Job SummaryThe Compliance Officer works with the Compliance Management Team to administer and maintain the Quality Systems in place at the Production Unit from a FDA and global perspective. This function leads teams and projects to identify and correct cGMP inadequacies and ensure a high-level of compliance and Regulatory Audit readiness. The incumbent provides expertise in Deviation investigations, Complaints, Annual Product Review, and helps maintain the compliance of the CAPA system, as well as, reviewing and approving necessary documentation for regulatory correspondence.
Salary Range: $73,614-$103,528 + 6% annual bonus
Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.
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.
Requirements- 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
Additional InformationWe 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.
