Job at a glance
Job Title: QC Analyst II Job Description The QC Analyst II plays a key role in ensuring the quality and compliance of raw materials, in-process samples, stability samples, and finished products within a GMP-regulated environment. This position performs routine and complex analytical testing, supports method development and optimization, and maintains rigorous documentation to meet regulatory and quality standards.
The role actively promotes safe laboratory practices and contributes to continuous improvement across quality control operations. Responsibilities Demonstrate a strong commitment to laboratory safety, quality systems, and regulatory compliance in all daily operations. Support and promote a culture of safe laboratory practices by strictly following established environmental, health, and safety procedures.
Perform routine analytical and laboratory testing on raw materials, in-process samples, stability samples, and finished products. Execute testing activities in accordance with approved analytical methods, internal quality standards, and applicable regulatory requirements. Operate and maintain analytical instruments such as HPLC, Karl Fischer, UV/VIS spectrophotometers, and LCMS systems in a GMP environment.
Review and verify analytical data for accuracy, completeness, and adherence to established specifications and acceptance criteria. Document experimental results clearly and accurately in laboratory records and electronic systems, ensuring data integrity and traceability. Contribute to the preparation of technical reports, summaries, and stability assessments based on analytical data and observations.
Assist in the development, qualification, and optimization of analytical methods, protocols, and laboratory procedures. Support the creation, revision, and maintenance of controlled documentation, including standard operating procedures, test methods, and product specifications. Collaborate with cross-functional teams to investigate laboratory issues, support troubleshooting activities, and implement corrective and preventive actions.
Participate in continuous improvement initiatives to enhance laboratory efficiency, data quality, and compliance with cGMP requirements. Provide technical guidance, training, and mentorship to laboratory personnel as needed to ensure consistent application of methods and procedures. Essential Skills Bachelor’s degree (BS) in chemistry, biology, or a related scientific discipline. 2–5 years of experience as a QC analyst or chemist in a GMP or cGMP environment.
Hands-on experience with analytical testing equipment and methodologies, including High Performance Liquid Chromatography (HPLC). Practical experience with LCMS (Liquid Chromatography–Mass Spectrometry) techniques and instrumentation. Proficiency in Karl Fischer titration for moisture or water content determination. Experience with UV/VIS spectrophotometry and related analytical methods. Strong understanding of quality control principles and practices in a regulated laboratory setting.
Working knowledge of GMP and cGMP requirements and their application to laboratory operations. Ability to accurately review, interpret, and verify analytical data for compliance with specifications. Strong documentation skills with a focus on accuracy, completeness, and data integrity. Ability to follow established test methods, SOPs, and quality procedures with high attention to detail. Effective communication skills to interact with cross-functional teams and laboratory colleagues.
Additional Skills & Qualifications Experience contributing to the development, qualification, and optimization of analytical methods. Familiarity with creating, revising, and maintaining controlled documentation such as SOPs, test methods, and specifications. Experience participating in laboratory investigations, troubleshooting analytical issues, and supporting root cause analysis. Ability to provide technical guidance and on-the-job training to other laboratory personn