Bioanalytical QC Scientist - cGMP, RFT Testing & Methods

Integrated Resources, Inc ( IRI ); Plainville (MA); On-site; USD 65,000 - 90,000; Full time

Job summary

Integrated Resources, Inc. (IRI) is seeking a Bioanalytical QC Analyst to support cGMP testing in our Massachusetts laboratory.

You will perform QC testing, data review, equipment maintenance, and document control to ensure quality and regulatory compliance. Requirements include a Bachelor's degree in biology or analytical chemistry and 1–3+ years of related industry experience, plus familiarity with TOC, pH, ELISA, UHPLC, and qPCR methods.

Qualifications

• Bachelor's degree in biology, analytical chemistry, or related science.
• 1–3+ years of relevant lab experience in a GxP or bioanalytical setting.
• Experience with QC testing, method transfers, and SOPs.
• Familiarity with cGMP and quality systems; inspection readiness.

Responsibilities

• Perform cGMP QC bioanalytical testing and data review.
• Troubleshoot routine and complex assays (TOC, pH, ELISA, UHPLC, qPCR).
• Assist with method transfers, validations, and QA documentation.
• Maintain equipment, calibration, and reference standards.
• Prepare training materials and contribute to CAPAs/OOS records.
• Support audits and inspections readiness.

Skills

Communication skills

Attention to detail

Problem solving

Team collaboration

English proficiency

Safety awareness

Time management

Adaptability

Education

Bachelor's degree in biology/analytical chemistry

Tools

Empower

LIMS

TrackWise

Smartsheet

MS Office

Job description

Integrated Resources, Inc. (IRI) is seeking a Bioanalytical QC Analyst to support cGMP testing in our Massachusetts laboratory.

You will perform QC testing, data review, equipment maintenance, and document control to ensure quality and regulatory compliance. Requirements include a Bachelor's degree in biology or analytical chemistry and 1–3+ years of related industry experience, plus familiarity with TOC, pH, ELISA, UHPLC, and qPCR methods.