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OCCUPATIONAL SUMMARY:
Ensure the chemical quality of raw materials, in-process samples, finished products, and stability samples by conducting coordinating, and reporting test results and analysis in compliance with the established standards and specifications. Perform chemistry activities as related to analytical methods and product manufacturing systems to maintain cGMP compliance.
Accountabilities:
- Perform testing according to SOPs, test methods and GMP requirements.
- Notify management of OOS test results immediately.
- Ensure documentation is complete and correct and all raw data is maintained, and calculations are completed.
- Documentation review of laboratory work.
- Assist with Validation Activities as required.
Responsibilities:
- Perform a variety of testing of chemicals in compliance with established standards and specifications.
- Notify management of OOS test results immediately. Initiate OOS reports.
- Detect and report technical quality problems. Initiate Notice of Event when required.
- Day of use calibration as required.
- Maintain lab supplies. Ensure work environment is safe, clean, and organized.
- Prepare and maintain test solutions for analysis.
- Dispose of organic lab waste.
- Routine Water Testing
- Microbiological testing as required.
- Monthly instrument calibrations
- Complete standardization of solutions
- Routine Lab Audits
- Complete routine raw material testing
- Review In-Process and Finished Product testing
- Test validations samples
- Complete basic investigation testing
- Train new employees
- Perform other related duties as assigned.
QUALIFICATIONS:
- Requires the knowledge gained through a BS degree in Chemistry, Microbiology or similar and ideally a minimum of one years of experience in quality laboratory work.
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