Quality Auditor II - Product Disposition-Quality Systems
Virbac Corporation
Job Description
Experiencing together a unique human adventure
Animal health is key to the health of the planet. Working at Virbac means taking part in a unique human adventure in which the engagement of each individual contributes to its evolution. Encouraging internal mobility between positions and countries, offering individual development plans and building a partnership based on trust between managers and employees are as many perspectives of motivation for our teams. We also offer them a work environment conducive to exploring new territories and balancing their professional and personal lives. Finally, fostering their engagement to animal health also means listening to them and helping them to acquire new skills, preparing them for the challenges of tomorrow and encouraging them to contribute to an ever more responsible approach to our business.
Virbac Animal Health is seeking a Quality Auditor -Product Disposition - Quality Systems for our Quality Assurance team. This position will work within the framework of Virbac's global Quality standards, this position supports the Product Quality Group, continuously improving key systems and processes to ensure product quality, regulatory compliance and efficiency. This position works directly with Production, Planning, CReA Labeling Project Management, Regulatory Affairs, Pharmacovigilance and Canadian counterparts to integrate Quality into the industrial operations. Virbac is an animal health pharmaceutical company that specializes in dental, medicine, and supplements for dogs, cats, and ferrets in the United States.
Qualified candidates must have the following:
A minimum of 4-8 years in a pharmaceutical manufacturing environment in a QA role and related experience.
Total number of years' experience required to fulfill the role: 4-8 years
Experience with Infor M3, Lytho and Global Vision software is preferred
Benefits: 13 Company paid Holidays; 5 personal days (prorated); 15 vacation days (prorated); 5 floating holidays (prorated); 6% 401k match; competitive pay and bonus opportunity; growth opportunities and hybrid schedules based on department and role within the department and much more!
Responsibilities
Area of responsibility 1: [Material Release]
Main activities
Qualified designee performing batch release.
Performs final Quality review and disposition of:
Finished Products
Components
Raw Materials
Third Party Products
Labels
Ensures all criteria for product acceptability are met prior to release.
Perform release in the ERP System (Infor M3)
Reviews Quality Trends to identify opportunities for improvement or potential adverse events as part of the release process
Maintain various Release Trackers to track KPI Release Time
Coordinate activities with multiple departments to meet site and company priorities. Occasional support at the Virbac, Kansas City Distribution Center, as needed
Expected results: Ensures applicable Quality criteria are met for all materials and product released by the Virbac St. Louis site
Area of responsibility 2: [QA Label Master File Management]
Main activities
Maintain the QA Label Master file - managing Active, Pending and Reject labeling through Virbac’s Change Control (CC) process. Prior experience working in a Quality Management System (QMS) is preferred.
Perform timely review and approval of Labeling proofs from various labeling manufacturers against our approved artwork using different softwares (Lytho and Global Vision). Approve artwork if it meets specification and notify labeling manufacturers of your approval.
Ensure all labeling components meet the required Quality levels prior to final release
Regularly interacts with Regulatory Affairs, Project Managers, Labeling Projects Team and other various departments to discuss potential artwork revisions through Change Control (CC)
Coordinates with Third Party QA to notify them of any identified product non-conformances, as required
Coordinates with Regulatory Affairs to review Annual Periodic Drug Experience Reports (DERs)
Coordinate activities with multiple departments to meet site and company priorities. Occasional support at the Virbac, Kansas City Distribution Center, as needed
Expected results: QA Label Master file is maintained accurately and all artwork is managed (processed and approved) in a timely fashion
Area of responsibility 3: [Records Management / Archival]
Main activities
Assist in Batch Record creation, issuance and reconciliation
Assist in the creation, issuance and reconciliation of logbooks
Assist in the tracking and reconciliation of protocols
Assist in physical file management, scanning and indexing in the proper trackers.
Expected results: Assure that the batch records are issued correctly and in a timely manner to meet the production schedule.
Profile
Requirements (Diploma and experience)
A minimum of 4-8 years in a pharmaceutical manufacturing environment in a QA role and related experience
Total number of years' experience required to fulfill the role: 4-8 years
Experience with Infor M3, Lytho and Global Vision software is preferred
Skills
Pharmaceutical QA experience required
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