, specifications, protocols, etc. against client needs as well as internal Standard Operating Procedures (SOPs) for accuracy and compliance to procedures based on Good Documentation Practices, regulatory requirements, and internal guidelines
• Serve as Subject Matter Expert (SME) for the Quality organization by reviewing and approving technical documents such as, validation, stability, development studies, etc
• Write, review, analyze and revise written Standard Operating Procedures (SOPs) and submit procedural changes as needed to meet Corporate, Site and other regulatory requirements
• Determine the logic, adequacy and effectiveness of Quality processes, systems, and related requirements
• Participate in continuous improvement initiatives within the department and site wide
• Provide training to employees on relevant Quality and compliance area(s)
• Participate in external assessments and audits by evaluating and solving product/process problems by providing technical and analytical skills, as needed
• Support internal and external inspection process with timely closure of observations/audit items
• Other duties, tasks or projects as assigne