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Quality Control Chemist Associate

2 months ago

Norwood, Massachusetts, United States Randstad Full time
Job Summary:

As a leading staffing and recruitment agency, Randstad is committed to finding top talent for prestigious life sciences and biopharma companies. We offer a unique opportunity for individuals to grow and learn in a dynamic environment.

Key Responsibilities:

  • Perform cGMP QC Chemistry testing for QC Chemistry, release, stability, and in-process samples.
  • Support special projects as assigned.
  • Conduct routine analytical chemistry testing, including Wet chemistry, HPLC testing, and NaOH plate reader-based assays.
  • Assist with troubleshooting assay methods and equipment.
  • Perform data entry and support trending.
  • Conduct general laboratory support activities, including reagent preparation, sample management, equipment maintenance, and lab housekeeping.
  • Support authoring of SOPs, protocols, and reports as needed.
  • LIMS (LabVantage) sample result entry and execution of Electronic Assay Forms in LIMS.
  • Stability program support.
  • Manage and stock QC lab supplies.
  • Complete and maintain cGMP documentation for work performed.
  • Participate in authoring quality systems records, such as lab events, deviations, and CAPAs as needed.
  • Establish and maintain a safe laboratory working environment.
  • Follow all relevant GxP regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements.
  • Execute tasks precisely as defined in internal guiding documents, including SOPs and work instructions.
  • Follow 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.
  • Complete training in assigned required learning plan according to the defined timing and the prescribed requalification cadence.
  • Additional duties as may be assigned from time to time.
Qualifications:
  • Education: Bachelor's degree in a relevant scientific discipline.
  • Experience: 0-2 years of laboratory experience.
  • Demonstrated aptitude or ability to learn in order to gain a strong understanding of GxP regulations.
  • A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.
Skills:
  • Quality control.
  • HPLC.
  • SOP.
  • CAPA.
  • GMP (Good Manufacturing Practice).