Job description:
- 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.
Qualifications:
Bachelors or Associates degree with 5 years' experience in a cGMP environment
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.
Why is This a Great Opportunity:
Stable company with growth potential.