Compliance Officer

Fresenius Kabi; Grand Island (NE); On-site; USD 74,000 - 104,000; Full time

Benefits offered by this job

401(k) plan with company contributions

Paid vacation

Holiday and personal days

Employee assistance program

Health benefits (medical, prescription

Dental and vision coverage

Job summary

Fresenius Kabi in the United States is seeking a Compliance Officer to partner with the Compliance Management Team. You will administer and maintain Quality Systems at the Production Unit from a FDA and global perspective, lead teams on cGMP improvements, and ensure regulatory audit readiness and CAPA documentation.

The role involves deviations, complaints, annual product reviews, and liaising with regulatory authorities; a BA/BS in science and 3–5 years in pharma with GMP exposure are expected.

Qualifications

• BA/BS degree in science field (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 problem solving / trouble shooting experience.
• Strong attention to detail and ability to interface with Regulatory Agencies, vendors and internal teams.
• Proficient with MS Office programs (Word and Excel).

Responsibilities

• Serves as the compliance SME for internal audits and supports regulatory audits.
• Coordinates information for Regulatory Requests and maintains commitments with authorities.
• Completes deviation investigations, root cause analysis, and CAPA determinations.
• Leads internal audit teams to remediate noncompliance in the plant.
• Maintains the Site Master File and supports Annual Product Quality Reviews.
• Ensures deadlines for all projects are met and properly documented.
• Maintains site information for global regulatory databases.

Skills

Interpersonal skills

Written communication

Verbal communication

Attention to detail

Problem solving

Education

BA/BS in science

Tools

MS Office (Word, Excel)

Job description

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 andvision 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 permanentemployment arrangement. All employment is at‑will, meaning both the employeeand 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 applicantswill receive consideration for employment without regard to race, color, religion, sex, national origin,citizenship, immigration status, disabilities, and protected veteran status.