Quality Assurance Supervisor – 3rd Shift
Summary of the Position: The QA Supervisor reports to the Assistant QA Manager. This person supervises Quality Assurance Generalists and label Issuance but may include other personnel in Quality Assurance Department. The QA Supervisor is responsible for all of the day to day operations, techniques, documentation, and activities associated with those departments that are used to fulfill the Quality Assurance requirements of the product and/or service. Floor presence is required to be successful in this role
Roles and Responsibilities:
- The QA supervisor is responsible for Supervising those individuals within the QA department that includes but is not limited to the following responsibilities:
- QAG and Production process monitoring
- Supports the efforts of other supervisors and Managers
- Review and approval of SOPs
- Assuring that all GMP requirements and regulations are met through compliance to government regulations, industry standards and Company policies
- Protocol review and approval
- Work with Production Supervisors to resolve production problems
- Working with Production, Regulatory Affairs, Marketing, New Product Development and other necessary departments to maintain awareness of Quality Operation activities.
- Product quality and conformance to government regulations, industry standards, and Company policies.
- Developing and deploying the Quality systems (e.g. CAPA, design control, process control) to ensure products conform to defined requirements.
- Understanding and deploying processes to assure conformance to government regulations, industry standards and Company specifications and policies.
- Conducting investigations, assessing and closing deviations, determining impact of the issues that could affect product quality, safety and purity.
- Writing and closing NCRs, review of processes, batch records, and procedures and updating when necessary.
- Must be able to effectively communicate with other departments and function within a team environment.
- Performance of other duties as assigned.
Minimum Requirements: The QA Supervisor must have at least 5 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. Knowledge of the Regulations 21 CFR 507 as well as the Dietary Supplement Regulations 21 CFR 111 is a plus
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 7 plus years in Pharmaceutical manufacturing experience will be considered
Supervisory Responsibilities: Quality Assurance staff