Senior QC Laboratory Specialist

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.

Location: 7501 Page Ave St. Louis, MO

Hours: Monday - Friday 8hr shifts that start between 4am - 9am central. Rotating Saturdays (full days) as needed.

Hire Tpye: Direct. Full time.

Pay: $29 - 33hr

• Perform product and raw material testing of samples.
• Prepare reagents, standard solutions, equipment for use, etc.
• Recognize and communicates 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 needed.
• Assist and train Lab Techs and Specialists as needed.

Required:

• Bachelors degree in related field
• 4yrs of relevant lab testing expereince in a regulated industry
• Knowledge of standard quality tools such as FMEA (Failure Modes Effect Analysis), Root Cause Analysis, and Statistics.

Preferred:

• Bachelors in Chemistry
• Experience working in a Chemical Manufacturing environment
• GCLC expereince
• Experience and ability to work both in a lab and manufacturing floor
• Ability and drive to meet tight deadlines and work quickly and accurately

Other:

• Ability to lift, push, and pull 10-25lbs as needed
• Hand & foot manipulation
• Visual acuity

Competenecies

• Ability to work in a fast-paced environment with strict deadlines
• Empowerment: Make recommendations on improvements to test methods and procedures
• Decision Making: Make decisions on experimental steps and data analysis within defined parameters and guidelines.
• Problem Solving Authority: 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

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 Pay
Extensive Paid Time Off and (9) 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