Biopharma QC: Raw Materials Associate II (On-Site)

Randstad USA; Norwood (MA); On-site; USD 43,000 - 56,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

401K

Short-term disability

Job summary

Randstad USA is seeking a Quality Control Associate II for our Norwood, MA site. The role supports cGMP QC testing for raw materials, drug substances, and finished products, performing method troubleshooting and transfers in a fast-paced manufacturing setting.

The position is 1st shift, Monday–Friday, with responsibilities spanning sampling, testing, QA documentation and cross-functional collaboration to ensure patient safety and regulatory compliance.

Qualifications

• BA/BS degree with 3–5 years in a cGMP laboratory setting.
• Hands-on experience in mammalian cell culture, cell-based and potency assays.
• Experience with ELISA, molecular biology and Protein Analysis.

Responsibilities

• Requesting, sampling, releasing and shipping of raw materials.
• Sample coordination with internal and external labs.
• Train and perform testing for methods including Bioanalyzer, osmolality, pH, conductivity, TruScan.
• RM spectroscopy, appearance and dimensional verification.
• Support domestic and international sample shipments.
• Inspect product and raw material retain samples.
• LIMS (LabVantage) sample logging and result entry.
• Raw material and consumable component inspection and release.
• Controlled temperature unit management, maintenance and troubleshooting.
• Clean room gowning and aseptic techniques.
• Managing/stocking of QC lab supplies and routine lab cleaning.
• Write/revise SOPs, protocols and reports.
• Complete and maintain cGMP documentation for work performed.
• Participate in authoring quality systems records such as deviations, change controls, CAPAs.
• Support non-conformance investigations.
• Establish and maintain a safe laboratory working environment.

Skills

Quality Control

Quality Assurance

cGMP

GMP

raw materials

Drug Substance

ELISA (1 year)

mammalian cell culture

molecular biology

Education

Bachelors

Job description

Randstad USA is seeking a Quality Control Associate II for our Norwood, MA site. The role supports cGMP QC testing for raw materials, drug substances, and finished products, performing method troubleshooting and transfers in a fast-paced manufacturing setting.

The position is 1st shift, Monday–Friday, with responsibilities spanning sampling, testing, QA documentation and cross-functional collaboration to ensure patient safety and regulatory compliance.