Job Summary

Oversees the implementation of quality plans and assurance regulations, revises SOPs, supports audits and inspections, and leads the adoption of new regulations to ensure GCP standards are met in clinical trial processes.

Responsibilities

Responsibilities (including, but not limited to):

• Be able to articulate work related issues clearly and effectively to management and peers

• Performs accurate routine testing utilizing instrumental methods of analysis (HPLC, TLC, FTIR, pH, UV-Vis) with emphasis on chromatography to meet departmental objectives.

• Updates and routes SOPs, MOAs, Specifications through Documentum as delegated by supervisor.

• Performs troubleshooting of instrumentation by applying problem solving skills.

• Provides guidance to Associate Scientist personnel when necessary.

• Documents testing in compliance with Good Documentation Practices

• Manages work and time based on departmental priorities using own judgement and objective reasoning.

• Performs peer review of data to ensure compliance and accuracy.

Requirements:

• Possess a B.S. in Chemistry, Biology or related physical science.

• 1-4 years of related experience in pharmaceutical industry and a familiarity with cGMP and FDA regulations.

• Must have hands-on experience and knowledge of chromatographic methods and related chromatography data systems (i.e. Empower).

• Must be proficient in Microsoft Office (Word, Excel). 

• Must be flexible with continually changing projects and priorities.

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, 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.

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.