The Opportunity

You will be responsible for optimizing quality performance of assigned business areas.

This is a remote opportunity. You will report to the Operations Project Lead.

The Role

• Serve as the Subject Matter Expert on the applicable quality systems for deviations management, change management and validation programs for US CSL Plasma.

• Investigate and assess risks associated with incidents which warrant investigation.

• Responsible for maintaining or developing the systems necessary for effective Deviation Resolution, Corrective and Preventive Action (CAPA) and Change Control processes to support the quality systems improvements identified.

• Maintain a thorough understanding of the relevant regulations and guidelines: Food & Drug Administration (FDA), Clinical Laboratory Improvement Amendments (CLIA), current Good Manufacturing Practices (cGMP), corporate policies and procedures, FDA's guidance on Validations, all relevant Medical Device Directives, and other applicable standards.

• Support the validation program improvements necessary to ensure compliance with FDA, German Health Authority (GHA), state and all other applicable regulatory requirements and best industry practices. Lead the verification and validation of new processes and products consistently meets user needs and specifications.

• Effectively collaborate with other departments in designing and executing validation plans and protocols to minimize risk and impact. Plan, prepare and review validation activities and summary reports for team members and self. Assess, verify, or validate new processes and equipment to ensure that user needs and specifications are consistently met.

Your skills and experience

Education

Bachelor’s Degree in Sciences or Engineering, OR equivalent combination of education, training and relevant work experience required.

Experience

• ASQ Certification preferred

• Minimum 5 years experience in a regulated environment required

• Minimum 2 years’ experience in a Quality role, preferably in a highly regulated industry.

#LI-Remote

Our Benefits

CSL offers the following benefits for this full-time position: Options for health care benefits, including choices of plans for medical, dental, and vision, prescription drug coverage; Company-provided basic life insurance and Short- and Long-Term Disability; the option to participate in CSL’s 401(k) Savings Program; Paid Time Off (PTO) for use in connection with vacations, illness, and other personal business; and paid observed holidays as designated by the Company.  For more information on CSL Plasma benefits visit https://cslbenefits.com/cslp.

About CSL Plasma

CSL Plasma is one of the world's largest collectors of human plasma. Our work helps to ensure that people with rare and serious diseases are able to live normal, healthy lives. We are committed to our work because lives depend on us. Learn more about CSL Plasma.

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 Plasma!