Integrated Resources, Inc
4 days ago
Title- Bench Scientist
Location-Sanford, NC
Duration- 18+ months
Schedule:
2nd Shift
3p-11:30p
M-F
JOB DESCRIPTION:
- The position will support the Quality Operations department by performing Quality Control activities associated with clinical and/or commercial products, raw materials, validation, and stability.
- Key responsibilities are performing GMP tasks associated with maintaining compliant Quality Control and Stability laboratories; providing sample management support for QC; and creating, reviewing and approving documentation.
- Responsible for supporting the sample management process for QC (pick up from manufacturing, maintaining chain of custody in LIMS, aliquoting/delivering samples to appropriate lab, etc)
- Acts safely and follows all EH&S safety requirements for site and QC laboratories with sufficient depth of knowledge within their scientific discipline and previous area of experience good written and verbal communication techniques.
- Able to create, review, and approve test methods and/or equipment validation records with limited guidance/coaching.
- Experience assisting with laboratory investigations to define root cause and assisting with validation protocol non-conformances method 1, yellow belt trained and/or understands use of tools and can apply them to solve issues (including technical issues).
- Able to review working instructions for technical content within own subject area and reference to applicable GMPs and regulatory expectations, make value-added comments.
- Individual should have knowledge of current Good Manufacturing Practices (cGMP), Laboratory Information Management System (LIMS), Microsoft Office™ applications specifically Word and Excel, analytical techniques and instrumentation, Lean Six Sigma concepts, and Lean Labs.
Hard Skills:
- FDA / GMP Compliance
- GDP Documentation
Preferred Skills:
- Labware LIMS
- Sample management and handling
What is the minimum education experience required: Bioworks Certification with 2+ years of experience OR Bachelor's.
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