Job Description

Job Description

• 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

Job Requirements

• 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.