QC Analyst II

About the role

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. This is a Contract position based out of Milford, MA.

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.