Quality Assurance Specialist 1

CSL•Kankakee, IL

2d•$23 - $29•Onsite

About The Position

This is an entry level position into Quality Assurance Operations. Responsibilities include real time production floor monitoring. Real time review of batch records, including critical processing steps, as well as all other ancillary manufacturing and support systems documentation. Assisting with investigating deviations, relevant to area of responsibility. Responsible for supporting continuous improvement on production floor to ensure compliance to cGMPs.

Requirements

B.A. or B.S. degree preferably in scientific or technical field (e.g., chemistry, biology, physics, engineering, computer science, technical writing).
0-2 years of experience working in a cGMP regulated environment such as the field of quality, manufacturing or engineering field, applying the cGMP rules in everyday activities.
Proficiency in Microsoft Office and QA systems.

Nice To Haves

Technical writing experience is preferred.
Knowledge of cGMP standards preferred.

Responsibilities

Responsible for real-time review of critical in-process steps, review/approval of completed production records, and providing immediate notification to manufacturing personnel (e.g. supervisors/operators) regarding facility/ process /equipment /documentation issues.
Real time floor monitoring for process adherence, safety and quality issues, and reporting of any findings through the eQMS or department or Quality escalations as appropriate.
Responsible for participating in investigation meetings with responsible department and any required support group(s) to help determine root cause, corrective/preventative actions, and product disposition.
On-call for immediate inspections, investigations, and review of possible GMP related issues and ability to provide quality assessment of potential deviation.
Execute training/awareness related to investigation and GMP changes to production personnel.
Support continuous improvement on production floor to ensure compliance to cGMPs.
As appropriate to area of responsibility, perform Acceptable Quality Level (AQL) assessments.
Complies with requirements from CSL Behring’s Safety Program, including Health and Safety mandates and OSHA requirements.
Provide awareness training on deviations to department personnel.