Quality Assurance Document Supervisor - Mid Shift

Summary of the Position: The Quality Assurance Documents Supervisor reports to the Quality Assurance Manager. This person supervises Quality Assurance Document Specialists. The QA Documents Supervisor supports all of the day to day operations, techniques, and activities associated with that department that are used to fulfill the Quality Assurance requirements of the product and/or service.

Roles and Responsibilities:

The QA Documents Supervisor is responsible for supervising those individuals within the QA department that perform Document Control and Batch Record Review functions.

• Initiating investigations, assessing NCRs to determine if they have the necessary information to be closed out.
• Oversee the Finished Product Update spreadsheets, including downloading the recently packaged batches from SAP and ensuring the laboratory sample receipt dates are accurate.
• Track individual reviewer metrics to determine if additional training or guidance is needed.
• Ensure cross training is performed and documented for individuals within the QA Document Specialist group.
• Establish and oversee an organized system for both buildings to meet turn-around time goals.
• Establish and oversee an organized system to track the change control process.
• Hold monthly team meetings to ensure both buildings are communicating and working together as a team.

• Perform other assigned duties as may be required in meeting company objectives
• Regular attendance is required.
• Communicate effectively with other departments within the organization and function within a team environment.

Minimum Requirements: The QA Documents Supervisor must have at least 3-5 years of experience in an FDA regulated manufacturing environment, with 3 years specifically in Quality Assurance or Quality Control. Prior FDA or equivalent inspection experience is highly recommended.

Education and Experience: A Bachelors or Associates degree with 5 years' experience in a cGMP environment related to food, dietary Supplement and/or pharmaceuticals. A high school diploma with 8 Years' experience in a cGMP environment related to food, dietary Supplement, and/or pharmaceuticals environment will be considered.

Supervisory Responsibilities: Quality Assurance staff