Shift: 12 Hour Off Shift
Overview
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.
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.
Qualifications
Education:
B.A. or B.S. degree preferably in scientific or technical field (e.g., chemistry, biology, physics, engineering, computer science, technical writing).
Experience:
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.
Technical writing experience is preferred.
The expected wage range for this position at hiring is $22.11/hour - $28.36/hour. Please note this wage range reflects what CSL expects to pay for this position at the listed location as of the time of this posting. Individual base pay for a successful candidate within this range is determined by qualifications, skill level, experience, competencies and other relevant factors.
Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.
Our Benefits
CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.
Please take the time to review our benefits site to see what’s available to you as a CSL employee.
About CSL Behring
CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.
We want CSL to reflect the world around us
As a global organization with employees in 35+ countries, CSL embraces inclusion and belonging. Learn more about Inclusion & Belonging at CSL.