Quality Control Inspector

About the role

SaniSure is a high-growth multinational manufacturer of single-use products and systems used in the production of biological drugs, including cell therapies, gene therapies, and vaccines. With operations in the U.S. and Europe, we supply global pharmaceutical and biotech companies with the critical tools they need to develop and manufacture some of today's most innovative and life-changing medicines. As we continue to expand our product offerings and global footprint, SaniSure offers an exciting opportunity to join a nimble, customer-focused company at the forefront of the biotech industry.

Job Summary

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

Essential Functions

• Perform 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, and final product stages.
• 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.
• Wear 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 & Experience

• 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 ISO 13485:2003 and 21 CFR Parts 210 and 211 and/or Part 820.
• Demonstrated ability to perform GMP operations following detailed SOPs and good documentation practices.
• 1+ years of 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 verbal communication skills.
• Consistently demonstrates strong interpersonal skills in interactions across departments and with external vendors and customers.
• 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 judgment, intellectual honesty, pragmatism, decisiveness, and conviction.
• Good general mathematical skills.
• General knowledge and use of measuring devices such as calipers, tape measures, rulers, and pin gauges.
• Good computer skills.
• Possesses working knowledge of ERP systems, preferably Syteline.