Quality Control Analyst

• Title: Quality Control Analyst
• Location: Norton, MA
• Duration: 12+ Months

Position Overview:

The Quality Control Analyst I will play a critical role in executing analytical assays, generating accurate and reliable data, and supporting laboratory operations to ensure the quality and compliance of products from development through commercialization.

Key Responsibilities:

• Perform routine and non-routine analytical assays supporting raw materials, in-process samples, product release, and stability studies under supervision and in accordance with established SOPs.
• Maintain current training records, follow testing schedules, and complete assignments within established timelines to support QC activities and quality metrics.
• Assist with laboratory equipment maintenance and inventory management, including preparation of reagents and samples.
• Accurately document experimental data and observations in compliance with GxP standards.
• Participate in data review commensurate with experience.
• Assist with the revision and updating of controlled documents, including SOPs, work instructions, and test methods.
• Follow internal policies, procedures, and SOPs, as well as applicable regulatory and industry standards, including GMP, GLP, and ICH guidelines.
• Participate in continuous improvement initiatives by identifying opportunities to improve laboratory methods, efficiency, and reliability.
• Collaborate with QC and cross-functional teams to support seamless laboratory operations and project goals.
• Participate in ongoing training and professional development to strengthen expertise in QC analytical techniques and regulatory compliance.

Qualifications:

• Bachelor’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field.
• 0–2 years of experience in a GMP/GLP-regulated laboratory environment; pharmaceutical or biotechnology experience preferred.
• Exposure to analytical techniques and their application to raw materials, in-process testing, product release, and stability studies preferred.
• Strong documentation skills and attention to detail with a commitment to quality and compliance.
• Basic understanding of regulatory guidelines relevant to pharmaceutical QC, including GMP, GLP, and ICH.
• Strong communication and teamwork skills with the ability to collaborate effectively across functions.
• Ability to work under supervision, follow detailed instructions, and adhere to established procedures.