On-Site QA Specialist — GMP, MES & CAPA Expert

VetJobs; New Jersey; On-site; USD 48,000 - 58,000; Full time

Job summary

Bristol Myers Squibb in Summit West, NJ, seeks a Quality Assurance professional to oversee on-the-floor quality activities across manufacturing, labs, labeling, and supply chain. You will ensure adherence to cGMP and participate in deviations, CAPAs, and change controls.

Ideal candidates have a STEM degree with 2+ years in quality within biopharma, and are adept at problem-solving, data interpretation, and cross-functional communication in a fast-paced environment.

Qualifications

• Bachelor's degree in STEM field required or equivalent combination of education and work experience.
• 2+ years of cGMP experience with manufacturing site exposure.
• Experience with FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing.

Responsibilities

• Provide routine on-the-floor quality oversight and triage events with Manufacturing, Quality Labs, and Supply Chain.
• Interpret problems and communicate clearly to management and peers.
• Verify operations per approved MES procedures.
• Observe cleanroom and aseptic techniques during manufacturing.

Skills

Decision making

Relationship building

Problem solving

Analytical thinking

Cross-functional communication

Quality principles

Education

Bachelor's degree in STEM

2+ years cGMP experience

FDA/EMA experience

Tools

MES

SAP

LIMS

ERP

Electronic logbooks

Job description

Bristol Myers Squibb in Summit West, NJ, seeks a Quality Assurance professional to oversee on-the-floor quality activities across manufacturing, labs, labeling, and supply chain. You will ensure adherence to cGMP and participate in deviations, CAPAs, and change controls.

Ideal candidates have a STEM degree with 2+ years in quality within biopharma, and are adept at problem-solving, data interpretation, and cross-functional communication in a fast-paced environment.