Cleanroom Lab Analyst - Sterility Assurance (Early Day Shift) (Finance)

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, and reflects the Company's unwavering commitment to its mission, Safeguarding Global Health®. Sotera Health Company is a leading global provider of mission-critical sterilization and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry recognized scientific and technological expertise, we help to ensure the safety of millions of patients and healthcare practitioners around the world every year. Across our 64 facilities worldwide, we have over 3,000 employees who are dedicated to safety and quality. We are a trusted partner to more than 5,800 customers in over 50 countries, including more than 40 of the top 50 medical device companies and 8 of the top 10 global pharmaceutical companies.

Sotera Health goes to market through its three best-in-class businesses - Sterigenics®, Nordion® and Nelson Labs®. Sterigenics is a leading global provider of outsourced terminal sterilization and irradiation services for the medical device, pharmaceutical, food safety and advanced applications markets. Nordion is the leading global provider of Co-60 and gamma irradiators, which are key components to the gamma sterilization process. Nelson Labs is a global leader in outsourced microbiological and analytical chemistry testing and advisory services for the medical device and pharmaceutical industries. Learn more about Sotera Health at soterahealth.com.