QAO Specialist I

CSL • Kankakee, IL

32d • $24 - $26

About The Position

This is an entry level position into Quality Assurance Operations. Developing responsibilities include assisting with investigating deviations, relevant to area of responsibility. Responsible for driving continuous improvement on production floor to ensure compliance to cGMPs. Real time review of batch records, including critical processing steps with production floor presence.

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’ 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.

Nice To Haves

• Technical writing experience is preferred.
• Proficiency in QA systems preferred.

Responsibilities

• Responsible for assisting with investigating deviations relevant to area of responsibility.
• Responsible for participating in investigation meetings with responsible department and any required support groups.
• Responsible for participating in necessary research to determine root cause, corrective/preventative actions, product disposition, and using the investigation tools provided by QAO Management.
• Collaborate with manufacturing personnel to perform root cause analysis at time deviation occurs and assist in determining robust corrective/preventive actions.
• On-call for immediate inspections, investigations, and review of possible GMP related issues and ability to provide quality assessment of potential deviation.
• Responsible for real-time review of critical in-process steps (e.g. viral reduction / sterility assurance), review/approval of completed production records, and providing immediate notification to manufacturing personnel (e.g. supervisors/operators) regarding facility/process /equipment /documentation issues.
• Execute training/awareness related to investigation and GMP changes to production personnel.
• As appropriate to area of responsibility, responsible for ensuring sample retain area is maintained in a state of compliance and all annual inspections are completed in a timely manner.
• As appropriate to area of responsibility, perform Acceptable Quality Level (AQL) assessments.

Benefits

• For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
• At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.
• CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.
• CSL Global Privacy Notice for Job Applicants and Candidates

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 1,001-5,000 employees