Cleanroom Lab Analyst - Sterility Assurance (Early Day Shift)

Job Description

Product Sterility Laboratory Analyst I

Classification:

Non - Exempt

Schedule:

Traditional

Job summary:

The Product Sterility 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 Product Sterility 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.The name Sotera Health was inspired by Soteria, the Greek goddess of safety, a...