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Auditor

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CSL Behring

2021-12-03 08:50:48

Job location Boca Raton, Florida, United States

Job type: fulltime

Job industry: Other

Job description

Job Description

Responsibilities:
• Under general supervision, maintains Quality Assurance System to ensure compliance with company and cGMP standards
• Responsible for maintaining audit program, reviewing functional and release documentation and investigating deviations relevant to area of responsibility
• Reviews lot release documentation and facilitates compliant release process for corresponding market
• Responds to questions from authorities (Swissmedic, FDA, etc.) to ensure timely product release
• Ensures standard operating procedures (SOP's) stay current and align with corporate and regulatory requirements
• Executes training/awareness related to GMP standards

Qualifications:
• University degree in a relevant scientific discipline (Pharmacy, Chemistry, Biology, Biochemistry)
• 3+ years' GMP experience in pharmaceutical/biotech or other regulated industry
• 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.

About Us

Our Benefits

We encourage you to make your well-being a priority. It's important and so are you. Learn more about how we care at CSL.

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 organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at CSL.

Do work that matters at CSL Plasma!

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