QA Auditor I

DescriptionThe 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, Manufacturing In-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 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

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