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2nd shift Sample Management Associate

2 months ago

Norwood, United States Randstad Life Sciences Full time
Job DescriptionJob Description

Immediate opportunity for a Quality Control Sample Management Associate II with a leading pharmaceutical/diagnostics company based at their Norwood, MA site, home of a state-of-the-art 200K square foot GMP manufacturing site. The Sample Management Associate II will perform cGMP QC sample management activities for QC Chemistry, Microbiology, Bioassay, and various Development labs.

Schedule Shift: 2nd shift, 2pm-12am, Wed.-Sat.; Onsite 4-5 days in Billerica until trained, then 3 days onsite. Can do a short week for summer hours.

Position Type: Contract role for 6 mos.; extension possible

Pay Rate: $25-35/hr.

Essential Duties and Responsibilities:

  • Sample coordination including cross functional collaboration with internal and external labs
  • Receipt, processing, distribution and shipment of the following sample types including: In-Process, DS, Formulation and DP; Equipment cleaning; Stability and Raw Materials
  • Coordinating domestic and international sample shipments
  • Communication with external Contract Test Labs (CTLs)
  • Interact with Development teams in a GMP compliant manner
  • Inspect product and raw material retention samples
  • LIMS (LabVantage) sample logging and result entry
  • AQL visual inspection of drug product
  • Stability program support
  • Controlled temperature unit management, maintenance and troubleshooting
  • Clean room gowning
  • Managing/stocking of QC lab supplies
  • Write/revise SOPs, protocols and reports
  • Complete and maintain cGMP documentation for work performed
  • Participate in authoring quality systems records such as deviations, change controls, CAPAs.
  • Support non-conformance investigations
  • Establish and maintain a safe laboratory working environment
  • This position will support first shift QC Sample Management operations at Moderna, Wednesday through Saturday
  • Additional duties as may be assigned from time to time

Qualifications:

  • Bachelor’s degree (BS) in a relevant scientific discipline
  • One (1) to two (2) years in a cGMP laboratory setting
  • Demonstrated aptitude or ability to learn in order to gain a strong understanding of GxP regulations.
  • General laboratory operations
  • Strong Pipetting skills required as role entails a lot of aliquoting. Pipetting and analytical balance use.
  • Strong technical writing skill
  • Proficiency with Microsoft Office Programs
  • Quick learner with electronic databases (e.g. LIMS, SAP, LMS)
  • Strong written and oral communication skills as well as organizational skills
  • General knowledge of industry standards and guidelines for quality control laboratory operation
  • Demonstrated ability to work effectively under established guidelines and instructions
  • Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
  • Be able to follow the relevant Standard Operation Procedures as written.
  • Ability to efficiently prioritize and complete multiple projects and tasks in a fast-paced environment.
  • A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.
Company DescriptionA great company doing groundbreaking and important work with a great reputation in the industryCompany DescriptionA great company doing groundbreaking and important work with a great reputation in the industry