QA Auditor I

About Us:
Aveva Drug Delivery Systems is a pharmaceutical manufacturer at the forefront of innovative drug delivery technologies. We are dedicated to advancing solutions that optimize the efficacy, safety, and precision of pharmaceutical treatments. Join our team and help shape the future of healthcare by contributing to the development of groundbreaking drug delivery systems that improve patient outcomes worldwide.

Job Summary:

The Quality Assurance In-Process (QAIP) Auditor I is responsible for the day-to-day support to the 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 from the production line, conducting Packaging, Manufacturing In-process audits to ensure that the Intermediate materials and packaged products conform to the established quality standards and conducting on-line batch record review in real time. In addition, the QAIP auditors are responsible for daily walkthroughs ensuring that the facility is Audit ready at all times.

Key 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
• Room and equipment line clearance for the packaging process
• In-process audit of all areas of manufacturing and packaging; on-line reviewing batch documentation for compliance to batch record requirements and product specifications.
• Preparation and execution of AQL plans
• Completion of the QA Envelope Documentation (Room Release, Start up, and executed AQL plans)
• Perform Evaluation / impound of Substandard Materials
• Sampling products for on-line inspection, AQLs, stability, Reworks, Controlled Substance, etc.
• Monitor the In-Process product defects Tracking, Trending Assessment
• Monitor the Preparation of the Product Defect Samples for the Defect Library
• Conduct surface swab sampling and swab release based on swab test results
• Support Annual Product Inspection (APR) and Coordination of the QA Reserve Sampling Room
• Execution of QAIP walkthroughs
• Comply with and ensure that all activities are performed according to Aveva’s facility and Department core SOPs and approved batch records.
• Collaborate with Production Supervisor/Section Leader to resolve product quality issues.
• Identifies quality concerns and escalates to management as appropriate
• Initiation of Investigation as required.
• Works as a member of a team to achieve all outcomes.
• Operates in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements.
• Performs all work in support of company Values: Innovate, Evolve, and Excel
• Other duties assigned as assigned by the QA Management

Education:

• High School Diploma or equivalent.
• Two years of college preferred.
• Two to four years of related experience and/or training. Relevant experience working in a pharmaceutical manufacturing or similar industry, experience.
• Equivalent combination of education and experience will be considered.

Knowledge, Skills, and Abilities:

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

Benefits

Aveva Drug Delivery Systems and DifGen Pharmaceuticals offer a comprehensive benefits plan, including:

• Medical, Dental, and Vision Insurance
• Paid Time Off
• 401k with employer match
• Paid Holidays and Floating Holiday

Equal Opportunity Employer