Analyst 1, Lab Quality Control (Multiple Openings)
- Competitive pay based on experience, night shift differential, plus an annual performance bonus.
- Full medical, dental and vision coverage, competitive 401k, HSA/FSA, and company paid Pension plan.
- 120 hours paid vacation, plus 40 hours paid sick leave and an additional 40 hours paid personal leave.
- Tuition Reimbursement for eligible degree programs.
- Set up, operate, and clean laboratory equipment used to support production of intermediate, raw material, and finished products for API, medical device raw material components, and other products as directed; complete all associated support activities in the laboratory.
- Assure that QC laboratories run in a safe, clean, and environmentally sound manner.
- Review peer laboratory data to ensure accuracy and completeness.
- Demonstrate and develop experience on HPLC, UPLC, Karl Fischer, UV analysis, NIR, and other analytical techniques and train other laboratory personnel on these techniques.
- Develop skills to troubleshoot and perform minor maintenance, calibration, and repair of laboratory instrumentation.
- Provide input on investigations (OOS, OOT, invalid assays, and other lab-related non-conformances including investigations of audit observations) as needed.
- Support the implementation of relevant CAPAs and monitor effectiveness of CAPAs.
- Carry out duties in compliance with all state and federal regulations and guidelines including FDA, ISO, EPA, OSHA, and DEA, and adheres to all company and site policies and procedures.
- Requires ability and flexibility to work weekends and overtime (on a scheduled or emergency basis) to support shift operations.
- High school diploma or two-year technical degree in a science or laboratory related field with four (4) years of Experience in a Quality Control (GMP regulated) Laboratory
- Bachelor’s or Master’s degree in Chemistry or related science degree.
- Experience applying mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlational techniques, sampling theory, and/or factor analysis.
- Experience identifying and defining problems, collecting data, establishing facts, and making scientific-based conclusions.
- Knowledgeable of FDA/EMEA regulatory requirements applicable to pharmaceuticals and medical device.
- Experience in Lab Operations and/or Quality processes/systems in a GMP Lab setting,
- Experience working with Lab Systems or processes such as eLIMs, TrackWise, Non-conformances, and/or Change Control.
- Familiarity with a variety of laboratory equipment, such as: GC, HPLC, UPLC, and/or Karl Fisher.
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