GMP Raw Material Sampling Specialist

Lever, Inc.; Bristol Township (Bucks County); On-site; USD 52,000 - 78,000; Full time

Job summary

Abzena is seeking a Raw Material Sampling Coordinator to manage controlled sampling of incoming GMP raw materials and ensure timely transfer to QC for testing and disposition. You will collaborate across Materials Management, QC, and Manufacturing to support material release and manufacturing readiness.

The role requires knowledge of cGMP, GMP documentation, and chain of custody, with experience in ERP/LIMS systems and a willingness to travel between Abzena sites to support operations and audits.

Qualifications

• High school diploma or equivalent required; degrees preferred in Chemistry, Biology, Pharmaceutical Sciences, Life Sciences, or related field.
• 2+ years of experience in regulated operations (pharmaceutical/biotech/lab/warehouse) with GMP sampling experience preferred.
• Working knowledge of cGMP requirements, good documentation practices, material status control, traceability, and contamination prevention.
• Hands-on experience with raw material sampling tools, balances, sampling booths, biological safety cabinets, or controlled environments preferred.
• Ability to follow material specifications, SOPs, safety data sheets, and work instructions with high accuracy.
• Experience with ERP/MRP and LIMS systems; SAP or similar systems a plus.
• Experience handling temperature-sensitive, hazardous, or controlled materials and use of PPE as required.
• Strong attention to detail and ability to maintain GMP documentation.
• Ability to identify discrepancies, stop work when conditions are not acceptable, and escalate concerns promptly.
• Strong organizational and collaboration skills to coordinate with QC and Materials Management.
• Willingness to travel between Abzena sites (Bristol PA, San Diego CA, Cambridge UK) as needed.

Responsibilities

• Review incoming material receipt documentation, status, lot information, container counts, and sampling requirements before starting sampling.
• Coordinate daily raw material sampling priorities with Materials Management, QC, Supply Chain, and Manufacturing to support release and readiness.
• Inspect incoming containers for identity, labeling, seal integrity, damage, cleanliness, and other conditions that could affect sampling.
• Stage quarantined materials in approved locations while maintaining segregation and traceability.
• Perform representative sampling using approved procedures, tools, equipment, and PPE to minimize contamination.
• Label containers and document sample identity, material code, supplier lot, and sampling details.
• Maintain chain of custody and ensure timely delivery to QC or testing labs.
• Complete ERP/LIMS transactions accurately; ensure data integrity and proper documentation.
• Return sampled source containers to correct quarantine or storage with maintained status.
• Support deviations, investigations, CAPAs, change controls, and quality records related to sampling.

Skills

cGMP knowledge

Good documentation

Sampling

Traceability

Material handling

Communication

Independent work

Education

Associate's or Bachelor's degree in Chemistry/Biology/Pharmaceutical Sciences/Life Sciences

Tools

ERP/MRP systems

LIMS

SAP

IFRS/IFS (plus)

Job description

Abzena is seeking a Raw Material Sampling Coordinator to manage controlled sampling of incoming GMP raw materials and ensure timely transfer to QC for testing and disposition. You will collaborate across Materials Management, QC, and Manufacturing to support material release and manufacturing readiness.

The role requires knowledge of cGMP, GMP documentation, and chain of custody, with experience in ERP/LIMS systems and a willingness to travel between Abzena sites to support operations and audits.