The Quality Control Analyst II plays a key role in ensuring quality and compliance throughout the product lifecycle, from development to commercialization. This position involves executing both routine and complex testing, supporting method transfers, and contributing to laboratory operations. Located primarily in Norton, MA, with occasional responsibilities in Cambridge, MA, the role ensures timely and efficient quality control operations aligned with organizational goals.

Duties & Responsibilities:

• Perform routine and non-routine analytical and microbiological testing for raw materials, in-process samples, product releases, and stability studies per established SOPs.
• Maintain training records and adhere to schedules, ensuring timely completion of assignments and alignment with project timelines.
• Assist in laboratory maintenance, including equipment upkeep, reagent preparation, and inventory management.
• Review and submit data in a timely manner, contributing to data verification for regulatory submissions as required.
• Participate in method transfers, qualifications, validations, and operational testing assignments.
• Revise and update controlled documents (e.g., SOPs, work instructions, and test methods) to support continuous improvement and compliance.
• Ensure compliance with internal standards, GMP, GLP, and industry guidelines (e.g., ICH).
• Collaborate with cross-functional teams (e.g., Manufacturing, Materials Management, Quality Assurance) to support seamless QC operations.
• Assist with inspection readiness activities, supporting audits and inspections as needed.
• Participate in continuous improvement initiatives to enhance QC processes and laboratory efficiency.
• Pursue ongoing training and development to maintain expertise in testing techniques and regulatory compliance.

Skills & Qualifications:

• Proficient in analytical and microbiological assay execution, with a focus on raw materials, in-process samples, and product testing.
• Experienced in laboratory operations, including equipment maintenance and sample preparation.
• Strong understanding of regulatory standards (GMP, GLP, ICH guidelines).
• Excellent documentation skills with attention to detail and data integrity.
• Ability to collaborate effectively across departments and support cross-functional objectives.

Requirements

Education & Experience:

• Bachelor’s degree in chemistry, biology, biochemistry, or a related field preferred.
• Associates Degree, Biotech Certificate, or equivalent considered.
• Minimum 2 years of experience in a regulated laboratory setting (Pharmaceutical/Biotech industry preferred).