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QC Associate I: Chemistry

4 weeks ago

Norwood, United States Randstad Life Sciences US Full time

6 Month Contract

Norwood, MA

PR: $30-40/hour


Shifts:

WED-SAT, 2nd shift: 2:00pm-12:00am

OR

SUN-WED, 3rd shift: 10:00pm-8:00am

OR

WED-SAT, 3rd shift: 10:00pm-8:00am


In this role, you will perform cGMP QC Chemistry testing for QC Chemistry, release, stability and in process samples. This role may support special projects as needed.


Job Responsibilities

  • Performs routine analytical chemistry testing such as Wet chemistry which includes APP, Osmolarity, Particle analysis, Dynamic Light Scattering, etc.
  • Perform basic HPLC testing and NaOH plate reader-based assays in support of manufacturing process stat testing as needed
  • Supports special projects as assigned.
  • May assist with Troubleshoots assay methods and equipment.
  • Performs data entry and supports trending.
  • Performs general laboratory support activities including reagent preparation, sample management, equipment maintenance, lab housekeeping etc.
  • Supports authoring of SOPs, protocols, and reports as needed.
  • LIMS (LabVantage) sample result entry, execution of Electronic Assay Forms in LIMS
  • Stability program support
  • Managing/stocking of 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 but not limited to standard operating procedures (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


Education & Qualifications

  • Education: BA/BS in 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.