Job Title:  QC Laboratory Specialist (Aseptic Lab)

Position Summary

The 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 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.

Duties

1. Decontaminates, cleans, and sterilizes glassware and other containers.
2. Monitors and maintains laboratory equipment including calibration.
3. Prepares media and reagents.
4. Performs routine product and raw material testing of samples.
5. Performs product and raw material testing of samples.
6. Prepares reagents, standard solutions, equipment for use, etc.
7. Recognizes and communicates unexpected results in a timely manner and completes Out of Specification forms (OOS), Non-conformance Reports (NCR) and Incoming Rejection Forms (IRs) for nonconforming or rejected materials.
8. Writes and revises standard operating procedures (SOPs) under supervisor’s direction, using Quality software to change, submit and review documents.

Participates in Investigations (complaints, failure, calibrations, equipment, etc.)

Education Degree

Required Experience

Number of years’ experience and type accepted in lieu of the above:

4 years experience required with Associate’s degree in a regulated industry (i.e. FDA / ISO13485)

Minimum 6 years relevant lab testing in a regulated industry (i.e. FDA/ISO13485) required without associates degree

Required Skills or Competencies

1. Ability to work in a fast-paced environment with strict deadlines

2. Empowerment:  Make recommendations on improvements to test methods and procedures

3. Decision Making:  Make decisions on experimental steps and data analysis within defined parameters and guidelines.

4. Problem Solving Authority: Recognize and communicates unexpected experimental results, Interpret data with direction.