- Provide Quality Assurance oversight for manufacturing and support operations for biopharmaceutical products.
- Ensure compliance to GMP regulations for area operations and associated or support processes.
- Support investigations/deviation reports (nonconformance reports).
- Management of GMP documentation including real time manufacturing document review, approval, and archiving.
- Provide plant floor Quality oversight to maintain an inspection ready facility
- Bachelor’s Degree in Biochemistry, Biology, Chemistry, or related science field preferred.
- Demonstrated science based approach and an ability to deliver results.
- Experience working in multiple GMP databases.
- Demonstrated ability to perform GMP operations including following detailed SOPs, maintaining training, and good documentation practices.
- Experience in review and approval of batch records, NC/CAPA's and Change Control records.
- Demonstrated ability to use computer databases for query of data, managing status, and input of data and documentation.
- Previous experience in quality systems (SAP, LIMS, Change Control (CCMS), Trackwise, EDMQ, Maximo).
- Ability to focus on detail and ensure the accuracy of executed tasks and documentation per GMP standards.
- Knowledgeable of regulatory requirements/Quality Principles.
- Experience performing batch record review and previous manufacturing experience.
Ronin Staffing, LLC