The Sterility Assurance Laboratory Analyst conducts GLP and non-GLP studies following established approved procedures and under the supervision of the Study Director or Department Manager. Additionally, the Sterility Assurance Laboratory Analyst performs their work in a cleanroom, isolator or walk-in incubator environment, records data concurrently, maintains traceability of samples throughout testing and notifies the Study Director of any unforeseen circumstances or events that occur during testing.

Essential job functions:

Scientific/General

• Perform product sterility studies, both GLP and non GLP; start to finish under supervision of the Study Director.
• Order supplies and media.
• Ensure testing is conducted according to approved procedures (SOP, STP, PDS, SDS, etc)
• Initiate/document quality events (e.g., unexpected results, amendments, deviations, etc.)
• Assist with protocol amendments.

Regulatory & Compliance

• Know and follow applicable regulatory requirements (GMP, GLP, ISO, etc).

• Know and follow company policies and procedures.
• Ensure all data are accurately and concurrently recorded.
• Notify the Study Director of any unforeseen circumstances or events that occur during testing.

Professional Development

• Complete training prior to performing procedures.
• Complete required training in a timely manner.

Customer Service

• Uphold the NLI service standard.

• Meet or exceed sponsor expectations.

Perform other duties as assigned

Job requirements:

• Extreme attention to detail
• Ability to follow sequential written instructions
• Must have verbal and written communication skills
• Project management skills
• Delegation and follow-up skills
• Math skills required- computing percentages, averages, surface area, etc.
• Must be able to multi-task and be self-motivated
• Computer Skills: knowledge of Microsoft Office
• Time management- must be able to respond to voicemails, emails and other communications in a timely manner
• Ability to work independently
• Technical knowledge, especially microbiology
• Lab equipment skills

Physical requirements:

Employee must stand and walk for 80% of the day; sit at a desk for 20%, 15% of sitting time is spent working on the computer. Employee must be able to lift a minimum of 25 lbs. Employee must be able to perform duties while wearing cleanroom garments and/or when exposed to 35 degree C heat.

Education and experience requirements:

A.A. /A.S. OR High School Diploma and One Year Applicable Experience OR B.S. degree (Microbiology or biological science strongly preferred). Completion of Product Sterility training and qualifications with passing scores where applicable.