CAPA Specialist

At Proclinical, we are seeking an individual to fill the role of CAPA Specialist, based in Austin, TX.

Responsibilities

• Collect and analyze information, identify and investigate product and quality problems, and take appropriate and effective corrective and/or preventive action to reduce recurrence. Operates within the scope of EU Guidance on Good Manufacturing Practice and FDA cGMP 21CFR.
• Identify sources of product and quality problems.
• Analyze data for potential problems that may require further action.
• Verify that corrective and preventive actions have been implemented and documented.
• Report any information regarding nonconforming products and quality problems and corrective and preventive actions to the Quality Department.
• Effectively performs investigations for quality problem or nonconforming products.
• Other job-related responsibilities as required.

Skills And Qualifications

• BA in a related field and 5+ years of relevant experience.
• Knowledge of and compliance with all applicable quality and company regulations and procedures.
• Strong written, verbal, and interpersonal communication skills.
• Occasional travel required.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Kaye Dunleavy at (+1) 6463672646 or upload your resume on our website - www.Proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.