Microbiologist (Micro) I, II, & III

Essential Duties & Responsibilities

Coordinates microbiological testing, release of product, and testing for validation protocols.
Performs organism identification.
Performs technical review of batch filling records to ensure quality of aseptic processes.
Reads and interprets microbiological cultures and other related tests, including but not limited to environmental monitoring, sterility tests, growth promotion, and microbial limits tests.
May perform validation, technology transfer, and troubleshooting, and write policy procedures for quality initiatives.
Reviews and approves environmental monitoring data, laboratory equipment, and records. Prepares process and status reports, assigns and monitors document numbers, and reviews documents for accuracy and completeness.
Performs other functions as required or assigned
Complies with all company policies and standards
Requirements

Essential Duties & Responsibilities

Coordinates microbiological testing, release of product, and testing for validation protocols.
Performs organism identification.
Performs technical review of batch filling records to ensure quality of aseptic processes.
Reads and interprets microbiological cultures and other related tests, including but not limited to environmental monitoring, sterility tests, growth promotion, and microbial limits tests.
May perform validation, technology transfer, and troubleshooting, and write policy procedures for quality initiatives.
Reviews and approves environmental monitoring data, laboratory equipment, and records. Prepares process and status reports, assigns and monitors document numbers, and reviews documents for accuracy and completeness.
Performs other functions as required or assigned
Complies with all company policies and standards
Position Requirements and Qualifications

Minimum Qualifications:

Education:

A 4-year Bachelor’s degree, preferably in a science or engineering discipline
Experience:

Previous experience for Micro I (0 to 2 years or more), Micro II (2 to 5 years or more), and Micro III (5 plus years) in a cGMP biologics/biosimilars manufacturing laboratory environment is required.
Working knowledge of cGMP regulations (21 CFR210/211/820) is desired.
Working knowledge of Deviation, CAPA, Change Control, and Validation/Qualification (IQ/OQ/PQ) is desired.
Certification from professional organizations such as ASQ and ISPE is desired but not required.
Preferred Qualifications:

SPECIALIZED KNOWLEDGE AND SKILLS:

Other special projects and/or duties may be assigned by Management.
Trains other Microbiologists on Department methods, processes, and procedures.
Works with other departments to accomplish Company goals or projects.
Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.
Ability to write routine reports and/or correspondence.
Ability to speak effectively before groups or employees of the organization.
Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.