QA Auditor I

About the role

The Quality Assurance In-Process (QAIP) Auditor I supports Manufacturing, Packaging, R & D, Technical Operations, Engineering, and QC operations by performing room and equipment line clearance, visual inspection of finished products, collecting stability and retain samples, conducting in-process audits, and reviewing batch records in real time. Additionally, QAIP auditors conduct daily walkthroughs to ensure the facility remains audit-ready.

Responsibilities

• Ensure GMP compliance throughout the facility.
• Enforce cGMP regulations and Aveva’s Standard Operating Procedures (SOPs).
• Maintain knowledge of Production Manufacturing and Packaging SOPs.
• Approve shipper labels, roll labels, and clinical labels.
• Perform room and equipment line clearance for the packaging process.
• Conduct in-process audits of manufacturing and packaging areas, including on-line batch record reviews for compliance.
• Prepare and execute AQL plans.
• Complete QA Envelope Documentation (Room Release, Start-up, and executed AQL plans).
• Evaluate and impound substandard materials.
• Sample products for on-line inspection, AQLs, stability, reworks, controlled substances, etc.
• Monitor in-process product defects, including tracking, trending, and assessment.
• Prepare product defect samples for the Defect Library.
• Conduct surface swab sampling and release based on swab test results.
• Support Annual Product Review (APR) and coordinate QA Reserve Sampling Room activities.
• Execute QAIP walkthroughs to ensure facility readiness.
• Comply with Aveva’s facility and department SOPs and approved batch records.
• Collaborate with Production Supervisors/Section Leaders to resolve product quality issues.
• Identify quality concerns and escalate to management as appropriate.
• Initiate investigations as required.
• Work as a team member to achieve outcomes.
• Operate in accordance with Aveva’s Code of Conduct, Business Ethics, and all regulatory, compliance, and safety requirements.
• Perform additional duties as assigned by QA Management.

Requirements

• High School Diploma or equivalent, and/or two years of college.
• Two to four years of related experience and/or training, or an equivalent combination of education and experience.
• Experience working with cGMP procedures in a pharmaceutical and/or combination device manufacturing facility.

Skills

• Excellent written and verbal English communication skills.
• Proficiency with Microsoft Office products (Word, Excel, Access, PowerPoint).
• Experience with JD Edwards ERP system is an asset.
• Superior interpersonal skills and ability to work effectively in a team environment.
• Ability to manage multiple priorities in a fast-paced environment.
• Strong attention to detail.