GMP Raw Material Sampling Specialist

Abzena; Bristol Township (Bucks County); On-site; USD 42,000 - 66,000; Full time

Job summary

Abzena is seeking a Raw Material Sampling Coordinator to ensure controlled sampling of incoming GMP raw materials, maintain chain of custody, and support QC testing. You will work closely with Materials Management and Quality Control to ensure material release readiness and compliance with cGMP.

The role requires knowledge of sampling tools, ERP/LIMS systems, and the ability to operate in a regulated environment, with travel between Abzena sites as needed.

Qualifications

• High school diploma or equivalent; Associate's or Bachelor's in Chemistry, Biology, Pharmaceutical Sciences, Life Sciences, Supply Chain, or related field preferred.
• Minimum 2 years in pharmaceutical/biotech/regulated ops with GMP raw material sampling experience preferred.
• Working knowledge of cGMP, good documentation practices, chain of custody, traceability, and contamination prevention.
• Experience with raw material sampling tools, sampling booths, and controlled sampling environments preferred.
• Experience with ERP/MRP and LIMS systems; SAP or equivalents are a plus.

Responsibilities

• Support compliance with 21 CFR, cGMP, and QMS SOPs.
• Review incoming material receipt docs and sampling requirements.
• Coordinate daily raw material sampling priorities with cross-functional teams.
• Inspect containers for identity, labeling, seal integrity, and cleanliness.
• Stage quarantined materials and maintain traceability and storage conditions.
• Perform representative sampling using approved procedures and PPE.
• Label containers and document sample identity, material code, and lot information.
• Maintain chain of custody and timely delivery to QC or testing labs.
• Complete ERP/LIMS transactions with accurate data entry.
• Ensure proper resealing, relabeling, and storage after sampling.
• Support deviations, investigations, CAPAs, and change controls.
• Assist audits by providing sampling records and maintaining inspection-ready areas.

Skills

Attention to detail

Organizational skills

Communication skills

Team collaboration

Education

Bachelor's degree in Chemistry/Life Sciences

Tools

ERP/MRP

LIMS

SAP

Job description

Abzena is seeking a Raw Material Sampling Coordinator to ensure controlled sampling of incoming GMP raw materials, maintain chain of custody, and support QC testing. You will work closely with Materials Management and Quality Control to ensure material release readiness and compliance with cGMP.

The role requires knowledge of sampling tools, ERP/LIMS systems, and the ability to operate in a regulated environment, with travel between Abzena sites as needed.