Quality Control Operations - Analyst I

Contract position in Mansfield, MA. Join a team where precision, quality, and scientific excellence come together to help deliver safe and effective pharmaceutical products.

About the role

This is an excellent opportunity for individuals looking to grow their expertise in a regulated pharmaceutical environment as a Quality Control Operations Analyst I.

Responsibilities

• Perform routine and non-routine analytical assays to support raw materials, in-process samples, product release, and stability studies following established SOPs.
• Maintain training records, adhere to testing schedules, and ensure timely completion of assignments to meet project timelines and quality metrics.
• Assist in laboratory operations, including equipment maintenance, inventory management, and preparation of reagents and samples.
• Accurately document experimental data and observations in compliance with GxP standards.
• Participate in the review of data and contribute to the revision and updating of controlled documents such as SOPs, work instructions, and test methods.
• Adhere to internal policies, SOPs, and regulatory standards (e.g., GMP, GLP, ICH guidelines) to maintain high levels of quality and compliance.
• Identify and suggest improvements to laboratory methods and processes to enhance efficiency and reliability.
• Collaborate with cross-functional teams to ensure seamless quality control operations.
• Pursue ongoing training to deepen expertise in analytical techniques and regulatory compliance.

Requirements

• Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field.
• Familiarity with GMP/GLP-regulated laboratory environments; experience in pharmaceutical or biotechnology industries is a plus.
• Understanding of analytical techniques used in raw materials, in-process testing, release, and stability studies is preferred.
• Strong documentation skills with attention to detail and a commitment to quality and compliance.
• Basic awareness of regulatory guidelines relevant to pharmaceutical QC (e.g., GMP, GLP, ICH).
• Effective communication and teamwork skills with the ability to collaborate across functions.
• Ability to work under supervision and follow detailed instructions.