Compliance Officer

Fresenius Kabi USA, LLC seeks a Compliance Officer to administer and maintain production-unit quality systems from FDA and global perspectives. The role leads compliance projects and audits, investigates complaints and events, supports regulatory requests and product quality reviews, and maintains compliance documentation and systems.

Responsibilities

• Serves as the compliance SME for all internal audits and supports external and Regulatory Authority audits
• Coordinates the collection of information for all Regulatory Requests and assists in the compliance to commitments made to all Regulatory Authorities
• Completes Complaint and Event Investigations, including performing risk assessment, impact to product in the field and field safety, facilitating SME discussions, gathering an analyzing relevant data, performing root cause analysis and CA/PA determination
• Leads internal audit teams to inspect and remediate system and process noncompliance in the plant
• Responsible for the Site Master File
• Supports compilation of Annual Product Quality Reviews
• Ensures that deadlines are maintained for all project types and that extensions are properly justified and documented to maintain compliance
• Maintaining site information for global databases
• Any other task as directed or requested by management or site leadership
• All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities

Benefits

• 6% Annual Target Bonus
• 401(k) plan with company contributions
• Paid vacation, holiday and personal days
• Employee assistance program
• Health benefits including medical, prescription drug, dental and vision coverage
• Life insurance
• Disability
• Wellness program

Company

• Healthcare products and therapies for critically and chronically ill patients
• Lake Zurich, Illinois, USA
• http://www.fresenius-kabi.us/
• Founded in 1996
• 1001-5000 employees

Qualifications

• BA/BS Degree in science field, e.g., Biology, Microbiology, Chemistry, Engineering, Pharmacy, etc
• 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 experience in problem solving/trouble shooting
• High degree of attention to detail
• Candidate must possess strong interpersonal, written, and verbal communication skills
• Incumbent must be able to interface positively with Regulatory Agencies, vendors, and company departments
• Good knowledge of MS Office programs, including Word and Excel

Required skills

• Current Good Manufacturing Practices (cGMP), FDA Regulations, Laboratory Practice (GLP), Microsoft Office

Experience

• 3-5 years