Quality Management Specialist II

United Pharma; New Jersey; On-site; USD 70,000 - 90,000; Full time

Job summary

United Pharma is looking for a Quality Management Specialist in New Jersey to support batch record review, product release, and quality operations for pharmaceutical products. The ideal candidate will have over 5 years of QA/QC experience and a strong background in batch release processes. Key responsibilities include managing quality events, reviewing investigations, and ensuring compliance with GMP regulations. A Bachelor's degree in Chemistry or a related field is required, and familiarity with TrackWise is preferred.

Qualifications

• 5+ years of QA/QC or pharmaceutical manufacturing experience.
• Strong batch review and release experience.
• Experience with TrackWise or similar QMS tools.

Responsibilities

• Perform batch record review to support product release activities.
• Manage quality events, deviations, change controls, and CAPA in TrackWise.
• Ensure compliance with GMP regulations and internal quality standards.

Skills

QA/QC experience

Batch review and release

TrackWise/QMS tools

FDA regulations knowledge

Biologics or monoclonal antibodies

Education

Bachelor’s degree in Chemistry, Biology, or related science

Tools

TrackWise

Job description

Seeking a Quality Management Specialist to support batch record review, product release, and quality operations for commercial and clinical pharmaceutical products.

Responsibilities

• Perform batch record review to support product release activities
• Manage quality events, deviations, change controls, and CAPA in TrackWise
• Review investigations, root cause analysis, OOS, and analytical documentation
• Support creation and maintenance of specifications, BOMs, and Master Batch Records
• Collaborate with Technical Operations, QA, QC, and external partners
• Identify trends and maintain quality trackers during batch review
• Ensure compliance with GMP regulations and internal quality standards

Qualifications

• 5+ years of QA/QC or pharmaceutical manufacturing experience
• Strong batch review and release experience
• Experience with TrackWise or similar QMS tools
• Knowledge of FDA 21 CFR Parts 210 & 211 and GMP requirements
• Biologics or monoclonal antibody experience preferred
• Bachelor’s degree in Chemistry, Biology, or related science