We are looking for a Raw Materials Sampler to support the Quality Control team in performing sampling, handling, documentation, storage, and issuance of raw materials and related materials in compliance with GMP, GDP, and data integrity requirements. The role ensures that materials are sampled accurately and safely to support manufacturing and quality release activities.
Key Responsibilities
- Perform sampling of raw materials, one-time-use technologies, consumables, and other materials according to approved SOPs, sampling plans, and GMP requirements.
- Use appropriate sampling tools and techniques to ensure representative samples while minimizing contamination risks.
- Label, document, segregate, and transfer samples accurately, including batch details, dates, quantities, and storage conditions.
- Conduct visual checks during sampling and report any abnormalities, discrepancies, or potential quality issues.
- Maintain sampling records, logbooks, and electronic system entries in compliance with data integrity principles.
- Support investigations related to sampling deviations, OOS results, documentation errors, or material issues.
- Follow proper gowning, hygiene, cleaning, disinfection, and contamination control practices in GMP areas.
Logistics and Warehouse Support
- Support receipt, quarantine, storage, and distribution of incoming QC samples and materials.
- Ensure samples and materials are stored under the correct conditions, such as ambient, chilled, or frozen storage.
- Coordinate outbound sample shipments to external laboratories, stability sites, or contract manufacturers when required.
- Prepare shipment documentation, packaging, and temperature-controlled materials as needed.
- Maintain inventory of sampling consumables, tools, and logistics supplies.
- Support kitting, staging, and material issuance for manufacturing and QC activities.
- Work closely with Warehouse, QC, QA, Manufacturing, and external logistics partners to ensure smooth material and sample flow.
Documentation and Systems
- Perform transactions in warehouse, inventory, or laboratory systems such as SAP, SAP EWM, LIMS, or equivalent.
- Maintain accurate and traceable records for sampling logs, inventory movements, temperature monitoring, checklists, and related documentation.
- Ensure all documentation and system updates are completed in a timely, accurate, and compliant manner.
Requirements
- Higher NITEC or Diploma in Pharmacy, Chemistry, Microbiology, Life Sciences, Biotechnology, Chemical Process Technology, or a related field.
- Minimum 2 of relevant experience in a GMP-regulated pharmaceutical, biotech, life sciences, or manufacturing environment.
- Hands-on experience in raw material sampling, sample management, materials handling, warehouse operations, or logistics support.
- Good understanding of GMP, GDP, data integrity, and basic regulatory requirements.
- Familiarity with sampling tools, aseptic practices, cleanroom operations, or contamination control will be advantageous.
- Experience using systems such as SAP, SAP EWM, LIMS, or other electronic documentation platforms will be preferred.
- Knowledge of cold-chain logistics, material quarantine, release processes, stability management, or expiry management will be an added advantage.
- Detail-oriented, safety-conscious, and able to follow procedures accurately.
- Able to work independently and collaborate with cross-functional teams.
