Quality Control Analyst II - Onsite, Mansfield, MA

Analyst II – Quality Control Operations Overview

The Quality Control Technical Operations Analyst II supports quality and compliance activities from development through commercialization. In addition to performing routine and non‑routine testing, this position may participate in data trending, investigations, laboratory operations, method transfers, method qualification and validation, verification, and implementation. By ensuring these activities are completed accurately and within established timelines, the Analyst II contributes to efficient and effective quality control operations.

This position is onsite and will be primarily located in Norton, MA, with occasional responsibilities at a secondary location in Cambridge, MA.

• Perform routine and non-routine analytical assays of increasing complexity to support raw materials, in-process samples, product release, and stability studies in accordance with established SOPs.
• Maintain current training records, follow testing schedules, and complete assignments on time to support laboratory operations and project timelines.
• Assist with laboratory equipment and inventory maintenance, including the preparation of reagents and samples.
• Submit data accurately and on time. May qualify as a data reviewer to support timely and efficient data availability.
• Perform role-specific operational assignments, such as raw material sampling and testing, environmental monitoring, and product testing.
• Contribute to the revision and updating of controlled documents, including SOPs, work instructions, and test methods.
• Follow internal policies, procedures, SOPs, and applicable regulatory and industry standards, including GMP, GLP, and ICH guidelines.
• Collaborate with Quality Control and cross‑functional teams to support effective laboratory and quality control operations.
• Pursue ongoing training and professional development related to QC testing techniques and regulatory compliance.
• Assist with data verification for regulatory submissions, as needed.
• Participate in inspection readiness activities and support onsite audits and inspections, as needed.
• Support continuous improvement initiatives designed to enhance QC processes, laboratory efficiency, and overall effectiveness.
• Collaborate with Manufacturing, Materials Management, Quality Assurance, and other organizational functions to support business and quality objectives.

• Bachelor's degree in chemistry, biology, biochemistry, or a related scientific field. An associate degree, biotechnology certificate, or equivalent combination of education and experience may be considered.
• Four to eight years of experience in the pharmaceutical or biotechnology industry, a regulated laboratory setting, Quality Control, or a related field.
• Data analysis experience preferred.
• Ability to work under direction with strong attention to detail in an environment where priorities may shift.
• Strong communication and teamwork skills, with the ability to work effectively in a collaborative environment.
• Familiarity with LIMS, Excel, Word, and PowerPoint is helpful.

• Medical, Prescription, Dental & Vision Benefits (for employees working 20+ hours per week)
• Health Savings Account (HSA) (for employees working 20+ hours per week)
• Life & Disability Insurance (for employees working 20+ hours per week)
• Met Life Voluntary Benefits
• Employee Assistance Program (EAP)
• 401K Retirement Savings Plan
• Direct Deposit & weekly epayroll
• Referral Bonus Programs
• Certification and training opportunities

Note:

Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All…