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.

HOURS: 1st shift (6am - 2:30pm) & overtime as needed
PAY: $28.19/$58,635 - $36.49/$75,899 & bonus
HIRE TYPE: Direct. Full time. Salaried non-exempt (eligible for overtime).
LOCATION: Aseptic Manufacturing Facility at 7501 Page Ave St. Louis, MO manufacturing site

• 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.
• Assists in writing validation protocols and reports.
• 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.
• Coordinate Failure Investigations by designing and performing lab scale simulation of products made in the plant.
• Troubleshoot & calibrate Lab equipment.
• Make recommendations on improvements to test methods and procedures.
• Maintain and order lab supplies as needed.
• Assist and trains Lab Techs and Specialists.

Required:

• 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.
• Expereince 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.

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 (bi-weekly).
• Benefits after 30 days.
• 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.