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Quality Assurance Inspector
1 month ago
At Argen Corporation, we are seeking a highly skilled Quality Assurance Inspector I to join our team. This role plays a pivotal part in ensuring the quality and integrity of our products.
Job SummaryThe Quality Assurance Inspector I is responsible for inspecting works in-process and finished goods in manufacturing areas to ensure conformance to ISO 13485:2016, FDA regulated standards, customer specifications, Argen requirements, and applicable procedures.
Key Responsibilities- Provides in-process/final inspection and testing as required.
- Performs visual inspections of finished products.
- Participates in internal assessments and audits as required.
- Maintains proper inspection and test records.
- Assures that non-conforming material has been properly identified.
- Advises the responsible production personnel of the acceptability of products or materials based on results of testing and/or inspection.
- Provides solutions to technical problems and assists on special projects.
- Maintains lot traceability, log sheets, and good housekeeping practices at all times.
- Maintains a working knowledge of safety policies and regulations to ensure duties of self and others are performed in a safe manner.
- Ensures that lab cleanliness and safety standards are maintained.
- Performs thorough inspections during and after the production process to ensure product quality and compliance with standards.
- Verifies that all product labeling is accurate, compliant, and meets regulatory requirements.
- Ensures that production lines are properly cleared and prepared for the next production run, maintaining cleanliness and order.
- Examines and validates DHRs to ensure all documentation is complete, accurate, and in compliance with regulatory and company standards.
- High school diploma or equivalent required.
- Previous experience working in a GMP facility a plus.
- 8 hours of Quality Training (PTC) required.
- Strong attention to detail.
- Knowledge of basic arithmetic and application to solve problems.
- Knowledge of raw materials, production processes, quality control, costs, and other techniques for maximizing the effective manufacture and distribution of goods.
- Knowledge of computer skills, administrative and office procedures and systems.
- Communicating effectively in writing as appropriate for the needs of the audience.
- Technical skills and ability to understand drawings, artworks and procedures.
- Talking to others to convey information effectively.
- Perform duties with the highest regard for safety and quality.
- Ability to understand and follow site protocols, policies and procedures.
- Must be flexible, forward-thinking, motivated, and have the ability to act independently.
- Ability to prioritize tasks and meet deadlines.
- Problem-solving skills.
- Ability to learn technical concepts by reading work instructions and standard operating procedures and completing on-the-job training.
- Knowledge of cGMP regulations ISO 13485, 21CFR Part 820, CMDR SOR/98-282, 93/42/EEC, RDC 16 2013, MHLW MO 169 and TG(MD)R Sch3 preferred.
Argen Corporation offers a comprehensive benefits package, including health plans, dental plans, vision plan, 401k with employer match, paid time off and paid holidays, employee events, wellness programs, and discounts for home, travel, entertainment, relaxation, and more.
Argen Corporation is an equal opportunity employer and welcomes applications from diverse candidates.
