QA Associate I, Hardware/Systems

Overview Repligen is an innovative life sciences company focused on developing and commercializing high-value bioprocessing products, technologies, and solutions critical in the production of biologic drugs. We are currently seeking a QA Associate I to join our Quality team in Marlborough. The successful candidate will be responsible for assisting the QA department to revise/create, file, organize, and review production documents. The candidate will work closely with the manufacturing team and document control department to ensure the changes are accurate and are made effective in a timely manner. This position involves completing the QA review of production records, including verification of raw materials used, verification of calculations, critical process steps, and evaluation of Factory Acceptance testing (FAT). The QA Associate I will actively participate in the Repligen ISO 9001 Quality Management System and will be responsible for the review of system batch records and binder builds for Xcell ATF and Systems product lines and other TFF and TFDF systems. Responsibilities Responsibilities: Must be familiar with Factory Acceptance Test (FAT) for stainless steel cell culture systems Must have knowledge of ASME BPE codes and requirements Must be able to perform Quality Assurance on manufacturing of system product lines Must be able to build binders (Hardcopy/ eCopy) for Factory Acceptance Test (FAT) Must be familiar with GMP/ non-GMP systems used by pharmaceuticals Must be able to work with Document Control for issuance of batch records Must have good communication skills to work with customers Qualifications Requirements: At a minimum, a BA/BS degree (in a Biological Science, Engineering, or Physical Science preferred). Minimum 0-2 years' experience in Quality Assurance in an ISO 9001 certified Quality Management System or equivalent Ability to identify and ensure active and thorough investigations of quality issues identifying root causes and implementing corrective actions. Identifies and controls manufacturing process defects (scrap, nonconforming material, customer complaints) is highly preferred. What Repligen Offers Excellent Benefits! Health Insurance available on day one 4 Competitive Medical Plan Options Dental, Vision, Life and Disability Insurance Plans 401K Health Care Savings Account Well Being Programs 20 Days of PTO Tuition Reimbursement Program

Created: 2024-11-05