Job Title: Quality Control (QC) Investigator
100% onsite in Norwood MA
Considering multiple levels of experience ($80 an hour)
Responsibilities
The QC Investigator will focus on managing and resolving quality system records and supporting cGMP compliance. Key responsibilities include:
- Quality System Records
- Own and support quality records such as deviations, CAPAs, change controls, and OOS/OOT investigations for cGMP Quality Control.
- Investigation Authoring
- Conduct investigations and author reports for Chemistry, Bioassay, and Microbiology laboratory issues.
- Document findings and root causes in accordance with cGMP standards.
- Data Analysis
- Compile and analyze metrics and KPIs for trending and process improvement.
- Documentation Management
- Author, review, and maintain equipment, methods, and laboratory procedure reports.
- Complete and manage cGMP documentation (both electronic and hard copy).
- Cross-functional Collaboration
- Partner with Quality Assurance to close records in a timely and compliant manner.
- Contribute to multi-disciplinary team initiatives for process improvement.
- Process Improvement
- Assist in identifying opportunities to enhance quality and efficiency within QC operations.
Education
- Minimum BS in a scientific discipline
- 8-10 years of experience of industry experience handling investigations