Quality Compliance Specialist - Regulatory Audits

301044 Fresenius Kabi USA, LLC; Kansas; On-site; USD 70,000 - 105,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

Disability insurance

401K with company contribution

Wellness program

Job summary

Fresenius Kabi USA, LLC is seeking a QA Compliance Specialist to work with the Compliance Management Team to identify and correct cGMP inadequacies at the Production Unit and to help develop and implement Quality Systems for audit readiness and regulatory compliance.

The role includes facilitating the Annual Product Quality Review (APQR), supporting event initiation, investigations, and internal audits, and contributing to regulatory guidance alignment across six quality systems.

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 USA, LLC is seeking a QA Compliance Specialist to work with the Compliance Management Team to identify and correct cGMP inadequacies at the Production Unit and to help develop and implement Quality Systems for audit readiness and regulatory compliance.

The role includes facilitating the Annual Product Quality Review (APQR), supporting event initiation, investigations, and internal audits, and contributing to regulatory guidance alignment across six quality systems.