QC Associate II, Raw Materials - NorwoodApply Now
Location: Norwood, Massachusetts
Employment Type: Contract
Job Description
Title: QC Associate II – Raw Materials
Location: Norwood, MA
Work Arrangement: 100% Onsite
Employment Type: Contract
Duration: 6+ months
About the Role
We are seeking a QC Associate II to support cGMP Quality Control testing for raw materials, drug substances, and finished products in a regulated manufacturing environment.
This role will perform and troubleshoot molecular biology, cell-based, potency, and protein analysis methods while supporting method transfers, qualification activities, laboratory operations, and GMP documentation.
Key Responsibilities
Key Skills
Quality Control | cGMP | Mammalian Cell Culture | Cell-Based Assays | Potency Assays | ELISA | qPCR | Molecular Biology | Protein Analysis | Method Qualification | CAPA | GMP Documentation
Compensation
In accordance with applicable pay transparency requirements, the anticipated hourly rate for this role is $35.00–$40.00/hr, based on experience and qualifications.
Location: Norwood, MA
Work Arrangement: 100% Onsite
Employment Type: Contract
Duration: 6+ months
About the Role
We are seeking a QC Associate II to support cGMP Quality Control testing for raw materials, drug substances, and finished products in a regulated manufacturing environment.
This role will perform and troubleshoot molecular biology, cell-based, potency, and protein analysis methods while supporting method transfers, qualification activities, laboratory operations, and GMP documentation.
Key Responsibilities
- Execute QC molecular biology and bioassay methods, including mammalian cell-based potency assays, qPCR, sequencing, and protein analysis
- Perform hands-on mammalian cell culture, cell-based assays, ELISA, and related laboratory testing
- Troubleshoot assay, instrumentation, and equipment issues
- Support method transfer, qualification, and continuous improvement activities
- Prepare reagents and perform general laboratory activities including equipment maintenance, housekeeping, and logbook review
- Write and revise SOPs, protocols, reports, and other controlled documentation
- Support investigations, change controls, CAPAs, audits, and other Quality activities while ensuring cGMP compliance
- Bachelor's degree in a STEM discipline
- 3–5 years of experience in a cGMP laboratory environment
- Hands-on experience with mammalian cell culture
- Experience with cell-based and potency assays
- Experience with ELISA, molecular biology methods, and protein analysis
- Strong understanding of cGMP laboratory documentation and regulatory requirements
- Ability to troubleshoot analytical methods and laboratory equipment
- Ability to work effectively in a fast-paced, cross-functional environment
- Experience with method development or qualification for molecular biology, cell-based, or protein analysis methods
- Aseptic technique experience
- Experience working in a Biological Safety Cabinet
- Experience preparing reagents and pipetting small volumes
- Familiarity with laboratory equipment such as pH meters, balances, and pipettes
- Experience with laboratory equipment calibration and maintenance
- Familiarity with FDA, EU, and ICH guidelines
Key Skills
Quality Control | cGMP | Mammalian Cell Culture | Cell-Based Assays | Potency Assays | ELISA | qPCR | Molecular Biology | Protein Analysis | Method Qualification | CAPA | GMP Documentation
Compensation
In accordance with applicable pay transparency requirements, the anticipated hourly rate for this role is $35.00–$40.00/hr, based on experience and qualifications.
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