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Sample Management Specialist
2 weeks ago
Quality Control - Sample Management
6 Months- temp to perm
Norwood, MA
Hourly pay: $35
Shift: 2nd Shift, 2pm - 12am Sat-Wed
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
- This position will support first shift QC Sample Management operations
- Additional duties as may be assigned from time to time
Education & Qualifications
- Education: Bachelor’s degree in a relevant scientific discipline
- Experience: At least two years in a cGMP laboratory setting
- Demonstrated aptitude or ability to learn in order to gain a strong understanding of GxP regulations.
- General laboratory operations (Pipette and analytical balance use.)
- Strong technical writing skill
- Proficiency with Microsoft Office Programs
- Quick learner with electronic databases (e.g. LIMS, SAP, LMS)
- Strong written and oral communication skills as well as organizational skills
- General knowledge of industry standards and guidelines for quality control laboratory operation
- Demonstrated ability to work effectively under established guidelines and instructions
- Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
- Be able to follow the relevant Standard Operation Procedures as written.
- Ability to efficiently prioritize and complete multiple projects and tasks in a fast-paced environment.
- A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.
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