QA Technician

Job Summary

The Quality Assurance Technician will audit Packaging finished goods and other activities within an FDA regulated environment to ensure compliance with external regulations and CooperVision's quality standards. Immediate reports of non-conformances to established SOPs; evaluates conformance using process control tools.

Responsibilities

• Performs audits including DHR (device history record) review, product label and package review, and process audits to verify conformance to established quality standards.
• Advises and works with leadership on possible improvements, reports deviations from procedures or standards to management, and participates in problem-solving sessions.
• Aids in process development, performs approved protocols, validations, and qualifications, and assists in internal audits.
• Maintains department supplies, communicates with auditing teams, retrieves DMRs for external audits, and assists in the disposition of nonconforming product.
• Trains or assists in training of new employees and performs audits on trainees to provide feedback to leadership on training progress.
• Works under minimal supervision to perform machine verification audits and report findings accurately on required forms.
• Assists in establishing product defect criteria and may aid in the disposition of nonconforming product.
• May work extended hours to complete department goals or tasks, including mandatory overtime.

Qualifications

• Adheres to Standard Operating Procedures and Regulatory requirements.
• Exhibits good communication skills, including verbal, written, and comprehension of the English language.
• Must possess a high level of attention to detail and accuracy.
• Basic coursework in mathematics; must be PC literate, including Microsoft Office Suite.
• Maintains an ongoing understanding of current QA procedures.
• Ability to operate a pallet jack.
• High school diploma or GED required; 2+ years’ experience in Packaging or Distribution and Quality Control or Quality Assurance environments preferred.

Work Environment

Normal Warehouse Conditions: Noisy conditions, hot or humid conditions, exposure to extreme seasonal temperatures, work near moving mechanical parts.

Physical Demands

• Standing - 25-50%
• Sitting - 50-75%
• Walking - 25-50%
• Bending - 75%
• Finger/wrist dexterity - >75%
• Grasping/Pinching - 75%
• Lifting (up to 25 lbs.)

Travel

Not required for this role.