QC Data Reviewer
Norwood, MA 02062 US
Job Description The Role
In this role, you will support QC Labs with review of test records.
Heres What Youll Do
- Review executed QC test records for product release and environmental monitoring.
- Additional duties may be assigned
Heres What Youll Need (Minimum Qualifications)
- BA or BS degree in Biology, Microbiology or similar field
- 5+ years of direct experience in pharmaceutical QC Microbiology with experience in different Microbiological Assays such as Endotoxin, Sterility, Bioburden, Growth Promotion, Microbial Identification and environmental monitoring. TOC, pH and conductivity experience desired.
- Previous experience reviewing data for GDP/GMP compliance as well as audit trail review
- Previous experience managing quality records such as change controls, deviations, and lab investigations
Heres What Youll Bring to the Table (Preferred Qualifications)
- In depth understanding of compendial microbiology testing and techniques per USP, EP and JP requirements
- Experience with rapid microbiological methods
- Familiarity with electronic databases (e.g. LIMS, SAP, LMS, MODA)
- Demonstrated ability to work effectively under established guidelines and instructions
- Ability to collaborate effectively in a dynamic, cross-functional matrix environment
- Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations
- Ability to efficiently prioritize and complete multiple projects and tasks in a fast-paced environment
Sunday-Wednesday Second Shift
Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.