Quality Control Raw Materials Scientist
220, East Hanover Avenue Morris Plains NJ USA 07950 Morris Plains, NJ 07950 US
Job Description
Major Accountabilities:
- Perform raw material testing following United States Pharmacopoeia (USP), European Pharmacopoeia (EP) and in-house methods
- Perform testing on raw materials per using HPLC, GC, UV, FTIR, NIR, wet chemistry and other techniques.
- Perform all testing and activities compliantly following appropriate SOPs and procedures.
- Review data generated by other team members.
- Review QC documents to ensure completeness, accuracy, consistency, and clarity.
- Perform quality impacting assessments and make decisions.
- Participate special projects and facilitate any issues that arise.
- Initiate change controls.
- Author validation documentation.
- Independently leads investigations of the highest complexity
- Drive complex investigations to understand root cause.
- Participate in OOS/OOE investigation
- Participate in deviation investigation/CAPA implementation in a timely manner
- Responsible for evaluating compendial updates against internal methods
- Serve as Quality Control representative on cross-functional teams.
- Knowledge of LabWare LIMS and/or other QC data systems.
- Knowledge of appropriate GMP/GLP quality systems (eSOPs, TEDI, etc.).
- Plan and schedule activities.
- Ability to lift 35lbs.
In addition to these primary duties, provide coverage for all appropriate areas.
Perform other job duties as assigned.
BACKGROUND:
- BA, or MS in biology, chemistry, biochemistry, microbiology, or other related science.
- Experience in Analytical Quality Control, method development, or a technical support function.
- At least 3 years of experience.
- Thorough knowledge of raw material test methods.
- Analytical chemistry knowledge to facilitate investigations.
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