Senior Quality Lab Specialist (3rd Shift)
St. Louis, MO, US, 63133
At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe.
Position Summary:
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.
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.
HOURS: 11pm - 7:30am Monday to Friday *overtime as business needs
LOCATION: 7405 Page Ave St. Louis, MO
PAY: $27.88 ($58,000) - $36.50 ($75,920) + $0.75 shift differential & bonus
HIRE TYPE: Direct hire, Salaried-Nonexempt (eligible for overtime)
What You'll Do:
- Perform product and raw material testing of samples.
- Preperation of reagents, standard solutions, equipment for use, etc.
- Recognize and communicate unexpected results in a timely manner and completed Out of Specification forms (OOS), Non-conformance Reports (NCR) and Incoming Rejection Forms (IRs) for nonconforming or rejected materials.
- Write and revise standard operating procedures (SOPs) under supervisor’s direction, using Quality software to change, submit and review documents.
- Assist in writing validation protocols and reports.
- Support and/or develops chemical testing procedures.
- Support and/or develops technical requirements for raw material specifications based on input from potential vendors, product development staff, and process engineering.
- Coordinate Failure Investigations by designing and performing lab scale simulation of products made in the plant.
- Troubleshoot & calibrate Lab equipment.
- Maintain and order lab supplies as necessary.
- Assist and train Lab Techs and Specialists.
Skills, Abilities, and Experience:
Required:
- Bachelor's Degree and four (4) years relevant lab testing in a regulated industry required.
- Knowledge of standard quality tools such as FMEA (Failure Modes Effect Analysis), Root Cause Analysis, and Statistics.
- 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 to the supervisor, interpret data with minimal direction, participate in defining next step with supervisor, and retrieve information from scientific literature.
- Operate independently and resolve problems of low to moderate complexity including moderate impact decisions. Initiate action to achieve project goals.
Preferred:
- Previous work in FDA and/or ISO13485 regulated industry.
- Experience woeking with ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR and other applicable standards.
- Bachelor's degree in Chemistry, Biochemistry, or scientific field with a strong chemistry emphasis or minor.
- Previous quality work experience in a manufacturing or chemical manufacturing environment.
- GCLC experience in previous roles.
- Strong ability and experience problem solving and working independently.
Other:
- Ability to work in a laboratory setting with exposure to chemicals.
- Physical Requirements:
- Lift, Push, Pull between 10 - 25lbs at a time
- Bending, Walking, Standing, Sitting, Typing, Hand Manipulation, Visual Acuity.
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:
- Extensive Paid Time Off and (9) added holidays
- Excellent Healthcare, Dental and Vision Benefits after 45 days
- Long/Short Term disability coverage
- 401(k) with company match
- Maternity & Paternal Leave after 1yr
- 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
Pay range for this opportunity is $57,000 - $75,920. 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.
St. Louis, MO, US, 63133
Nearest Major Market: St Louis
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Testing, Infection Control, Chemical Research, Patient Care, Inspector, Technology, Healthcare, Engineering, Quality