Senior QC Laboratory Specialist

<div><div style='padding: 10px 0px;border: 1px solid transparent;'><div style='font-size:16px;word-wrap: break-word;'><H2 style='font-size: 1em; margin: 0px'><b>Position Summary:</b></H2></div><div><p><span style="font-family: arial, helvetica, sans-serif;">The Senior 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.</span></p><p><span style="font-family: arial, helvetica, sans-serif;">This role is responsible for generating test methods, reports, and specifications for raw material, in-process, and finished goods in accordance with the requirements for ISO, FDA QSR, and STERIS policies. This would include but is not limited to: investigating failures, executing validation protocols, and troubleshooting calibrated equipment. </span></p><p> </p><p><span style="font-family: arial, helvetica, sans-serif;">HOURS: 1st shift (6am - 2:30pm) & overtime as needed</span><br /><span style="font-family: arial, helvetica, sans-serif;">PAY: $28.19/$58,635 - $36.49/$75,899 & bonus</span><br /><span style="font-family: arial, helvetica, sans-serif;">HIRE TYPE: Direct.

Full time. Salaried non-exempt (eligible for overtime).</span><br /><span style="font-family: arial, helvetica, sans-serif;">LOCATION: Aseptic Manufacturing Facility at 7501 Page Ave St.

Louis, MO manufacturing site</span></p></div></div><div style='padding: 10px 0px;border: 1px solid transparent;'><div style='font-size:16px;word-wrap: break-word;'><H2 style='font-size: 1em; margin: 0px'><b>What You'll Do: </b></H2></div><div><ul type="disc"><li>Perform product and raw material testing of samples.</li><li>Preparation of reagents, standard solutions, equipment for use, etc.</li><li>Recognize and communicate unexpected results in a timely manner and complete Out of Specification forms (OOS), Non-conformance Reports (NCR) and Incoming Rejection Forms (IRs) for nonconforming or rejected materials.</li><li>Write and revise standard operating procedures (SOPs) under supervisor’s direction, using Quality software to change, submit and review documents.</li><li>Assists in writing validation protocols and reports.</li><li>Support and/or develop chemical testing procedures.</li><li>Support and/or develop technical requirements for raw material specifications based on input from potential vendors, product development staff, and process engineering.</li><li>Coordinate Failure Investigations by designing and performing lab scale simulation of products made in the plant.</li><li>Troubleshoot & calibrate Lab equipment.</li><li>Make recommendations on improvements to test methods and procedures.</li><li>Maintain and order lab supplies as needed.</li><li>Assist and trains Lab Techs and Specialists.</li></ul></div></div><div style='padding: 10px 0px;border: 1px solid transparent;'><div style='font-size:16px;word-wrap: break-word;'><H2 style='font-size: 1em; margin: 0px'><b>Skills, Abilities, and Experience: </b></H2></div><div><p><strong><em>Required:</em></strong></p><ul type="disc"><li>Bachelor’s Degree</li><li>4 years of relevant lab testing experience in a regulated industry (IE: FDA/ISO13485)</li><li>Knowledge of standard quality tools such as FMEA (Failure Modes Effect Analysis), Root Cause Analysis and statistics.</li><li>Ability to:</li><ul type="circle"><li>work in aseptic environment and meet gowning requirements. </li><li>wear necessary Protective Equipment (PPE).</li><li>operate independently and resolve problems of low to moderate complexity, including moderate impact decisions. </li><li>initiate action to achieve project goals.</li></ul></ul><p> </p><p><strong><em>Preferred:</em></strong></p><ul type="disc"><li>Bachelor’s degree in biology, microbiology, or other related degrees.</li><li>Expereince working in aseptic manufacturing (food, chemical, pharmaceutical etc.) environment.</li><li>Gowning and/or clean room experience. </li><li>Experience administering gowning assessments for other employees.</li><li>Strong verbal and written communication across departments, especially operations. </li></ul><p> </p><p><strong><em>Other: </em></strong></p><ul type="disc"><li>Lifting, Pushing, Pulling between 10 - 25 lbs.</li><li>Bending, walking, standing, sitting, typing, visual acuity, needed. </li><li>Aseptic laboratory environment, potential to be exposed to chemicals.</li></ul></div></div><div style='padding: 10px 0px;border: 1px solid transparent;'><div style='font-size:16px;word-wrap: break-word;'><H2 style='font-size: 1em; margin: 0px'><b>What STERIS Offers: </b></H2></div><div><p>We value our employees and are committed to providing a comprehensive benefits package that supports your health, well-being, and financial future. </p><p> </p><p>Here is just a brief overview of what we offer:</p><p> </p><ul style="list-style-type: disc;"><li>Market Competitive Pay (bi-weekly).</li><li>Benefits after 30 days.</li><li>Extensive Paid Time Off and added holidays.</li><li>Excellent Healthcare, Dental and Vision Benefits.</li><li>Long/Short Term disability coverage.</li><li>401(k) with company match.</li><li>Maternity & Paternal Leave.</li><li>Additional add-on benefits/discounts for programs such as Pet Insurance.</li><li>Tuition Reimbursement and continued educations programs.</li><li>Excellent opportunities for advancement and stable long-term career.</li></ul></div></div></div> <p>Pay range for this opportunity is $28.19 - $36.49.<span style="color:black"> This position is eligible for bonus participation.</span></p><p> </p><p>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.</p><p> </p><p>STERIS offers a comprehensive and competitive benefits portfolio.

Click here for a complete list of benefits: <a href="https://steris-corp-comm.box.com/s/pgvfuqq6urrtkov891ypp1a7bvdvn2ta">STERIS Benefits</a></p><p> </p><p>Open until position is filled.</p><p> </p><p>STERIS