Lab Analyst

Responsibilities:

• Compliance with all GLP/GMP and safety requirements, USP, laboratory SOP’s and Company policies and procedures. Prepare standards and sample solutions as required by the test methods.
• Performs complex procedures independently.
• Knowledge of various analytical instruments and techniques utilized in an analytical laboratory including but not limited to HPLC, GC, pH meter, IR, refractometer, Moisture Balance.
• Maintains appropriate documentation (records and lab notebooks) as required by SOP’s.
• Under supervision, identifies and communicates any potential issues to Lab Manager or designee
• Supports laboratory investigations
• May troubleshoot analytical issues that arise with guidance or independently, if able
• Support the procurement of laboratory supplies
• Ensures proper calibration and instrument calibration is performed prior to testing
• Supports Quality Policy
• May support equipment maintenance, qualification and calibration activities

Knowledge / Experience:

• A minimum of a Bachelor’s Degree is required
• A minimum of 3 years of experience in a Pharmaceutical and/or Medical Device analytical laboratory is required
• Demonstrated HPLC experience required
• Demonstrated GC experience required
• Experience with Empower & Clarity is a plus
• Working knowledge of FDA regulations for drug/device especially for the lab.
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