QC Associate, Raw Materials
Job Description
Title : QC Associate, Raw Materials I, II
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Location: Norwood, MA (On-Site)
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Employment Type: Contract
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Status: Accepting Candidates
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About the Role
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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.
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This role includes executing and troubleshooting analytical methods, supporting method transfers and qualification activities, and ensuring compliance with cGMP standards.
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Key Responsibilities
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QC Testing & Laboratory Support
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- 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
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Documentation & Quality Systems
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- 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
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Compliance & Continuous Improvement
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- Maintain mandatory training and assigned tasks
- Provide support during audits
- Collaborate on continuous improvement initiatives
- Perform additional duties as assigned
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Qualifications
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BA/BS Degree
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- STEM degree with 3–5 years of experience in a cGMP laboratory setting
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Hands-on experience with:
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- Mammalian cell culture
- Cell-based and potency assays
- ELISA
- Molecular biology
- Protein analysis
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Preferred Qualifications
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- 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
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Compensation
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- Level I: $30–$35/hr (0–2 Years Experience)
- Level II: $35–$40/hr (3–5 years' experience)
- Norwood, MA – 100% On-Site
- Monday–Friday, 8:00 AM–5:00 PM
- 6+ Month Contract
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