Description
We are seeking a detail-oriented Incoming Inspector to perform quality inspection, documentation, and material release activities for raw materials and components used in GMP manufacturing and packaging operations. The Incoming Inspector will ensure materials meet established specifications, internal procedures, and regulatory quality requirements while maintaining accurate documentation and traceability.
The ideal candidate will have experience in QA/QC within a regulated manufacturing environment, with hands-on experience performing inspections, documenting results, and following GMP and Good Documentation Practices (GDP).
Responsibilities
Perform incoming inspections of raw materials and components according to approved procedures, specifications, sampling plans, and quality requirements.
Conduct visual and dimensional inspections to verify materials meet established specifications.
Perform sampling of incoming materials for submission to QC laboratories for required testing.
Review inspection results and documentation to support material release or rejection.
Complete required material status identification and documentation for GMP manufacturing and packaging operations.
Process inventory and material status transactions in SAP or an equivalent ERP system.
Maintain accurate records and ensure complete traceability of inspected and released materials.
Monitor annual retain inspections and coordinate required retesting activities with Quality Control.
Complete retain inspection and retesting documentation in accordance with established procedures.
Document all activities in compliance with Good Documentation Practices (GDP) and applicable quality procedures.
Identify and communicate discrepancies, defects, or nonconforming materials.
Maintain organized inspection areas and ensure quality records are complete and accurate.
Maintain current training qualifications through classroom training, procedural review, and on-the-job training.
Follow all applicable GMP, safety, quality, and company procedures.
Qualifications
Required
Associate’s degree in Life Sciences or a related field, or equivalent combination of education and relevant work experience.
Minimum of 1 year of QA/QC experience in a regulated industry such as pharmaceutical, biotechnology, medical device, or GMP manufacturing.
Experience performing quality inspections, including dimensional and visual inspection and/or sampling activities.
Ability to accurately interpret and follow specifications, SOPs, work instructions, and quality procedures.
Strong attention to detail and ability to identify discrepancies or nonconforming materials.
Understanding of Good Documentation Practices (GDP).
Proficiency with Microsoft Office, including Word and Excel.
Strong organizational, written, and verbal communication skills.
Preferred
Bachelor’s degree in Life Sciences or a related discipline.
Experience working in a GMP manufacturing or cleanroom environment.
Experience using SAP or another ERP system in a manufacturing or quality environment.
Familiarity with ANSI Z1.4 or ISO 2859-1 sampling standards.
Experience with GD&T and dimensional inspection.
Experience using calipers, micrometers, gauges, comparators, or other inspection equipment.
Experience in pharmaceutical, biotechnology, medical device, or other FDA-regulated manufacturing environments.
Experience with material release, retain samples, laboratory testing coordination, or quality documentation systems.