Scientist II

A Scientist II in Quality Control Microbiology displays an advanced knowledge in microbiological test methods,
instrumentation and guides others in routine test methods. A Scientist II participates in the mentoring and training of less
experienced analysts in the group. The QC Microbiology department contains four main functional groups. The principal
activities vary slightly between the groups.

Job Responsibilities:

Understands department priorities and importance of planning ahead.

* Performs peer review of data for accuracy, completeness and conformance to specifications.
* Keeps supervisory personnel informed of all relevant events impacting the operations and performance of the
department including discrepancies and out of limit conditions.
* Be able to articulate work related issues clearly and effectively to management and peers.
* Maintains knowledge of cGMPs and GLPs. Maintains knowledge of current compendial methods.
* Teach or coordinate teaching of training modules and laboratory techniques to new analysts
* Assists in authoring basic investigative studies (OOS, OOT, OOL) and other necessary documents for the Quality Control Microbiology department.

Supports senior personnel in various projects including investigations, special testing and project work.
Investigates deviations from SOP requirements as directed by supervision for potential impact to product and materials and derives root cause of the incident.
* Investigates nonconforming test results including environmental monitoring for product impact, root cause, and evaluates results to provide conclusions and appropriate corrective action.
* Identifies additional testing to be performed to resolve these issues in a timely manner.
* Generates and updates SOPs for microbiology test procedures. Updates and keeps others current.
* Trains new department personnel in related SOPs.
* Ensures safety related polices are adhered and makes recommendations to enhance or improve safety policies.
* Responsible for all aspects of maintenance of equipment and calibrations not performed by metrology or maintenance departments.
* Performs other duties as assigned.

Job Requirements:
* Bachelor of Science degree in a biological science with 3-6 years progressive laboratory experience. Equivalent
combination of education and experience accepted.
* Excellent verbal and written communication skills are essential.
* Planning and organizational skills necessary for primary responsibilities.

Must successfully execute requirements to achieve ISO 5 environment gown certification as required by
supervision.

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.

Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is atwill, 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.