QC Laboratory Specialist

Position Summary:

The QC Laboratory Specialist is responsible for assisting in administration of the quality functions at a site to assure adherence to ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR and other applicable regulatory standards.

This position is responsible for performing quality inspection in accordance with the requirements for ISO, FDA QSR, and STERIS policies. This would include but is not limited to testing raw material, in-process, and finished goods using the various analytical instrumentation (i.e. HPLC, GC) and with supervision perform failure investigation.

What You'll Do:

⦁    Decontaminates, cleans, and sterilizes glassware and other containers. 
⦁    Monitors and maintains laboratory equipment including calibration.
⦁    Prepares media and reagents.
⦁    Performs routine product and raw material testing of samples.
⦁    Performs product and raw material testing of samples.
⦁    Prepares reagents, standard solutions, equipment for use, etc. 
⦁    Recognizes and communicates unexpected results in a timely manner and completes Out of Specification forms (OOS), Non-conformance Reports (NCR) and Incoming Rejection Forms (IRs) for nonconforming or rejected materials.
⦁    Writes and revises standard operating procedures (SOPs) under supervisor’s direction, using Quality software to change, submit and review documents.
⦁    Participates in Investigations (complaints, failure, calibrations, equipment,  etc.).

Experience, Skills, and Abilities:

Required:

• Bachelor's Degree.
• 4 years lab testing experience required with Associate’s degree in a regulated industry (i.e. FDA / ISO13485) accepted in lieu of degree.
• Ability to work in a fast-paced environment with strict deadlines.
• Make recommendations on improvements to test methods and procedures.
• Make decisions on experimental steps and data analysis within defined parameters and guidelines.
• Recognize and communicates unexpected experimental results, Interpret data with direction.

Preferred:

• Bachelor's degree in Chemistry or similar degree.
• Previous experience in chemistry lab.
• Experience using HPLC, FTIR, A.A. Viscometer.
• Strong attention to detail.
• Previous experience working in a manufacturing environment.

Other:

• Ability to lift, push, and pull 10-25lbs.
• Ability to work in a laboratory environment with exposure to chemicals.

What STERIS Offers:

We value our employees and are committed to providing a comprehensive benefits package that supports your health, well-being, and financial future. Here is just a brief overview of what we offer:

⦁    Market Competitive Pay
⦁    Extensive Paid Time Off and (9) added holidays
⦁    Excellent Healthcare, Dental and Vision Benefits
⦁    Long/Short Term disability coverage
⦁    401(k) with company match
⦁    Maternity & Paternal Leave
⦁    Additional add-on benefits/discounts for programs such as Pet Insurance
⦁    Tuition Reimbursement and continued educations programs
⦁    Excellent opportunities for advancement and stable long-term career