Scientist I (Metrology)

• Performs, reviews, monitors, tracks laboratory calibrations and preventative maintenance.
• Generates and maintains equipment records from registration through retirement.
• Purchases minor and major equipment and supplies to support laboratory function.
• Develops new Standard Operating Procedures for laboratory testing and equipment administration.
• Maintains SOPs to assure constant compliance with corporate and regulatory requirements.
• Leads new equipment commissioning. Develops protocols for evaluating new equipment and performs validation work. Releases new equipment for use.
• Programs and updates test methods for instrumentation as needed.
• Completes logbook reviews as required.
• Performs equipment troubleshooting.
• Executes equipment and method validation protocols.
• Trains new department personnel in standard operating procedures.
• Investigates nonconforming test results for equipment dispositions, evaluates results to provide conclusions and appropriate action.
• Informs supervisory personnel of all relevant events impacting the operations and performance of the department.
• Maintains knowledge of cGMPs, GLPs and Quality Systems.
• Follows safety requirements and maintains good housekeeping of lab areas.
• Maintains accurate records of all work performed with respect to a given project. Meets facility audit as well as cGMP or GLP requirements.
• Reviews work performed by department staff for accuracy, completeness, and conformance to specifications.
• Coordinates the assembling of supplemental information for regulatory submissions.

Requirements

• B.S. in Chemistry or related field of study.
• 1 year related experience required.
• Background in HPLC and other analytical techniques (IC, UPLC, GC, AA, and ICP-OES/MS) desirable.
• Excellent verbal and written communication skills are essential.

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.

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.