Job Description

**Position Summary: **

This position is responsible for performing quality inspection in accordance with the requirements for ISO, FDA QSR, and STERIS policies. This would include but is not limited to testing raw material, in-process, and finished goods using the various analytical instrumentation (i.e. HPLC, GC) and with supervision perform failure investigation.

Schedule: 10pm - 6:30am Monday through Friday & overtime as needed

Pay Range: $21.86 - $28.29 / $45,468.80 - $58,843.20 paid bi-weekly

Hire Type*: *Full Time, Direct, Salaried: Non-Exempt (eligible for overtime pay)

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.)

Skills, Abilities, and Experience:

Required:

• Bachelors Degree OR Associates Degree +4yrs of experience.
• Minimum 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 communicates unexpected experimental results, Interpret data with direction.

Preferred:

• Any previous experience working in a similar regulated industry - internships included.

• Degree in Chemistry or Biochemistry.

• Previous work experience in a quality control setting or chemistry lab.

Other:

• Lifting, Pushing, Pulling 10-25lbs
• This position requires that work be performed in warehouse, office, and controlled environment areas.
• Individual must be able to work indoors in high temperatures/humidity, especially during the summer months.
• This position may involve exposure to moving machinery, lift trucks, and hazardous substances in the warehouse area.
• Individual 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.
• This position requires frequent repetitive movement of both hands (firm or fine grasping) and good hearing, vision and color distinction.

You should be proficient in:

• ISO 13485
• FDA Regulations
• ISO 9001 Certification Experience