Type:

full-time

Job Description:

Title :

QC Associate, Raw Materials I, II Location:

Norwood, MA (On-Site)

Employment Type:

Contract Status:

Accepting Candidates About the Role The Quality Control Associate will support cGMP QC testing for raw materials, drug substances, and finished products at a manufacturing facility and affiliated contract organizations. This role includes executing and troubleshooting analytical methods, supporting method transfers and qualification activities, and ensuring compliance with cGMP standards. Key Responsibilities QC Testing & Laboratory Support Execute QC molecular biology and Bioassay methods, including mammalian cell-based potency, QPCR, sequencing, and protein analysis Assist in troubleshooting equipment and assay issues Perform reagent preparation, equipment maintenance, housekeeping, and logbook reviews Establish and maintain a safe laboratory working environment Documentation & Quality Systems Write, revise, and maintain SOPs, protocols, and reports Assist in execution of quality records, including investigations, change controls, and CAPAs Ensure compliance with cGMP documentation and regulatory guidelines Support training as assigned Compliance & Continuous Improvement Maintain mandatory training and assigned tasks Provide support during audits Collaborate on continuous improvement initiatives Perform additional duties as assigned Qualifications BA/BS Degree STEM degree with 3-5 years of experience in a cGMP laboratory setting Hands-on experience with: Mammalian cell culture Cell-based and potency assays ELISA Molecular biology Protein analysis Preferred Qualifications Method development/qualification experience with molecular biology, cell-based assays, or protein analysis methods Experience with aseptic techniques and general laboratory instrumentation Experience with pH meters, balances, and pipettes Ability to prepare reagents and pipette small volumes Experience working in a Biological Safety Cabinet Laboratory equipment calibration and maintenance experience Ability to work effectively in a fast-paced, cross-functional matrix environment Familiarity with

FDA, EU, ICH

guidelines, and regulations

Compensation Level I:

$30•35/hr (0-2 Years Experience)

Level II:

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