QC Laboratory Specialist

Position Summary

This position is responsible for performing microbiological quality testing and inspections in accordance with ISO standards, FDA Quality System Regulations (QSR), and STERIS policies and procedures. Responsibilities include the analysis of raw materials, in-process samples, and finished products using microbiological methods such as bioburden, environmental monitoring, microbial identification, and sterility testing, while assisting with contamination investigations and root cause analysis under supervision.

Hours, Pay, and Location

• Hours: 1st shift (6/7/8am start time) and overtime as needed
• Pay: $22 - $24/hr & bonus
• Location: 14905 28th Ave North Plymouth, MN
• Hire: Direct, Full time

What You'll Do

• Decontamination, cleaning, and sterilization of glassware and other containers
• Monitoring and maintenance of laboratory equipment including calibration
• Preparation of media and reagents
• Perform routine product and raw material testing of samples
• 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 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
• Participate in Investigations (complaints, failure, calibrations, equipment, etc.)

Required Skills, Abilities, and Experience

• Bachelor's Degree OR Associates Degree + 4 years relevant lab testing in a regulated industry (i.e. FDA/ISO13485) required without associates degree
• 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 communicate unexpected experimental results, interpret data with direction

Preferred Qualifications

• Bachelor's Degree in Biology, Microbiology, or similar
• Experience with plating, filtration, endotoxin testing, and aseptic technique
• Previous lab experience
• Experience collecting samples on manufacturing floor

Physical and Environmental Requirements

• Lifting/Pushing/Pulling 10-25lbs
• Bending, walking, standing, sitting, typing
• Laboratory with exposure to chemicals
• Work performed in warehouse, office, and controlled environment areas
• Must be able to work indoors in high temperatures/humidity, especially during the summer months
• May involve exposure to moving machinery, lift trucks, and hazardous substances in the warehouse area
• Must be able to walk, stand, reach both above and below shoulder height, and pull, push or lift up to 50 pounds
• Occasional bending, stooping, and crouching is required
• Frequent repetitive movement of both hands (firm or fine grasping) and good hearing, vision and color distinction

What STERIS Offers

• 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 education programs
• Excellent opportunities for advancement and stable long-term career