Overview
Senior Quality Assurance Specialist Jobs in Cincinnati Metropolitan Area at Germer International – Pharmaceutical Recruiting
Title: Senior Quality Assurance Specialist
Company: Germer International – Pharmaceutical Recruiting
Location: Cincinnati Metropolitan Area
Our well-established, pharmaceutical client is looking for a Senior Quality Assurance Associate to be responsible for supporting daily operations and monitoring compliance of the Oral Solid Dose (OSD) Manufacturing Area.
Apply to this ad or reach out to Jessica Goodman to learn more!
Responsibilities:
Interact with OSD Manufacturing personnel to ensure cGMP compliance and provide general guidance and support.
Review and approve SOPs, master production records, training plans, work orders, and controlled forms.
Provide input for, review, and approval of technical protocols and reports, equipment, process, and cleaning documents authored by the validation.
Review, approve, and oversee the change control process for minor change controls generated by the OSD manufacturing area including amendments and extensions.
Act as the QA Contact and QA Approver for OSD Manufacturing investigations, incidents, minor deviations, environmental excursions, and executed CAPA.
Assist in the identification of discrepancies, ensure investigations are thorough, drive to root cause, and have appropriate CAPA in place.
Able to lead exercises in root causes analysis within areas of support or cross-functionally for complex issues.
Act as QA OSD support representative on special committees and teams.
Develop metrics and other tools to measure QA OSD Support and/or systems.
Experience:
Bachelor’s degree
5+ years of Quality Assurance experience in the pharmaceutical industry
Familiarization with oral solid dose manufacturing qualification and quality
