Quality Assurance Specialist

2 weeks ago


Norwood, Massachusetts, United States Randstad Life Sciences US Full time

Position Title: Quality Assurance Specialist

Location: Norwood, MA

Duration: 6 Months

Role Overview:

The Quality Assurance Specialist will focus on conducting rigorous testing in the realms of molecular biology and cell culture. A minimum of 3 years of experience in a GMP environment is essential.

Key Responsibilities:

  • Conduct QC molecular biology and bioassay methodologies, including qPCR, sequencing, and protein expression.
  • Provide troubleshooting support for equipment and assay-related challenges.
  • Engage in laboratory support tasks such as reagent preparation, equipment upkeep, and maintaining laboratory cleanliness.
  • Ensure a safe and compliant laboratory environment.
  • Draft, update, and uphold standard operating procedures (SOPs), protocols, and documentation.
  • Facilitate training sessions as required.
  • Assist in managing quality records, including investigations and change controls.
  • Adhere to all relevant GxP regulations and company policies to maintain compliance with internal and regulatory standards.
  • Execute tasks in accordance with established internal guidelines, including SOPs and work instructions.
  • Maintain Good Documentation Practices and Data Integrity standards to ensure accurate data and documentation.
  • Complete required training in a timely manner and adhere to requalification schedules.
  • Additional responsibilities may be assigned as necessary.

Qualifications:

Basic Requirements:

  • Education: BA/BS Degree in a relevant field.
  • Experience: 3-5 years in a cGMP laboratory setting, with hands-on experience in molecular biology and cell-based assays.
  • Certifications: None required.

Preferred Qualifications:

  • Experience in method development and qualification for molecular biology and protein analysis.
  • Proficiency in aseptic techniques and laboratory instrumentation.
  • Ability to prepare reagents and work within a Biological Safety Cabinet.
  • Experience with calibration and maintenance of laboratory equipment.
  • Capacity to thrive in a dynamic, cross-functional environment.
  • Familiarity with FDA, EU, and ICH guidelines and regulations.
  • A commitment to contributing positively to a high-growth, transformative organization.


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