Quality Assurance Specialist

2 weeks ago


Norwood, Massachusetts, United States Randstad Life Sciences Full time
Job Overview

We are seeking a skilled Quality Assurance Specialist to provide support for cGMP quality assurance testing of raw materials, drug substances, and finished products at a leading manufacturing facility. This position involves executing and troubleshooting analytical methodologies, facilitating method transfers, and ensuring adherence to cGMP standards.

Work Schedule: 1st shift, Monday to Friday.

Employment Type: Contract position for 6 months; potential for extension.

Key Responsibilities:

  • Implement QC molecular biology and bioassay techniques (e.g., qPCR, sequencing, protein expression).
  • Assist in diagnosing equipment and assay challenges.
  • Conduct general laboratory support tasks including reagent preparation, equipment upkeep, and logbook management.
  • Promote and maintain a safe laboratory environment.
  • Draft, revise, and uphold SOPs, protocols, and reports.
  • Support training initiatives as assigned.
  • Contribute to the execution of quality records (e.g., investigations, change controls, CAPAs).
  • Adhere to all relevant GxP regulations, guidelines, and company policies to ensure compliance with regulatory and internal standards.
  • Carry out tasks as specified in internal guiding documents, including standard operating procedures (SOPs) and work instructions.
  • Follow Good Documentation Practices and Data Integrity requirements to ensure data and documentation are accurately completed and maintained for business use and audit readiness.
  • Complete training as per the designated learning plan and requalification schedule.
  • Additional responsibilities may be assigned as needed.

Qualifications:

  • Bachelor's degree (BS) in Molecular and Cellular Biology, Biological Sciences, or a related discipline.
  • A minimum of three years of experience in a cGMP laboratory environment, with hands-on expertise in molecular biology and cell-based assays.
  • Experience in method development and qualification related to molecular biology, cell-based assays, or protein analysis.
  • Familiarity with techniques such as qPCR, protein expression, sequencing, cell culture, and cell passaging.
  • Trained in aseptic techniques and proficient with general laboratory instruments (e.g., pH meters, balances, pipettes).
  • Capable of preparing reagents, pipetting small volumes, and working within a Biological Safety Cabinet.
  • Experience with laboratory equipment calibration and maintenance.
  • Able to thrive in a fast-paced, cross-functional matrix environment.
  • Knowledge of relevant FDA, EU, and ICH guidelines and regulations.
  • A commitment to contributing positively as part of a high-growth, transformational organization that values boldness, relentlessness, curiosity, and collaboration.
Company Overview

A reputable organization engaged in groundbreaking and significant work within the industry.



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