Job Description
Job DescriptionQUALITY ASSURANCE INSPECTORJob Summary
We are seeking a Quality Assurance Inspector to support quality assurance activities within a manufacturing environment. This position inspects products, equipment, and manufacturing and packaging areas; reviews documentation; conducts product testing and sampling; and ensures compliance with Good Manufacturing Practices (GMP) and applicable quality requirements.
Responsibilities
- Support the Quality Assurance Manager, manufacturing personnel, and supervisors with effective inspection of products, equipment, operations, and documentation.
- Review, route, and issue QA/QC documents, including batch records.
- Complete Quality Assurance logbooks as required.
- Inspect manufacturing and packaging areas in accordance with Good Manufacturing Practices (GMP).
- Ensure product quality and safety meet customer specifications.
- Check and verify equipment and instrumentation calibration.
- Support and maintain batch traceability within manufacturing and packaging areas.
- Verify product yield as reported in official documents such as Batch Production Records.
- Review logbooks, housekeeping, and QA documentation for compliance with established policies.
- Review Batch Production Records (BPR) for completeness and accuracy.
- Perform assigned testing according to Standard Operating Procedures (SOPs), including physical attribute testing such as hardness, thickness, friability, and dissolution.
- Conduct continuous daily inspections of production facilities and personnel performing GMP-related tasks.
- Conduct product sampling during the manufacturing process for microbiology and chemistry laboratory testing.
- Communicate and coordinate with QA inspectors, manufacturing and packaging personnel, warehouse personnel, supervisors, and other departments regarding GMP requirements.
- Perform other Quality Assurance functions as assigned by QA supervisors or managers.
Minimum Qualifications
- At least one year of Quality Control Analytical experience in a cGMP environment or manufacturing facility.
- Knowledge of relevant FDA regulations.
- High School Diploma or equivalent.
- Strong reasoning and analytical skills.
- Ability to distinguish between quality and defective products.
- Strong communication skills in English and Spanish.
- Basic math and analytical skills.
- Ability to communicate effectively with warehouse personnel and other departments to meet goals and deadlines.
- Ability to promote and maintain quality standards throughout the organization.