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Quality Assurance Specialist

2 months ago

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

Job Summary:

We are seeking a Quality Control Raw Materials Associate I to join our team at Randstad Life Sciences US. This role will be responsible for performing QC Raw Material activities in support of GMP Manufacturing and special projects.

Key Responsibilities:

  • Requesting, sampling, and shipping of raw materials
  • Sample coordination including cross-functional collaboration with internal and external labs
  • Supporting domestic and international sample shipments
  • Supporting testing for methods including pH, conductivity, TruScan RM spectroscopy, appearance, and dimensional verification
  • Inspecting product and raw material retain samples
  • LIMS (LabVantage) sample logging and result entry
  • Raw material and consumable component inspection and release
  • Clean room gowning and aseptic techniques
  • Managing/stocking of QC lab supplies and routine lab cleaning
  • Completing and maintaining cGMP documentation for work performed
  • Maintaining a safe laboratory working environment
  • Fostering a positive and inclusive work culture that promotes collaboration, innovation, and continuous improvement
  • Following all relevant GxP regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements
  • Executing tasks precisely as defined in internal guiding documents including but not limited to standard operating procedures (SOPs) and work instructions
  • Following Good Documentation Practices and Data Integrity requirements to ensure data, documentation, and records are completed and maintained for use by the business and available to support audits or inspections
  • Completing training in assigned required learning plan according to the defined timing and the prescribed requalification cadence

Requirements:

  • BA/BS in a relevant scientific discipline
  • 0-2 years or 3+ years in a GMP QC laboratory setting
  • Demonstrated aptitude or ability to learn in order to gain a strong understanding of GxP regulations