Fresenius Kabi

Fresenius Kabi

Compliance Officer

Grand Island, NY

Sponsorship not specified$74k-$104kDetected 26 days ago
ExcelAuditingGMPFDA RegulatoryCommunicationProblem SolvingMicrosoft OfficeInternal Audit

About the role

  • 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.

Responsibilities

  • Serves as the compliance SME for all internal audits and supports external and Regulatory Authority audits
  • Leads internal audit teams to inspect and remediate system and process noncompliance in the plant.
  • Ensures that deadlines are maintained for all project types and that extensions are properly justified and documented to maintain compliance.

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
  • High degree of attention to detail
  • Incumbent must be able to interface positively with Regulatory Agencies, vendors, and company departments.

Compensation

  • $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.
  • 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.

Benefits

  • We 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.

Equal opportunity

  • 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.

Visa & Work Authorization

  • ied applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status
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This listing is sourced directly from Fresenius Kabi's careers page and normalized into a canonical job model.