Senior Specialist

Duties: Coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals, or registrations. Ensure timely lot disposition of product(s) for use in clinical and commercial manufacturing, packaging, and distribution. Conduct routine batch record review, batch genealogy compilation, batch disposition, and CSP notifications. Batch record review consists of executed batch records, all associated analytical data, and Quality Events. Participate in review and approval of Quality Events. Be proactive with cross-functional teams to manage/coordinate receipt, review, and approval of documentation, ensuring on-time batch disposition. Track, trend and report quality metrics as required. Effectively interact with internal multidisciplinary team members, and external contract manufacturers, to support product disposition. Work closely with departments to identify upcoming manufacturing activities and associated timelines for disposition in an effective and efficient manner. Communicate delays and work to resolve review discrepancies with manufacturing locations. Identify and communicate quality and compliance risks associated with product batches and coordinate plan to address risks. Requires a Masters degree in Life Science, Microbiology, Biotechnology, or a related field plus two years of experience in the job offered or a Biopharmaceutical occupation. Requires 1 year of experience with each of the following: 1. Batch record review and disposition; 2. CMO Management; 3. GMP Compliance; 4. Participating in internal and external audits; 5. Identifying and communicating quality and compliance risks associated with product batches and coordinating plans to address risks; 6. Working with CSP/CMO to resolve review discrepancies with their manufacturing locations; 7. Working with cross-functional teams in the review and preparation of regulatory documents and submissions, including gathering of GMP documentation. May work at additional unanticipated worksites throughout the U.S. 10% Travel may be required throughout the U.S. To Apply, please email your resume to Must reference Job to apply.