Proclinical is currently recruiting for a Quality Batch Review Specialist with a pharmaceutical company located in Boston, MA.
- Review batch documentation provided by contract manufacturers (CMO) and responsible for product release in accordance to procedures
- Ensure all required testing and documentation are provided and met release requirements. Including but not limited to:
- Review CMO Certificates of Conformance for batch release. Verify CMO certificates contain required information to confirm compliance of product to GMP, Quality Agreement requirements. Ensure all documents are in compliance with good documentation practice, data integrity, and accuracy of batch information, including but not limited to lot number, expiry date, within target ranges, etc..
- Ensure required Certificate of Analysis and Certificate of Conformance from bulk manufacturers and external laboratories are included and met specification.
- Ensure documentation review meets the requirements as specified for each product
- Generate Janssen certificate of release
- Maintain high level oversight of individual batch releases; able to give accurate, succinct updates on particular batch release status.
- Manage/Track CBER/ OMCL samples from CMO to final shipment to government facility.
- Generate CBER/ OMCL protocols for lot release.
- Alert Supervision of any nonconforming results, out of trend, or out of specification results.
- Support supply chain logistics for on time shipment from CMO to Warehouse
- Complete and pass all applicable training required for access to the systems
- Complete and pass all applicable training for Good Manufacturing Practice and quality requirement training
Skills and Requirements:
- Bachelor's Degree with a concentration in engineering, science, or an equivalent technical discipline
- Minimum of 4 years working in an FDA regulated environment
- Experience in pharmaceutical aseptic manufacturing operations and quality assurance
- Detailed knowledge of cGMPs related to pharmaceutical production
- Previous experience in work environment under cGMP regulation highly desirable,
- Must have strong ability to maintain high efficiencies and accuracy in data entry.
- Detail Oriented, with ability to quickly process complex information and make critical deciscions with limited information at times
- Strong interpersonal, written, and oral communication skills
- Experience in Vaccine Production/ QA
- Experience in the CBER/ OMCL process for vaccine government approval / release
- Proficient in applying process excellence tools and methodologies
- Experience working with External Manufacturers or Labs
If you are having difficulty in applying or if you have any questions, please contact Brianna Copeland at 617-830-7546.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.