We are seeking an experienced Incoming Raw Material Inspector to support a biopharmaceutical manufacturing operation. This position is responsible for receiving, inspecting, documenting, and releasing incoming raw materials, components, packaging, and supplies in accordance with GMP, SOPs, and quality standards.
Candidates must have previous experience in GMP-regulated biopharma, pharmaceutical, food manufacturing, or a similar regulated manufacturing environment. Experience performing incoming inspection or quality inspections of raw materials is strongly preferred.
Key Responsibilities
- Perform incoming inspection of raw materials, components, packaging materials, and supplies.
- Verify materials against purchase orders, specifications, certificates of analysis (COAs), packing lists, and approved documentation.
- Inspect materials for identity, quantity, condition, labeling, lot numbers, expiration dates, and damage.
- Verify proper documentation and traceability for incoming materials.
- Enter inspection and receiving information accurately into ERP, inventory, or quality systems.
- Place materials on appropriate quarantine, released, or rejected status based on established procedures.
- Identify and document discrepancies, damaged materials, labeling issues, or specification concerns.
- Support material sampling activities in accordance with approved SOPs and GMP requirements.
- Maintain accurate inspection records and complete required documentation.
- Follow Good Manufacturing Practices (GMP), safety procedures, and company SOPs.
- Work closely with Quality, Warehouse, Supply Chain, Purchasing, and Manufacturing teams.
- Assist with investigations, nonconformances, deviations, and corrective actions when necessary.
- Maintain a clean, organized, and compliant work area.
- Perform other quality and material-control duties as assigned.
Required Qualifications
- Previous experience in GMP biopharmaceutical, pharmaceutical, food manufacturing, medical device, or other regulated manufacturing environments.
- Previous experience with incoming inspection, receiving inspection, quality inspection, or raw material inspection.
- Understanding of GMP requirements, SOPs, documentation practices, and material traceability.
- Strong attention to detail and ability to identify discrepancies.
- Ability to accurately read and verify documentation, labels, lot numbers, quantities, and specifications.
- Basic computer skills and experience entering information into ERP, inventory, or quality systems.
- Strong organizational and communication skills.
- Ability to follow detailed procedures and maintain accurate records.
Preferred Qualifications
- Experience inspecting biopharmaceutical or pharmaceutical raw materials.
- Experience reviewing Certificates of Analysis (COAs) and supplier documentation.
- Experience with SAP, ERP, LIMS, or electronic quality systems.
- Experience with sampling, quarantine/release processes, nonconformances, deviations, or CAPA.
- Experience in a GMP food manufacturing environment will be considered relevant.
- Knowledge of FDA-regulated manufacturing requirements.
Education
- High school diploma or equivalent required.
- Associate or Bachelor’s degree in Biology, Chemistry, Biochemistry, Food Science, Pharmaceutical Science, or a related field is preferred.
- Manufacturing/warehouse/quality environment.
- May require standing, walking, lifting, and moving raw material containers.
- Must be comfortable working in a GMP-regulated environment and following gowning and hygiene requirements when applicable.