Job Description

Position: QC Chemistry Associate II

Position Overview:

The QC Chemistry Associate II is responsible for performing both quantitative and qualitative analyses on compounded admixed pharmaceutical products distributed nationwide. This role supports quality control efforts by adhering to documentation standards and maintaining compliance with cGMP, GLP, and 21 CFR Part 11 regulations. The Associate collaborates with Chemists to develop recommendations related to product non-conformance, deviations, and investigations.

Key Responsibilities:

• Assist Chemists in evaluating chemistry data and analyzing trends in drug potency.
• Conduct investigations and experiments to assess product performance and compounding processes.
• Generate and present technical reports summarizing chemistry trends and findings.
• Support method development and validation efforts.
• Review and interpret analytical data and chromatograms.
• Recommend appropriate actions for product deviations, complaints, and non-conformances.
• Perform and oversee routine UPLC and other analytical tests on finished products, raw materials, and environmental samples.
• Ensure accurate and compliant documentation of test results in alignment with cGMP standards.
• Apply SOPs and specifications consistently during testing and review processes.
• Assist with instrument operation, troubleshooting, and maintenance.
• Prepare laboratory reagents and standards as required.
• Demonstrate proper aseptic techniques during lab procedures.
• Participate in internal and external audits, including those conducted by the FDA, DEA, and state Boards of Pharmacy.

Qualifications:

Education & Experience:

• Bachelor’s degree in Chemistry or related field
• Minimum 2 years of experience in the pharmaceutical or medical device industry
• Proficiency in chromatographic techniques (e.g., UPLC, HPLC, GC/MS)

Skills & Competencies:

• Strong understanding of cGMP, GLP, USP, and FDA regulatory requirements
• Competent in statistical analysis and its application to quality control processes
• Excellent analytical, communication, and documentation skills
• Ability to work independently and manage multiple priorities
• Familiarity with lab software for data analysis and reporting
• Detail-oriented with strong organizational and time-management skills
• Knowledge of instrumentation: UPLC, HPLC, GC/MS, ICP/MS, HPLC/MS

Physical Requirements:

• Ability to sit or stand for extended periods
• Manual dexterity to perform lab tasks (reaching, stooping, grasping)
• Capable of lifting up to 40 lbs
• Occasional travel may be required

Work Environment:

• Laboratory setting with controlled temperatures and elevated noise levels
• Required use of protective equipment and adherence to safety protocols

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