QC Inspector

Job Description

Job Summary

The Quality Control Inspector inspects materials, parts, and products at different stages of production to ensure compliance with company standards and performs various quality control inspections, checks, and tests of products during the manufacturing process.

Essential Functions

Preform activities related to quality inspections and compliance with applicable regulatory authorities.

Initiate nonconformance reports (NCR).

Record observations and make recommendations for improving processes.

Conduct inspection and testing related to:

Incoming product.

First article.

In-process.

Final.

Support cross-functional department investigations related to non-conformance findings.

Ensure all inspections and procedures are properly completed and documented.

Perform pre- and post-inspection of product as part of gamma irradiation process.

Approve or reject raw materials with respect to quality standards and communicate results to all pertinent parties.

Initiate nonconformance reports (NCR) for all non-conforming material identified throughout operations.

Prepare and submit metrics reports to the QC Supervisor or Lead.

Comply with all safety requirements ensuring work areas meet standards.

Review and release job order documents.

Wears appropriate PPE when working in ISO environment including, scrubs, coverall suit, mask, protective eyewear, gloves, shoe covers, and similar.

Recommend and participate in continuous improvement initiatives

Perform other duties as assigned

Education

High School Diploma or equivalent. Minimum 3 years of experience in quality control inspections.

Required Experience & Competencies

Understanding of global pharmaceutical product regulations with ISO 9001 and/or 13485:2003 and 21 CFR Parts 210 and 211 and/or Part 820.

Demonstrated ability to perform GMP operations following detailed SOPs, good documentation practices.

1+ years’ experience with technical documentation in the areas of quality manufacturing that includes quality inspections and corrective actions in a pharmaceutical or medical device environment.

Solid organizational and planning skills.

Excellent written and communication skills. Consistently demonstrates strong interpersonal skills in interactions across departments and with external vendors and customers.

Must be able to work effectively and efficiently in a team environment.

Able to perform all tasks with an uncompromising dedication to quality, including integrity and trust, sound judgement, intellectual honesty, pragmatism, decisiveness and conviction.

Good general mathematical skills.

General knowledge and use of measuring devices such as calipers, tape measures, rulers, pin gauges

Good computer skills.

Possesses working knowledge of ERP system, preferably Syteline

Full-time