Job Title: Manufacturing Quality Assurance Specialist (MQA Specialist)
Job Overview: Responsible for the quality oversight and assistance to Production processes, supporting departments, and labs. review of all finished product documentation and ensure compliance with cGMP, SOP's, and FDA regulations, for release of product. Provide recommendations and resolutions to take appropriate action to ensure compliance.
- 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.
- BS in science discipline preferred, or High School diploma with 3+ years of experience or knowledge in a GMP-regulated industry.
- Experience working in a Production/Manufacturing area.
- Strong computer knowledge.
- Qualifies as a Visual Inspector to perform AQL inspections.
- Proven communication (oral and written) and proofreading skills.
- Prior troubleshooting, auditing of production documentation and QC experience a plus.
- SPC software knowledge a plus.
- Pharmaceutical experience a plus.
- Previously worked in Quality, Manufacturing, and/or with batch records.
Key Skills: Manufacturing, Quality Control, GMP, Pharmaceutical, SPC, Batches, SOP's, Visual Inspection, Chemicals, FDA, Protocols, CAPA