External Quality Assurance Associate II

Rentschler Biopharma • Milford, MA

1d

About The Position

Advancing medicine to save lives. Together. Thanks to many decades of experience and our passion for what we do, we make an essential contribution to the global availability of biopharmaceuticals, especially for patients with rare and serious diseases. Rentschler Biopharma SE is a leading contract development and manufacturing organization (CDMO) focused exclusively on client projects. We offer customized full-service solutions for bioprocess development and the production of complex biopharmaceuticals. As a German family-owned company with an international footprint and global reach, we combine experts, expertise and years of experience to develop best-in-class solutions – together with our clients. Rentschler Biopharma has approximately 1,400 employees and is headquartered in Laupheim, Germany, with a site in Milford, MA, USA. In 2024, we joined the United Nations Global Compact, underlining our commitment to sustainability. As an independent family-owned company, we live by the motto: Many hands, many minds - ONE TEAM! Open, respectful cooperation characterizes our working environment, where quality awareness, diligence and responsibility are our top priorities. With all the diversity of our talents in the Rentschler team, we pursue one vision together: advancing medicine to save lives. We are seeking a proactive, strategic, and “hands-on” External Quality Assurance Associate II who demonstrates the flexibility and adaptability necessary in a fast paced, rapidly changing CDMO environment. This self-motivated, accountable and inquisitive individual will possess strong organizational and communication skills with the ability to multi-task and deliver industry-leading customer service. As part of the Quality Assurance team supporting a multi-product CDMO facility, the External Quality Assurance Associate II will be responsible for identifying and assessing regulatory and quality risks in the production of biological drug substances and in compliance with regulatory agency rules and company quality practices. The role may need to assess operations in real time in the manufacturing areas and maintains a high level of expertise in current regulatory requirements, serving as a plant resource for compliance to GMP requirements.

Requirements

• Bachelor’s Degree in STEM
• 3+ years of experience in the Quality function within a biotech or pharmaceutical company or other similarly regulated industry
• Knowledge of FDA cGMP regulatory requirements as they apply in a biologics manufacturing environment
• Knowledge of manufacturing processes and the impact of deviations on the quality of the product
• Experience with 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

Nice To Haves

• 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

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 Quality representative of new product introduction for the Quality organization by reviewing and approving technical documents such as, engineering, validation, stability, development studies, etc
• Assist in the writing, reviewing, analyzing and revision of written Standard Operating Procedures (SOPs) and submit procedural changes as needed to meet Corporate, Site and other regulatory requirements
• Participate in continuous improvement initiatives within the department and site wide
• Provide support in the training of 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level