Responsible for executing the various quality systems and business practices which enable positive outcomes of Health Authority (HA) inspections, as well as other external and internal audits. Responsible for the ownership and/or execution of the various processes and systems related to the Quality Compliance function at the Covington Manufacturing Facility including, but not limited to: inspection readiness, inspection management, product complaint management, risk management, and quality incident escalations. The role will entail identifying and implementing continuous improvement initiatives related to the site’s Quality Systems.
This position will serve as either a ready room coordinator, inspection liaison, and/or inspection host during inspections. The role will include being an independent internal auditor to perform site self inspections. This position is also responsible for leading various projects internal and/or external to the department. The level is also responsible for collaborating within the network to share inspection knowledge and drive process improvements at the site and global level. This level is expected to demonstrate skills as a subject matter expert during internal and external inspections.
Responsible for maintaining the site compliance program including GMP/Compliance walkthroughs, gap assessments, and delivery of continued education on GMP and Compliance; the handling of product complaints including timely closure of associated records; and the preparation and maintenance of key quality indicators and site metrics for the appropriate communication to Site Leadership and Global teams.
Supervision and guidance are mainly required to clarify directions; this level is capable of determining their own priorities and working with area and senior management to eliminate roadblocks.
Job Function and Description
This job posting excludes CO applicants.
USA – GA – Social Circle – Hwy 278
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