Reports To: Group Lead

Position Overview:

The incumbent is responsible for ensuring inter- and cross-shift communication pertaining to manufacturing issues, instrument troubleshooting, test scheduling, testing delays, and real time reporting EHS incidents. Additionally, you will coordinate/perform analyst training and ensures proper documentation, mentors analysts, recognizes and reacts to problems associated with laboratory procedures, performs and reviews investigations of out-of-limit results, keeps the work environment safe, and ensures shifts adhere to safety procedures/policies.

Key Responsibilities:

• Responsible for supervising daily activities of laboratory group to ensure compliance with quality and reliability standards

• Supervises the use of chemical tests and various kinds of measuring instruments in accordance with approved methods and standard operating procedures (SOPs)

• Schedules and communicates with appropriate functional groups regarding status of activities and quality testing requirements

• Provides expert review of data, protocols and reports for adherence to cGMPs and good documentation practices

• Communicates aberrant results and leads investigation to determine root cause

• Ensures quality control training and reviews and approves standard operating procedures (SOPs)

Education:

• Bachelor’s degree in a relevant scientific discipline (Chemistry, Biology, Biochemistry, etc.)

Experience:

• 3-5 years' quality control experience in the pharmaceutical/biotech/or other regulated industry

Qualifications

• Leadership/ team management skills

• Direct interaction with regulatory agencies

• Knowledge of current Good Manufacturing Practices (cGMP) principles

• Knowledge of FDA and EMA requirements

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 diversity and inclusion. Learn more about Diversity & Inclusion at CSL.

Do work that matters at CSL Behring!