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.
This position is day shift Mon-Thurs 5:30am-3:30pm.
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. 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:
• Minimum four (4) years' experience with associate's degree in a regulated industry (i.e. FDA / ISO13485)
• Will accept minimum (4) years relevant lab testing in a regulated industry (i.e. FDA/ISO13485) without associates degree.
Preferred:
• Bachelor's degree with academic lab experience.
We value our employees and are committed to providing a comprehensive benefits package that supports your health, well-being and financial future. Here is 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 a company match
• Maternity and Paternity Leave
• Additional add-on benefits/discounts for programs such as Pet Insurance
• Tuition Reimbursement and continued education programs
• Excellent opportunities for advancement in a stable long-term career
Pay range for this opportunity is $44,000 - $55,000. This position is eligible for bonus participation.
Minimum pay rates offered will comply with county/city minimums, if higher than range listed. Pay rates are based on a number of factors, including but not limited to local labor market costs, years of relevant experience, education, professional certifications, foreign language fluency, etc.
STERIS is an Equal Opportunity Employer. We are committed to equal employment opportunity to ensure that persons are recruited, hired, trained, transferred and promoted in all job groups regardless of race, color, religion, age, disability, national origin, citizenship status, military or veteran status, sex (including pregnancy, childbirth and related medical conditions), sexual orientation, gender identity, genetic information, and any other category protected by federal, state or local law.
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