Compliance Specialist

Fresenius Kabi USA•Wilson, NC

13d

About The Position

The QA Compliance Specialist works with the Compliance Management Team to identify and correct cGMP inadequacies at the Production Unit, as well as, helping to develop and implement Quality Systems designed to maintain a high level of internal and external audit readiness and Regulatory Compliance. The position is responsible for facilitating the approval of the Annual Product Quality Review (APQR) and the development of relevant systems designed to maintain compliance with the various APQR procedures and Regulatory Agency requirements. The QA Compliance Specialist participates in compliance initiatives based on new regulations, guidance documents and industry standards and applies them to the six systems when directed. The position will also provide support for event initiation, investigations, and internal audits.

Requirements

cGMP inadequacies identification and correction
Development and implementation of Quality Systems
Facilitating Annual Product Quality Review (APQR) approval
Applying new regulations, guidance documents, and industry standards to six systems
Support for event initiation, investigations, and internal audits
Adherence to regulatory requirements and industry guidance
Compliance of document storage and archiving
Coordination of compliance initiatives
Participation in FDA readiness audits

Responsibilities

Participates in multi-functional project teams as a Compliance representative as directed by the Compliance Management Team
Responsible for compiling, processing and facilitating the Annual Product Quality Review in a timely manner
Assists in ensuring adherence to regulatory requirements and industry guidance through the review of appropriate documentation and internal audit activities as directed by the Compliance Management team
Responsible for the compliance of the storage and archiving of documents with company policy and Regulatory Agency requirements
Assists and coordinates compliance initiatives based on new regulations, guidance documents and industry standards as they apply to site Quality Assurance
Participate in FDA readiness audits as required by the Compliance Management team
Performs other duties as assigned by Compliance Supervisor, Manager, or Director of Quality Assurance