Clinical QA Supervisor
Our client in Philadelphia is looking for a Clinical QA Supervisor.
BASIC FUNCTION: Responsible for supervising QA Inspectors on two shifts in their daily activities and performing QA auditing activities in the Clinical Services Group. The position requires the ability to carry out delegated auditing activities, supervise and organize work activities of all inspectors to ensure a timely turnaround on projects, problem solve and train others. SPECIFIC DUTIES, ACTIVITIES, AND RESPONSIBILITIES: Supervise daily activities of the QA Inspectors ensuring compliance with cGMPs, Clinical Services Operating procedures and batch records.
Develop, implement and maintain Clinical Services SOPs and Operating Procedures as required to comply with cGMPs.
Responsible for scheduling of QA Inspectors to ensure production rooms are properly covered for hourly inspections; first, second and overtime shifts.
Work closely with production and clinical project management to resolve problems; be the laison between the PM dept. and the Inspectors. Identify issues within the facility and help implement corrective action(s).
Assist with internal investigations to address customer complaints and resolve quality issues.
Assist in customer and regulatory audits.
Assisting in troubleshooting on production floor.
Leading weekly QA meetings on training and quality issues.
Communication of results to QA Manager.
Assist in training all staff.
POSITION REQUIREMENTS: In-depth knowledge and experience with FDA regulations.
Supervisory experience required.
Possess above average written, verbal and interpersonal communication skills.
Above average math and statistical skills.
Teaching and training experience in cGMPs preferred.
REPORTS TO: QA Manager SUPERVISES (BOTH FIRST AND SECOND SHIFT) -2 Lead QA Inspectors -6-8 QA Inspectors EDUCATION: BS in Pharmacy, Chemistry, Biology or Health Related Service or 2-4 years industry experience EXPERIENCE OR EQUIVALENT: 2+ Years Experience in the Pharmaceutical Industry Click Here To Apply
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