Senior QC Laboratory Specialist
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
HOURS: 1st shift (6am - 2:30pm) & overtime as needed
PAY
PAY: $28.19/$58,635 - $36.49/$75,899 & bonus
HIRE TYPE
HIRE TYPE: Direct. Full time. Salaried non-exempt (eligible for overtime)
LOCATION
LOCATION: Aseptic Manufacturing Facility at 7501 Page Ave St. Louis, MO manufacturing site
What You'll Do
- Perform product and raw material testing of samples.
- Preparation of reagents, standard solutions, equipment for use, etc.
- 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.
- Write and revise standard operating procedures (SOPs) under supervisor’s direction, using Quality software to change, submit and review documents.
- Support and/or develop chemical testing procedures.
- Support and/or develop technical requirements for raw material specifications based on input from potential vendors, product development staff, and process engineering.
- Cook up and 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 needed.
- Aid and train Lab Techs and Specialists.
Required Skills, Abilities, and Experience
- Bachelor’s Degree
- 4 years of relevant lab testing experience in a regulated industry (IE: FDA/ISO13485)
- Knowledge of standard quality tools such as FMEA (Failure Modes Effect Analysis), Root Cause Analysis and statistics.
- Ability to:
- Work in aseptic environment and meet gowning requirements.
- Wear necessary Protective Equipment (PPE).
- Operate independently and resolve problems of low to moderate complexity, including moderate impact decisions.
- Initiate action to achieve project goals.
Preferred
- Bachelor’s degree in biology, microbiology, or other related degrees.
- Experience working in aseptic manufacturing (food, chemical, pharmaceutical etc.) environment.
- Gowning and/or clean room experience.
- Experience administering gowning assessments for other employees.
- Strong verbal and written communication across departments, especially operations.
Other
- Lifting, Pushing, Pulling between 10 - 25 lbs.
- Bending, walking, standing, sitting, typing, visual acuity, needed.
- Aseptic laboratory environment, potential to be exposed to chemicals.
What STERIS Offers
- Market Competitive Pay (bi-weekly).
- Extensive Paid Time Off and added holidays.
- Excellent Healthcare, Dental and Vision Benefits.
- Long/Short Term disability coverage.
- 401(k) with company match.
- Maternity & Paternal Leave.
- 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.
STERIS Benefits
Click here for a complete list of benefits: STERIS Benefits