Under the supervision of the Quality Systems Supervisor, the Lead QA/QC coordinator is responsible for completing review of production documentation in a safe, quality and customer focused manner. This individual will be responsible for conducting direct documentation review within the Quality System Document Management (QSDM) department to support the on time release of products following Good Manufacturing Practices.
Key Objectives of the role:
- Upholds departmental standards as required in a GMP environment
- Reviews manufacturing and customer facing documentation for accuracy to support timely release
- Completes filing and processing of controlled documentation using production systems (such as LIMs, AGILE, Trackwise), Excel, PowerPoint and Outlook.
- Prepares customer facing documentation
- Implements change controls
- Coordinates incoming documentation to the department
- Supports regular data requests during customer audits
- Interacts with cross functional internal customers for resolution of issues
- Multi-tasks efficiently in a high-paced environment
- Effectively interacts with team members to facilitate timely resolution of isses and improve current documentation practices.
Minimum Qualifications (must have):
- High School diploma required. Associates degree with 2 years' experience in GMP environment preferred
- Minimum of 1 year degree in business or technical discipline and/or minimum of 1 year experience in a role which demonstrates attention to detail with high standards to error free work.
- Demonstrated business experience in Excel, Power Point and MS Outlook