QA Auditor I

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

Job Responsibilities:

• Ensure GMP compliance throughout the facility
• Enforce cGMP regulations and Aveva’s Standard Operating Procedures (SOPs)
• Maintain knowledge of Production Manufacturingand PackagingSOPs
• Approve Shipper labels/roll labels, and clinical labels
• Room and equipment line clearancefor the packaging process
• In-process auditof all areas of manufacturing and packaging; on-line reviewing batch documentation for compliance to batch record requirements and product specifications.
• Preparation and execution ofAQL 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

Qualifications

• Education
  • High School Diploma or equivalent, and or two-years of college; and two-four years related experience and/or training; or equivalent combination of education and experience.

knowledge, Skills and Abilities

• Excellent written and verbal English communication skills.
•  Experience with Microsoft Computer Products (Words, excel, Access, PowerPoint). Experience in JD Edwards ERP system is an asset
• Superior interpersonal skills and ability to work effectively in a team environment within and outside the department
• Ability to manage multiple priorities in a fast-paced environment
• Attention to detail

Experience

• Experience Working with cGMP procedures in a Pharmaceutical and or Combination Device manufacturing facility