QC Laboratory Specialist

The QC Laboratory Specialist is in our Mentor, OH location 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 QC Laboratory Specialist 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, FTIR and/or UV Spectrophotometers) and with supervision to perform failure investigation.

This position requires working onsite in our Mentor, OH location. The hours for this role are Monday through Thursday 6:00 am to 3:30pm and Fridays 6:00 am to 10:00 am.

• 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.).

Required:

• Bachelor's degree in biology, chemistry or related technical field.
• In lieu of a Bachelor's degree, an Associates' degree in biology, chemistry or related technical field, and a minimum of four years' experience in a laboratory environment is required, preferably in a regulated industry (i.e. FDA / ISO13485).

Other:

• 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.

We value our employees and are committed to providing a comprehensive benefits package that supports your health, wellbeing, and financial future.

Here is just a brief overview of what we offer:

• Market Competitive pay
• Extensive Paid Time Off and added Holidays
• Excellent Healthcare, Dental and Vision benefits
• Long- and Short-Term Disability coverage
• 401(k) with a company match
• Maternity and Paternity Leave
• Additional add- on benefits / discounts for programs such as Pet Insurance
• Tuition Reimbursement and continuing education programs
• Excellent opportunities for advancement in a stable long-term career

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