QC Inspector

Pay range: $23 - $24/hour

Schedule

Monday - Friday 5am - 1:30pm (2nd shift also available)

About the Role

Performs quality control inspections in all aspects of operations, checks, and tests during the manufacture of products. Inspects incoming materials and products at different stages of production. Records observations and makes recommendations for improving processes. Key responsibilities include conducting incoming, in-process, and final inspections, documenting findings, initiating nonconformance reports, supporting quality investigations, and ensuring compliance with quality standards and procedures.

Responsibilities

• Responsible for all activities involving quality inspections and compliance with applicable regulatory requirements.
• Conduct inspection and testing related to:
  • Incoming product.
  • First article.
  • In-process.
  • Final.
• Initiate nonconformance reports (NCR).
• Perform all aspects of testing related to manufacturing:
  • Incoming inspections.
  • In-process inspection.
  • Final inspection release of finished goods.
  • Document review.
• Supports cross-functional departments to investigate potential non-conformances observed.
• Ensures that all inspections and procedures are properly completed and documented.
• Perform pre and post-inspection of product 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 quality supervisor or QC lead.
• Comply with all safety requirements ensuring work areas meet standards.
• May be required to report to multiple facilities within a 2-mile radius.
• Job Order document review and release.
• Other duties as assigned.

Requirements

• High School Diploma or equivalent with 2 years of experience in quality control inspections.
• Understanding of global pharmaceutical product regulations with experience 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, maintaining training, and good documentation practices.
• Minimum of 2 years' experience with technical documentation for quality activities in pharmaceutical or medical device environments, including quality inspections and corrective actions.
• Solid organizational and planning skills.
• Ability to communicate effectively, verbally and in writing, with good interpersonal skills interdepartmentally and with external vendors and contractors.
• Ability to work effectively and efficiently in a team environment.
• Personal attributes: integrity and trust, work ethic, sound judgment, intellectual honesty, pragmatism, courage, and conviction.
• Personal accountability for results and integrity.
• Eagerness to learn and continuously improve.
• Uncompromising dedication to quality.
• Good general mathematical skills.
• General knowledge and use of measuring devices such as calipers, tape measures, rulers, pin gauges.
• General computer skills.