Associate II, Quality Control - Sample Management
6 Months
Norwood, MA
Hourly Pay: $35.12
3rd Shift: 10pm - 8am, Mon - Fri
Job Summary
In this role, you will perform routine sample management and support various laboratory activities at manufacturing facility. This position will focus on general lab support activities. The role involves supporting the QC operations for raw materials, drug substance, drug product, and clinical chemistry, including data management and documentation.
Job Responsibilities
- 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
- Stability
- Raw Materials
- Coordinating domestic and international sample shipments
- Communication with external Contract Test Labs (CTLs)
- Interact with Development teams in a GMP compliant manner
- 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
- Complete and maintain cGMP documentation for work performed
- Participate in authoring quality systems records such as deviations, change controls, CAPAs.
- Support non-conformance investigations
- Establish and maintain a safe laboratory working environment
Education & Qualifications
- Experience: Science coursework with 0-2 years of experience in a GMP QC laboratory setting, focusing on molecular biology, analytical chemistry, or microbiology.
- Proficiency with Microsoft Office Programs and electronic databases (LIMS, SAP).
- Excellent troubleshooting skills and the ability to communicate scientific issues clearly.
- Strong written and oral communication skills and organizational abilities.
- Knowledge of GMP, microbiology, aseptic techniques, and general laboratory instrumentation.
- Ability to work effectively in a fast-paced, cross-functional matrix environment.
- Familiarity with relevant FDA, EU, ICH guidelines, and regulations.
- A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.