External Quality Assurance Associate III

Rentschler Biopharma is a leading global contract development and manufacturing organization (CDMO) for biopharmaceuticals. From our headquarters in Laupheim, Germany, and our site in Milford, MA, USA, we offer end-to-end solutions, including bioprocess development and manufacturing, as well as related consulting activities such as project management and regulatory support. In Stevenage, UK, we have launched Rentschler ATMP Ltd. dedicated to cell and gene therapies.

We are a family-owned company with approximately 1.400 employees from 25 nationalities. What unites us at Rentschler Biopharma, is the passion for what we do. We empower our clients to help patients with serious or rare diseases. With our dedication and expertise, we convert medical research into outstanding biopharmaceuticals. Thus, we provide an important contribution to the global availability of essential therapies.  Going forward, we are expanding our team to ensure our long-term sustainable growth. Join us and be part of a unique journey, shaping the future of biopharmaceutical manufacturing together!  

Duties and Responsibilities

• Serve as the Quality Point of Contact between the QA team and customers
• Represent the Quality organization on collaborative cross functional program teams
• Review documents, records, and reports relative to new product introduction 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) of new product introduction for the Quality organization by reviewing and approving technical documents such as, engineering, 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