Quality Control Associate I Location:

Norwood, MA 02062

Duration:

Contract Interview Process:

Virtual Interview Work Arrangement:

Onsite About the Role We are seeking a Quality Control Associate I to support GMP testing and laboratory operations within a dynamic biopharmaceutical manufacturing environment. This role will focus on molecular and cell biology laboratory activities while supporting quality control operations for raw materials, drug substances, and drug products. The ideal candidate is a detail-oriented laboratory professional with hands-on experience in molecular biology techniques, bioassays, and GMP-compliant laboratory environments. You will play a key role in ensuring product quality, maintaining laboratory readiness, and supporting documentation and compliance activities. What You'll Do Perform routine GMP bioassay and analytical testing, including: Cell-Based Potency Assays PCR and q

PCR DNA/RNA

Sequencing Gel Electrophoresis Support raw material testing and sample processing activities. Prepare reagents, buffers, and laboratory solutions according to approved procedures. Maintain laboratory equipment and ensure operational readiness. Perform routine laboratory housekeeping and organization activities. Order, receive, track, and maintain inventory of laboratory supplies and materials. Write, review, revise, and execute Standard Operating Procedures (SOPs) and laboratory protocols. Support data management activities, including scanning, organizing, and uploading records into electronic systems. Maintain accurate documentation in compliance with GMP requirements. Participate in audits, inspections, and continuous improvement initiatives. Promote and maintain a safe, clean, and compliant laboratory environment. Complete required training and assigned quality-related responsibilities. Support additional laboratory and quality control activities as needed. Minimum Qualifications Education Bachelor's degree in Biology, Molecular Biology, Biotechnology, Biochemistry, Microbiology, or another STEM-related field. Experience 1-2 years of experience in a GMP Quality Control laboratory environment. Experience supporting molecular biology workflows and/or bioassay testing. Familiarity with laboratory documentation and quality systems.

Preferred Qualifications Hands-on experience with:

Mammalian Cell Culture PCR and qPCR DNA Sequencing Gel Electrophoresis Biological Safety Cabinets (BSC) Experience preparing reagents and accurately pipetting small volumes. Knowledge of GMP regulations, aseptic techniques, and laboratory best practices. Experience using laboratory and quality management systems such as:

LIMS SAP

eQMS Familiarity with laboratory instrumentation including pH meters, balances, and pipettes. Strong troubleshooting and analytical problem-solving skills. Excellent written and verbal communication skills. Ability to work effectively in a fast-paced, cross-functional environment. Understanding of FDA, EU, and ICH regulatory guidelines and compliance requirements. Proficiency with Microsoft Office applications. Key Skills GMP Laboratory Operations Molecular Biology Techniques Bioassay Testing Cell Culture PCR/qPCR Sequencing & Electrophoresis Documentation & Data Integrity LIMS, SAP, eQMS Regulatory Compliance Scientific Troubleshooting Collaboration & Communication Medical, dental, and vision insurance are available to qualified candidates who meet eligibility requirements.