Compliance Specialist

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

Job Summary

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.

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

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program.

Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is at‑will, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

Fresenius Kabi is a global health care company that specializes in injectable medicines, biosimilars, and technologies for infusion, transfusion, and clinical nutrition.

Our expansive portfolio of products and global network of science and manufacturing centers provide essential support for the care of critical and chronically ill patients. With more than 41,000 employees worldwide, our dedicated team is united by our shared purpose: to put lifesaving medicines and technologies in the hands of people who care for patients – and to find answers to the challenges they face. We call this purpose caring for life.

Our U.S. headquarters is in Lake Zurich, Illinois and the company’s global headquarters is in Bad Homburg, Germany.

Follow us on LinkedIn to learn more: http://bit.ly/3KdaGJr