Qa associate iii - united states, athens

The purpose of this position is review and approval of batch records, government release documentation and release of starting materials, in process and finished biological product.  this position assures that all specifications are met prior to each stage of release to comply with usda and cgmp regulatory requirements relating to these areas.  the scope of support includes every stage of manufacturing, including product received from 3rd party contract manufacturing organizations (cmos).  this individual will be a resource for related technical and compliance information within the quality and compliance unit.
documentation review/approvals: review batch record documentation for compliance to good documentation practices, outline of production, special outline and against established sops/standards. collaborate with production teams to improve the overall quality of completed documentation through training, coaching, document creation/revisions in idea for con, etc. actively participate in assigned value stream meetings.change control: performs review and approvals of change controls as a subject matter expert (sme)in qa release for routine change controls. completes change control action items as assigned. revises existing procedures as changes occur.deviations/capa: initiates deviations in quality electronic systems when non-conformances are detected during documentation review. writes or participates in deviation investigations for determination of appropriate root causes. performs follow-up on capas for completion. oracle: performs oracle release activity for intermediates and finished product which includes manufacturing date entry, expiry date validity check, and status changes.oracle: performs oracle release activity for intermediates and finished product which includes manufacturing date entry, expiry date validity check, and status changes.inspection: performs review/release approval of serials/lots. routinely reviews specifications/ standards/ inspection plans for compliance to current regulatory requirements. on the floor inspections are done on a routine basis to provide a qa presence.audits/inspections: participates in internal audits as assigned by management. serves as an sme for strategy rooms during internal and external audits/inspections. audit preparation for regulatory agency audits/customer inspections and participation through demonstration of job tasks during inspections may be required as needed.skills: exceptional logical skills with excellence in written and verbal communication skills. excellence in comprehension/application of usda and eu regulatory requirements for production and distribution of regulated biological articles. strong theoretical and practical knowledge of regulated processes and one technical discipline, such as biology to apply knowledge or experience to assigned tasks. ability to make decisions with some supervision regarding the acceptability of product based on documentation provided.

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