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Randstad USA

Quality Control Associate II

Randstad USA, Norwood, Massachusetts, us, 02062

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Base pay range $35.00/hr - $48.00/hr

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Compensation: Up to $48.00/hr

Managed By: Randstad (Contract Position)

The Opportunity Randstad is seeking a dedicated and experienced Quality Control Associate II to join the Chemistry laboratory team at a leading pharmaceutical client in Norwood, MA. This pivotal contract position offers the chance to apply your cGMP analytical expertise in a fast-paced manufacturing environment. You will be instrumental in ensuring the quality, compliance, and timely release of critical drug substance and drug products. This unique Sunday–Wednesday schedule provides a focused, four-day work week.

Here’s What You’ll Do

Perform Core Testing: Routinely execute in-process, release, and stability testing for raw materials, drug substance, intermediates, and drug products in accordance with cGMP, SOP, FDA, ICH, and other regulatory requirements.

Utilize Advanced Equipment: Routinely use analytical equipment including, but not limited to HPLC, UPLC, UV plate reader, particulate matter, Dynamic Light Scattering (for particle size analysis), KF, and Osmolality, etc.

Maintain Documentation: Meticulously document all testing procedures and results using Assay Performance Worksheets and/or LIMS as per GDP (Good Documentation Practices), and submit data packets for review.

Ensure Compliance: Maintain compliance to data integrity and cGMP in the QC lab in line with FDA and ICH guidance.

Support Investigations: Be involved in lab investigations for OOS, OOT, OOE, and deviation investigations. May also assist with troubleshooting assay methods/equipment and implementing CAPAs.

General Lab Support: Perform necessary lab support activities, including reagent preparation, sample management, equipment maintenance, lab housekeeping and 5S activities, etc.

Documentation Support: Review, write, or revise SOPs, protocols, and reports.

Here’s What You’ll Need (Basic Qualifications)

Education: BA/BS in Chemistry (preferred) or other relevant scientific discipline.

Experience: At least two years of working experience in a quality control laboratory in a pharmaceutical company.

Regulatory Knowledge: Demonstrated ability to work under cGMP regulations and follow current test methods and/or protocols.

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