220, East Hanover Avenue Morris Plains NJ USA 07950 Morris Plains, NJ 07950 US
- 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.
- In addition to these primary duties, provide coverage for all appropriate areas.
- Perform other job duties as assigned.
- 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 5 years of experience.
- Thorough knowledge of raw material test methods.
- Analytical chemistry knowledge to facilitate investigations.
Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.