Compliance Officer

Fresenius Kabi USA, LLC; Town of Grand Island (NY); Sur place; USD 74 000 - 104 000; Plein temps

Avantages offerts par ce poste

401(k) plan with company contributions

Health benefits: medical, dental, and视

Paid vacation, holidays and personal/„

Résumé du poste

Fresenius Kabi USA, LLC is seeking a Compliance Officer to lead quality systems from a FDA and global perspective. The role works with the Compliance Management Team to identify and correct cGMP inadequacies and ensures audit readiness.

Responsibilities include deviation investigations, complaints, annual product reviews, and CAPA documentation. Salary range is $73,614 to $103,528 annually plus a 6% annual target bonus.

Qualifications

• BA/BS degree in science field (e.g., Biology, Microbiology, Chemistry, Engineering, Pharmacy).
• 3-5 years pharmaceutical or related experience with emphasis on current Good Manufacturing Practices (cGMP).
• 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.
• Strong interpersonal, written, and verbal communication skills.
• Incumbent must interface positively with Regulatory Agencies, vendors, and company departments.
• Proficiency with MS Office programs, including Word and Excel.

Responsabilités

• Serves as the compliance SME for all internal audits and supports external and Regulatory Authority audits.
• Coordinates the collection of information for Regulatory Requests and assists in compliance to commitments with Regulatory Authorities.
• Completes Complaint and Event Investigations, including risk assessment, data gathering and root cause analysis.
• Leads internal audit teams to inspect and remediate system and process noncompliance in the plant.
• Responsible for the Site Master File and supports Annual Product Quality Reviews.
• Ensures deadlines are maintained for all project types and extensions are justified and documented.
• Maintains site information for global databases.
• Supports other tasks as directed by management or site leadership.
• All employees ensure compliance with Health, Safety, Environment, Energy, and Quality Management Systems.

Connaissances

Problem solving

Attention to detail

Interpersonal skills

Verbal communication

Written communication

MS Office

MS Word

MS Excel

Formation

BS in science

Outils

MS Office

Word

Excel

Description du poste

Job Summary

The 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 Annually + 6% Annual Target Bonus

Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.

Our benefits programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage.

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 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, andwellness program.

Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is atwill, 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.