QA Auditor I

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 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 walkthroughs 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 SOPsApprove 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, 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
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