Responsibilities:

1 - Under direct supervision, supports Quality Assurance activities to ensure compliance with company and cGMP standards.

2- Supports Product Development and Research Senior Quality Specialist in management of Global R&D activities.

3 - Provide on the floor monitoring of Pilot Plant facilities and support areas.

4 - On-call for immediate inspections, investigations and review of possible GMP related issues. Must have the ability to support quality assessment of potential non-compliances, deviation investigation, root cause and CAPA discussion with responsible department and any required support group(s).

5. Review of R&D manufacturing and batch release documentation: 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 R&D personnel (e.g. supervisors/operators) regarding facility/ process /equipment /documentation issues.

6. Provide training/awareness related to investigation and GMP changes to R&D personnel.

7. Support continuous improvement in R&D relevant to department activities and phase of development by assisting in GxP education and quality system requirements.

8. Support conducting internal audits; assist as required with providing audit reports in a timely manner, assessment audit responses and providing quality advice to maintain regulatory compliance and continuous improvement.

9. Perform final review on applicable R&D documents and reports to ensure accuracy.

10. Assist as required with Change Control, Document Management and Electronic record activities.

Qualifications:
• Bachelor degree in a relevant scientific discipline (Pharmacy, Chemistry, Biology, Biochemistry)
• 1-2 years’ experience working in a cGMP regulated environment

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!