GMP Compliance & Quality Systems Specialist

Fresenius Kabi; Wilson (NC); On-site; USD 95,000 - 120,000; Full time

Benefits offered by this job

401K with company contribution

Medical, dental and vision coverage

Life insurance

Job summary

Fresenius Kabi is seeking a QA Compliance Specialist to collaborate with the Compliance Management Team in identifying and correcting cGMP inadequacies at the Production Unit, and to help develop and implement Quality Systems for audit readiness and regulatory compliance.

The role supports the Annual Product Quality Review (APQR) process and works on regulatory agency requirements, new regulations, and industry standards across six systems. On-site work at the Wilson, NC facility is required.

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.

Job description

Fresenius Kabi is seeking a QA Compliance Specialist to collaborate with the Compliance Management Team in identifying and correcting cGMP inadequacies at the Production Unit, and to help develop and implement Quality Systems for audit readiness and regulatory compliance.

The role supports the Annual Product Quality Review (APQR) process and works on regulatory agency requirements, new regulations, and industry standards across six systems. On-site work at the Wilson, NC facility is required.