Job #: 42731
Title: Quality Assurance Supervisor - Pharmaceuticals
Job Location: Lancaster, South Carolina - United States
Remote Job: Unknown
Salary: $60,000.00 - $80,000.00 - US Dollars - Yearly
Employer Will Recruit From: Nationwide
Relocation Paid?: Negotiable
WHY IS THIS A GREAT OPPORTUNITY? [None Listed] JOB DESCRIPTION
Roles and Responsibilities:
The assistant QA Supervisor is responsible for Supervising those individuals within the QA department that includes but is not limited to the following:
- QAG and Production process monitoring
- Assuring that all GMP requirements and regulations are met through compliance to government regulations, industry standards and Company policies
- Protocol review and approval
- Reviewing environmental conditions records and responding to excursions
- Work with Production Supervisors to resolve production problems
- Document Control
- Review and approval of SOPs
- Assuring that all applicable cGMP requirements and regulations are met through compliance to government regulations, industry standards and company policies
- Batch record documentation review and approval
- Product/Raw material/Component release (following testing)
- Working with Production, Regulatory Affairs, Marketing, New Product Development and other necessary departments to maintain awareness of Quality Systems activities.
- Product quality and conformance to government regulations, industry standards, and Company policies.
- Developing and deploying the Quality systems to ensure products conform to defined requirements.
- Understanding and deploying processes to assure conformance to government regulations, industry standards and Company policies.
- Conducting investigations, assessing and closing deviations, determining impact of the issues that could affect product quality, safety and purity.
- Reviewing customer complaints/AERs to ensure customer satisfaction and potential CAPAs are completed for nonconformance.
- Reviewing of PMs, Pest Control, Calibration records, etc.
- Must be able to effectively communicate with other departments and function within a team environment.
- Must periodically work second and third shift hours in support of personnel on those shifts.
- Performance of other duties as assigned.
Minimum Requirements: The QA Supervisor must have at least 5-7 years of experience in an FDA regulated manufacturing environment, with 5 years specifically in Quality Assurance or Quality Control. Prior FDA or equivalent inspection experience is highly recommended.
Education and Experience: BS Degree or BA Degree with a Science major or concentration and continuing education credits in the pharmaceutical industry through a reputable professional society. An Associate degree with 10 plus years in pharmaceutical manufacturing experience will be considered.
University - Bachelor`s Degree/3-4 Year Degree
How to Apply: