Compliance Officer

Fresenius Kabi•Grand Island, NY

11d

About The Position

The Compliance Officer works with the Compliance Management Team to administer and maintain the Quality Systems at the Production Unit from FDA and global perspectives. The role leads teams and projects to identify and correct cGMP inadequacies and maintain a high level of compliance and Regulatory Audit readiness. The incumbent provides expertise in deviation investigations, complaints, and Annual Product Review, helps maintain the compliance of the CAPA system, and reviews and approves documentation for regulatory correspondence.

Requirements

BA/BS degree in a science field, such as Biology, Microbiology, Chemistry, Engineering, or Pharmacy.
3–5 years of pharmaceutical or related work experience, with emphasis on current Good Manufacturing Practices.
Working knowledge of GMP, EU, and GLP, as well as FDA trends and guidelines.
Demonstrated problem-solving and troubleshooting experience.
High degree of attention to detail.
Strong interpersonal, written, and verbal communication skills.
Ability to interface positively with Regulatory Agencies, vendors, and company departments.
Good knowledge of MS Office programs, including Word and Excel.

Responsibilities

Serve as the compliance subject matter expert for internal audits and support external and Regulatory Authority audits.
Coordinate collection of information for Regulatory Requests and assist with compliance to commitments made to Regulatory Authorities.
Complete Complaint and Event Investigations, including risk assessment, product and field safety impact assessment, facilitating subject matter expert discussions, gathering and analyzing relevant data, root cause analysis, and corrective/preventive action determination.
Lead internal audit teams to inspect and remediate system and process noncompliance in the plant.
Maintain the Site Master File.
Support compilation of Annual Product Quality Reviews.
Ensure deadlines are maintained for all project types and extensions are properly justified and documented to maintain compliance.
Maintain site information for global databases.
Perform other tasks as directed or requested by management or site leadership.
Ensure compliance with company documents, programs, and activities related to Health, Safety, Environment, Energy, and Quality Management Systems, in accordance with assigned roles and responsibilities.