Quality Assurance Associate III - Supplier Quality

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.

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

Schedule audits with Suppliers, provide written agenda and represent the company as lead auditor or co-auditor of the supplier GXP systems involving the following activities:

• Draft reports of areas reviewed during the audits and any deficiencies or recommendations for improvements
• Work with Rentschler management to get approval of the reports in MasterControl
• Maintain communication with the supplier to obtain audit responses that address the deficiencies cited in the report
• Communicate any objectionable conditions to Quality, Manufacturing and Supply Chain management
• Support maintenance of supplier records in Master Control and SAP
• Support supplier change notice processing, initiate internal change controls as required and ensure implementation of the change controls for supplier changes and closure of the records
• Support supplier corrective action processing in SAP for handling of defective material
• Support training program related to Auditing
• Support Data compliance reviews, as required
• Support supplier performance management program, as required

Qualifications

• Bachelor's degree or 5 years' related experience
• Excellent working knowledge of GMPs, including interpretation and application of regulations across pharmaceuticals and biologics, as well as EU Volume 4 Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use, ISO and PIC/S standards
• Strong communication skills, both orally and written
• Strong organizational and time-management skills, with ability to work to timelines and meet project milestones

Working Conditions

• Regular office working conditions
• Approximately 25 to 30 percent travel

Physical Requirements

• Personal Protective Equipment must be worn as required

Travel 25-35%