Finished Goods QA Technician
On-siteConcord, North Carolina, United States
Job Summary
Conduct visual and dimensional inspections of finished medical products against approved specifications, verifying labeling, packaging, and lot traceability while documenting results accurately. Perform sampling activities per established plans and support finished goods release by reviewing batch records, Device History Records, and testing data for compliance. Maintain inspection logs and electronic quality systems in accordance with Good Documentation Practices, escalating discrepancies to leadership. Ensure audit readiness by adhering to FDA regulations, cGMP requirements, and data integrity standards while participating in root cause investigations. Work extended shifts standing or walking up to eight hours, lifting up to 25 lbs, in a manufacturing environment with occasional overtime based on production demands.
Required Qualifications
- Minimum High School / GED or equivalent
- Minimum of 2 years of experience in Quality, Manufacturing, Inspection, or a regulated production environment
- Experience performing inspections and reviewing manufacturing documentation
- Basic computer skills and proficiency with Microsoft Office applications
- Knowledge of cGMP requirements and regulatory standards
- Understanding of SOPs, Work Instructions, and quality systems
- Strong attention to detail and documentation accuracy
- Ability to identify and escalate quality issues effectively
- Must be able to stand and/or walk for extended periods (typically up to 6–8 hours per shift)
- Ability to visually inspect finished products for extended durations
- Ability to lift, carry, push, or pull materials or product samples, typically up to 25 lbs
- Must be able to wear required personal protective equipment (PPE)
- Ability to perform tasks that require fine motor skills, such as labeling verification, measurement checks, and handling of inspection tools
- Ability to work in a manufacturing or warehouse environment with exposure to noise, moving equipment, and varying temperatures
- Occasionally required to work overtime or adjust schedule based on production and release demands
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