QC II, GMP Sample Management (3)Apply Now
Location: Cambridge, Massachusetts 02139
Employment Type: Contract
Contract Length: 6 months with possible extension or conversion
Job Summary: The individual in this role will perform cGMP QC sample management activities for QC Chemistry, Microbiology, Bioassay, and various Development labs.
- Sample coordination including cross functional collaboration with internal and external labs
- Receipt, processing, distribution and shipment of the following sample types:
- In-Process, DS, Formulation and DP
- Equipment cleaning
- Raw Materials
- Coordinating domestic and international sample shipments
- Communication with external Contract Test Labs (CTLs)
- Inspect product and raw material retention samples
- LIMS (LabVantage) sample logging and result entry
- AQL visual inspection of drug product
- Stability program support
- Controlled temperature unit management, maintenance and troubleshooting
- Clean room gowning
- Managing/stocking of QC lab supplies
- Write/revise SOPs, protocols and reports
- Minimum experience/education required: Bachelor’s degree in a relevant scientific discipline with 2+ years in a cGMP laboratory setting preferred
- Minimum knowledge required: cGMPs, general laboratory safety
- Minimum skills required:
- Pipetting, preferred to be done aseptically
- Familiarity with electronic databases (e.g. LIMS, SAP, eQMS, CMMS, LMS)
- Proficiency with Microsoft Office Programs
- Strong written and oral communication skills as well as organizational skills
- Knowledge of industry standards and guidelines
- 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.
Rich specializes in establishing new accounts and expanding current accounts, with a concentration in healthcare technology and general IT.
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