External Quality Assurance Associate III

3 weeks ago

Milford, United States Rentschler Full time

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 ResponsibilitiesServe as the Quality Point of Contact between the QA team and customersRepresent the Quality organization on collaborative cross functional program teamsReview 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 guidelinesServe 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, etcWrite, review, analyze and revise written Standard Operating Procedures (SOPs) and submit procedural changes as needed to meet Corporate, Site and other regulatory requirementsDetermine the logic, adequacy and effectiveness of Quality processes, systems, and related requirementsParticipate in continuous improvement initiatives within the department and site wideProvide 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 neededSupport internal and external inspection process with timely closure of observations/audit itemsOther duties, tasks or projects as assignedQualificationsBachelor's Degree in STEM5+ years of experience in the Quality function within a biotech or pharmaceutical company or other similarly regulated industryStrong knowledge of FDA cGMP regulatory requirements as they apply in a biologics manufacturing environmentStrong knowledge of manufacturing processes and the impact of deviations on the quality of the productExpertise in electronic quality systems including advanced data mining/reporting and query buildingStrong interpersonal skills and great attention to detail are necessaryMust 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 prioritiesMicrosoft Office - Outlook, Word, ExcelPreferred QualificationsProfessional Quality certifications a plus (CQA, CQE, CQM, RABQSA)Prior experience in an external quality role is a plusAdditional computer experience should include utilizing industry standard quality and MS Office systems; advanced Excel skills are a plusChange control experience is a plusWorking ConditionsClean room environmentPersonal Protective Equipment must be worn as requiredNormal office working conditions: computer, phone, files, copierWill interact with other people Pace may be fast and job completion demands may be highPhysical RequirementsFrequent standing/walking to work in controlled environment for extended periodsFrequent sitting for extended periods to use computer

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