Quality Assurance Associate
Regis Technologies, Inc. is seeking a Quality Assurance Associate to join our team. This is a full-time position located in our Morton Grove, IL manufacturing facility. The Quality Assurance Associate is responsible for the execution of day-to-day quality activities related to the company-wide quality management system (QMS) with a focus on Production and Quality documentation.
Responsibilities for this position include, but not limited to:
- Reviewing Quality Control documents including raw material release data, intermediate and final product release data, as well as stability data and specification sheets
- Reviewing and approving batch records
- Inspecting cleanliness of equipment and rooms and performing line clearance
- Assisting with internal and external quality audits
- Overseeing Standard Operating Procedures and training programs
- Reviewing, approving, and maintaining databases for deviations and Out of Specifications (OOS) with a focus on root cause analysis
- Tracking quality reports for root causes and creating reports for distribution
- Inspecting materials and labels for final Active Pharmaceutical Ingredient (API) and intermediate shipment
- Reviewing Engineering work orders
Knowledge, Skills, Training, and Abilities:
- Strong knowledge of Good Manufacturing Practices (GMP) for Active Pharmaceutical Ingredients (APIs)
- Practical knowledge of FDA enforcement
- Bachelor’s Degree or equivalent combination of education and experience
- Minimum of two (2) years of Quality Assurance, Quality Control, or Manufacturing experience in a regulated GMP environment
- Proficient with the use of Microsoft Word, PDF Pro software, and Excel
- Proficient with Chromeleon is a plus
- Experience with electronic document management systems
- Competencies: attention to detail, organizational skills, teamwork, collaboration, verbal and written communication skills, project and time management, and independent judgment
The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
If you would like to become a vital part of our organization and enjoy a competitive salary with comprehensive benefits, please apply. As an equal employment opportunity employer (EOE), Regis Technologies, Inc. does not discriminate on the basis of race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, genetics, or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors.
Please email resume to:
recruiting@registech.com
Regis Technologies Inc.
8210 Austin Avenue
Morton Grove, IL 60053
NO PHONE CALLS PLEASE.