Line QA

Job Summary
We are seeking a detail-oriented QA Line Reviewer and responsible for performing on-floor quality assurance oversight during manufacturing and packaging operations. This role ensures compliance with GMP, SOPs, batch record requirements, and regulatory expectations. The Line Reviewer acts as a real-time quality gatekeeper, identifying deviations, preventing product mix-ups, and supporting the release of high-quality products.

Responsibilities

• Perform on-floor QA oversight during manufacturing and packaging operations to ensure GMP compliance.
• Conduct line clearances, verify components, and prevent mix-ups during changeovers.
• Review batch records and in-process documentation for accuracy, completeness, and data integrity.
• Perform batch record reconciliation, including material, component, label, and yield verification.
• Identify and escalate deviations, discrepancies, and non-conformances in real time.
• Support investigations, CAPAs, and root cause analysis related to line activities.
• Ensure proper equipment status, cleaning verification, and adherence to SOPs.
• Provide GMP guidance and coaching to operations personnel as needed.
• Assist during audits and inspections by presenting accurate and compliant documentation.

Qualifications

• Experience
• 1-2 years in a GMP pharmaceutical or regulated manufacturing environment.

Skills & Competencies

• Strong attention to detail and ability to identify discrepancies.
• Solid understanding of GMP, FDA regulations, and data integrity principles.
• Effective communication skills and ability to work collaboratively with operations.
• Ability to work in a fast-paced environment with shifting priorities.
• Experience in batch record review or QA on-the-floor oversight preferred.

Pay: $ $18.00 per hour

Expected hours: 40.0 per week

Benefits:

• Paid time off

Work Location: In person