QA Release Technician - 1st

Role Summary

QA Release Technician - 1st shift. Responsible for response to quality events, containment and remediation, and auditing of manufacturing and packaging processes to ensure compliance with cGMP.

Responsibilities

• Respond to quality events and complete related documentation.
• Determine immediate physical containment and remediation for defects.
• Identify, assess, and contain defects; conduct ASPs and manage the rework process including providing rework instructions.
• Review documentation as necessary.
• Audit Perrigo manufacturing and packaging processes to ensure compliance with applicable cGMP requirements.

Qualifications

• Required: High school diploma or GED; 6 months of experience in an FDA regulated environment; understanding of cGMPs; working knowledge of SOPs; ability to provide clear direction and interpretation.
• Preferred: 2 years of experience in an FDA regulated industry; advanced education (2-year or 4-year degree, or progress toward a degree); strong analytical skills; excellent oral and written communication; ability to work independently under multiple deadlines; understanding of equipment operation and manufacturing/packaging processes.

Skills

• Analytical thinking
• Effective communication (oral and written)
• Interpersonal skills
• Ability to work independently under deadlines

Education

• High school diploma or GED required; advanced education preferred.

Additional Requirements

• 1st shift position; additional hours may be required based on organizational needs.