Senior QC Laboratory Specialist (Aseptic)

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/$58635 - $36.49/$75899 & 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

Required:

• Bachelors Degree
• 4 years of relevant lab testing experience in a regulated industry (IE: FDA/ISO13485)
  • Clean room (ISO 5 7 8/Class B/C) environment aseptic techniques aseptic gowning environmental monitoring etc.
• Knowledge of standard quality tools such as FMEA (Failure Modes Effect Analysis) Root Cause Analysis and statistics.
• Ability towork in aseptic environment and meet gowning requirements.
• Ability to wear necessary Protective Equipment (PPE).

Preferred:

• Bachelors degree in biology microbiology or other related degrees.
• Expereince working in aseptic manufacturing (food chemical pharmaceutical etc.) environment.
• Current aseptic gowning certification.
• Experience training other technicians or specialist on process procedures and investigations.
• Experience administering gowning assessments for other employees.
• Strong verbal and written communication across departments especially operations.

Other:

• LiftingPushingPulling between 10 - 25 lbs.
• Bending walking standing sitting typing visual acuity needed.
• Aseptic laboratory environment potential to be exposed to chemicals.

• 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 supervisors 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.

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.