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. HOURS: Monday through Friday 6am - 2:30pm & overtime as business requires PAY: $22.27 - $27.51hr & bonus. HIRE: Direct, full time. 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.). Required Skills, Abilities, and Experience: Bachelor's degree4 years experience required with an Associate’s degree in a regulated industry (i.e. FDA / ISO13485) in lieu of bachelor's degree.Ability to work in a fast-paced environment with strict deadlinesMake recommendations on improvements to test methods and proceduresMake decisions on experimental steps and data analysis within defined parameters and guidelines.Recognize and communicates unexpected experimental results, Interpret data with direction. Preferred Advanced degree in Biology, Chemistry, or Biochemistry.Experience working in retain room or similar environment.Working experience of ERP systems like Oracle or AS400.Previous experience using LIMS laboratory system.Data review experience preferred. Ability to cross train between chemistry, microbiology, and aseptic labs. Other Lifting, pushing, pulling 10-25lbs.Bending, walking, standing, sitting and typing. Laboratory 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 payExtensive Paid Time Off and added HolidaysExcellent Healthcare, Dental and Vision benefitsLong- and Short-Term Disability coverage401(k) with a company matchMaternity and Paternity LeaveAdditional add- on benefits / discounts for programs such as Pet InsuranceTuition Reimbursement and continuing education programsExcellent opportunities for advancement in a stable long-term career Pay range for this opportunity is $22.27 - $28.82. 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 offers a comprehensive and competitive benefits portfolio. Click here for a complete list of benefits: STERIS Benefits Open until position is filled. STERIS is a leading global provider of products and services that support patient care with an emphasis on infection prevention. WE HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD by providing innovative healthcare and life sciences products and services around the globe. For more information, visit www.steris.com. If you need assistance completing the application process, please call 1 (440) 392.7047. This contact information is for accommodation inquiries only and cannot be used to check application status. 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. We are not only committed to this policy by our status as a federal government contractor, but also we are strongly bound by the principle of equal employment opportunity. The full affirmative action program, absent the data metrics required by 60-741.44(k), shall be available to all employees and applicants for employment for inspection upon request. The program may be obtained at your location’s HR Office during normal business hours.