GMP Compliance Lead - Audits, CAPA & QMS

Fresenius; Grand Island (NE); Presencial; USD 74 000 - 104 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

401(k) plan with company contributions

Paid vacation

Holiday and personal days

Employee assistance program

Health benefits (medical, prescription

Dental and vision coverage

Resumo da oferta

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.

Qualificações

• 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).

Responsabilidades

• 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.

Conhecimentos

Interpersonal skills

Written communication

Verbal communication

Attention to detail

Problem solving

Formação académica

BA/BS in science

Ferramentas

MS Office (Word, Excel)

Descrição da oferta de emprego

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.