POSITION SUMMARY Position is responsible for quality oversight and assistance to production processes, supporting departments and laboratories. Position recommends corrective action in responsible to deviations noted. Assures compliance to SOP's and GMP's. Maintains the finished product reserve appropriate sampling and FDA retention sample storage areas.
PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT
- Performs reviews of all operating processes and participates in internal quality assurance for the operations and facility. Will perform record reviews while on the production floor.
- Recognizes opportunities for improvement and compliance and immediately communicates them to production colleagues and MQA Supervision. Directly participates in corrective actions of critical, major or minor deviations found.
- Performs analysis of fill operations utilizing Statistical Process Control software.
- Gown qualifies for Aseptic and Terminal Sterilization processes. Qualifies as a Visual Inspector for performing AQL inspections, subject to on-going qualification training/ testing.
- Reviews manufacturing compounding of drug products for verification.
- Assures line clearances and appropriate quality assurance procedures within the packaging areas.
- Will be the cGMP "go to person" on the production floor.
- Responsible to see that all operations on the production floor are being performed as required by written procedures and participates in the writing and approval of these procedures. Assures critical steps have been performed as directed in SOPs and batch records.
- Demonstrates knowledge of production and support departments via the ability to perform, review and audit operations.
- Assumes other duties as assigned.
- BS in Life Sciences preferred or High School diploma with previous related field experience or knowledge of a GMP - regulated industry.
- Minimum of High School Diploma with 3-5 years of related experience required.
- Broad production knowledge a plus.
- Computer knowledge a must. Knowledge of Word/Access and Excel applications a plus