QC Analyst II

Job Description

Job Title: QC Analyst II

Job Description

The QC Analyst II performs routine and complex analytical testing of pharmaceutical raw materials, in-process samples, finished products, and stability samples in a small pharmaceutical laboratory setting. This role follows cGMP documentation and work instructions with precision, sets up and operates advanced analytical instrumentation, and supports the release and ongoing quality monitoring of intermediates and active pharmaceutical ingredients. The QC Analyst II works with minimal supervision, contributes to technical problem-solving and documentation, and helps ensure compliance with regulatory and internal quality standards.

Responsibilities

• Follow cGMP documentation, procedures, and work instructions accurately and completely for all laboratory activities.
• Perform routine analytical testing of pharmaceutical raw materials, in-process samples, finished products, and stability samples using established test methods and procedures.
• Execute routine laboratory functions such as weighing using balances, preparing solutions, pipetting, and using pH meters with an in-depth understanding of these core activities.
• Perform complex analyses using techniques and instrumentation including appearance testing, FT-IR, UPLC, HPLC, HPLC-ELSD, GC, and GC-HS.
• Conduct routine testing to support the release of raw materials, intermediates, and APIs, including testing for in-process controls, equipment cleaning verification, reference standard qualification, and stability programs.
• Perform and assist with the coordination of monthly or quarterly environmental monitoring testing in the laboratory.
• Coordinate and facilitate the shipment of samples to external vendors for specialized or additional testing.
• Set up and configure various analytical instruments for testing according to written test methods with little to no supervision.
• Demonstrate proficiency in operating and troubleshooting HPLC, GC, FT-IR, and related analytical equipment.
• Plan and execute analytical testing activities independently, ensuring work is completed with minimal supervision.
• Perform all assigned analyses in a timely, efficient, and organized manner to meet testing and release timelines.
• Show initiative and interest in learning new analytical techniques, methods, and tests to expand laboratory capabilities.
• Participate actively in technical discussions and brainstorming sessions to resolve issues and improve laboratory processes.
• Identify and troubleshoot analytical problems related to instrumentation, general chemistry, test methodologies, and submitted samples.
• Communicate analytical issues, challenges, and findings clearly to staff and management as needed.
• Review test data generated by other analysts and witness entries in others laboratory notebooks to support data integrity.
• Initiate, review, and assist in the completion of technical documentation such as out-of-specification (OOS) and atypical investigations, deviations, and corrective and preventive actions (CAPAs).
• Perform routine laboratory and glassware cleaning to maintain a safe, organized, and compliant work environment.
• Handle controlled substances in accordance with applicable procedures and regulatory requirements.
• Ensure timely completion of all required cGMP and other relevant company training and maintain ongoing compliance with quality and regulatory standards.

Essential Skills

• Demonstrated ability to follow cGMP documentation and work instructions accurately and completely.
• Hands-on experience performing routine analytical testing of pharmaceutical raw materials, in-process samples, finished products, and stability samples.
• Strong practical skills in core laboratory techniques including weighing and balance…