Ensure compliance with cGMP legal and regulatory requirements, Client Pharma Corporate Quality Manual and Policies, and site procedures and business requirements for operational business
Requirements
- 0-3 years GMP manufacturing and/or QA related experience
- BS/BA in Biological Sciences or equivalent relevant career experience
- Electronic database system skills
- GMP knowledge
- Safety knowledge
- Ethics & Compliance knowledge
Responsibilities
- Coordinates and performs batch record issuance for internally manufactured products
- Reviews and approves manufacturing and QC related documents for raw material disposition
- Reviews and approves manufacturing and QC related documents for manufactured media
- Performs administrative functions for filing and maintenance of records between QA operations and Document Control Center
- Support cGMP and associated OJT training to QA and other departments to improve right the first time (RTFT), high quality performance
- Control costs within department to meet budget
- Complete job-related training in electronic database system along with GMP, safety, and Ethics & Compliance course requirements
Other
- BS/BA in Biological Sciences or equivalent relevant career experience
- 0-3 years GMP manufacturing and/or QA related experience
- Education: BS/BA in Biological Sciences or equivalent relevant career experience
