Senior Quality Control Analyst

Quality Control Associate II – Molecular Biology & Bioassays

We are seeking a motivated Quality Control Associate II to support molecular biology and bioassay testing within a regulated laboratory environment. This individual will play a key role in executing QC assays, maintaining laboratory operations, supporting investigations, and ensuring compliance with GMP quality standards. The ideal candidate will have experience in molecular biology techniques, mammalian cell culture, potency assays, and QC testing within a pharmaceutical, biotechnology, or life sciences setting.

Key Responsibilities:

• Perform routine quality control testing using molecular biology and bioassay methods, including:
• qPCR
• Mammalian cell-based potency assays
• DNA sequencing
• Protein analysis techniques
• Execute raw material, in-process, and drug product testing according to approved methods and procedures.
• Assist with troubleshooting assay performance, equipment issues, and laboratory investigations.
• Prepare reagents, standards, media, and other laboratory materials required for testing activities.
• Support general laboratory operations, including equipment maintenance, housekeeping, calibration activities, and logbook review.
• Author, revise, and maintain laboratory documentation, including SOPs, protocols, technical reports, and controlled records.
• Support quality system activities such as investigations, change controls, deviations, and CAPAs.
• Maintain accurate documentation in accordance with GMP requirements.
• Participate in internal and external audits and contribute to continuous improvement initiatives.
• Collaborate effectively with Quality, Manufacturing, Analytical Development, and other cross-functional teams.

Required Qualifications:

• Bachelor's degree in Biology, Molecular Biology, Biochemistry, Biotechnology, or a related Life Science discipline.
• 3-5 years of experience in a cGMP laboratory environment.
• Hands-on experience with mammalian cell culture and cell-based potency assays.
• Experience performing molecular biology techniques, including qPCR and sequencing.
• Experience with protein analysis methods such as ELISA and related biochemical assays.
• Strong understanding of GMP documentation practices and quality systems.

Preferred Qualifications:

• Experience with method development, optimization, qualification, or transfer activities.
• Experience supporting investigations, CAPAs, and change controls.
• Familiarity with raw material testing and release processes.
• Experience working with drug products in a regulated pharmaceutical or biotechnology environment.

Technical

Skills:

• Mammalian Cell Culture
• Cell-Based Potency Assays
• qPCR
• DNA Sequencing
• ELISA
• Protein Analysis
• GMP Documentation
• Raw Material Testing
• Reagent Preparation
• Laboratory Equipment Calibration & Maintenance
• Aseptic Technique
• Biological Safety Cabinet (BSC) Operations

Job Type &

Location:

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

Pay and Benefits:

The pay range for this position is $34.00 - $39.00/hr individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms.

If eligible, the benefits available for this temporary role may include the following:
Medical, dental & vision;
Critical Illness, Accident, and Hospital; 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available;
Life Insurance (Voluntary Life & AD&D for the employee and dependents);
Short and long-term disability;
Health Spending Account (HSA);
Transportation benefits;
Employee Assistance Program;
Time Off/Leave (PTO, Vacation or Sick Leave).

Workplace Type:

This is a fully onsite position in Norwood, MA.

Final date to receive applications:

This position is anticipated to close on Sep 8, 2026.