Scientist I

Job Summary

A Scientist I in Quality Control Microbiology is responsible for an intermediate level of expertise of microbiological test methods, and instrumentation. A Scientist I participate in the mentoring and training of less experienced analysts in the group. The QC Microbiology department contains five main functional groups. The principal activities vary slightly between the groups.

Responsibilities

All Scientist I groups are responsible for the following:

• All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and 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, invalid tests) and other necessary documents for the Quality Control Microbiology department (Not applicable for ID Lab; except invalid runs).

• 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.

• Updates SOPs or Methods of Analysis for microbiology test procedures to remain current.

• 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.

• Maintains current training compliance through Kabilift.

• All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities.

Finished Products Testing

• Schedules, initiates, coordinates, performs routine testing of in-process, finished product, raw material, and components. Scientist I may know most but not all procedures used.

• Conduct environmental monitoring during bioburden testing and sterility testing (SKAN isolators).

• Assists with activities required for microbial identification including sub-culture, Gram staining, proper culture maintenance and processing for outside laboratory identification.

• Maintains testing equipment and coordinates requalification, preventative maintenance and calibration as needed.

• Processes paperwork, LIMS input and approvals for release by QA.

• Provides data for annual product reviews, investigational requests and validation studies.

REQUIREMENTS

• Bachelor of Science degree in a biological science with 1-3 years progressive laboratory experience.

• For positions in the Maldi ID Laboratory, previous experience on microbial identification using this system is desirable.

• Excellent verbal and written communication skills are essential.

• Planning and organizational skills necessary for primary responsibilities.

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 match, and wellness 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.