Chemistry Laboratory Analyst (CO, Golden)

Responsibilities

• Carry out analytical testing according to Standard Operating Procedures (SOPs) and regulatory requirements, including potency, material identification, particulate and dissolution.
• Maintain daily logs for laboratory areas, equipment, and utensils.
• Perform routine preventative maintenance on laboratory equipment to ensure accurate results.
• Prepare Certificates of Analysis for Quality review.
• Enter and organize data, perform trend analysis, and maintain records.
• Support in drafting and reviewing procedures, change controls, risk assessments, deviations, and Corrective Action Preventive Action (CAPA).
• Participate in test method and equipment validations.
• Absorb compliance with federal and state laws, as well as company standards and specifications.
• Assist the Laboratory Manager as needed.

Qualifications

• A Bachelor’s degree in science is preferred or equivalent experience in the field.
• Minimum 1 year experience in a GMP pharmaceutical testing lab required.
• Experience running analytical laboratory equipment such as HPLC, FTIR, optical microscope, and chemical fume hoods.
• Experience with method validation or method transfer preferred but not required.
• Experience with dissolution testing preferred but not required.
• Experience working in a FDA regulated environment is preferred but not required.
• Good documentation and organizational skills to record lab procedures and results.
• Critical thinking and decision-making skills to evaluate assay strengths and weaknesses.
• General knowledge of qualitative and quantitative chemistry and mathematics principles.
• Familiarity with compendial testing and regulatory guidance.

Benefits

• Comprehensive health coverage.
• 401(k) with 5% match with no vesting period.
• Paid time off and holidays.
• $500 referral bonuses.
• Access to free or reduced-cost prescriptions.

Pay

Pay Range: $31-$36/hr