Title: Compliance Specialist
Location: Framingham, MA
Pay: $30-37/hr
Contract: 12+ months
Job Description
Partner with manufacturing and support operations to ensure a culture of continuous compliance. Perform batch record review.
Job Responsibilities
- Perform quality inspections of intermediates and finished goods.
- Perform review of QC data.
- Perform logbook review.
- Provide on the floor (OTF) support to the operations department, including OTF support for critical operations
- Conduct review of testing results. Review document and complete inspection of returned goods.
- May be involved with establishing compliance requirements for the methodology transfer from
- Research to Quality Control.
- Interpret complex, explicit documentation to ensure quality standards and compliance.
- May provide training to new employees.
- Work under only very general supervision.
- Work is reviewed for soundness of judgment and overall adequacy and accuracy.
- Contribute to the completion of organizational projects and goals.
- Errors in judgment or failure to achieve results would normally require a moderate expenditure of resources to rectify.
- Represent organization on specific projects.
Education & Qualifications
Must Have: -
- Batch record review experience in a compliance role
- Excel, MS Word
- Minimum 1 year of GMP experience
- Flexibility with schedule and managing priorities
- Organized, strong communications and strong computer literacy skills
Nice to Have/ Preferred:
- Veeva, SAP
- Previous experience, gowning in GMP facility (2-3 times per week required)