Biologics QA Specialist III

Location
Houston, Texas
Salary
Competitive
Posted
September 02 2021
Ref
143019
Discipline
Health Sciences
Organization Type
Healthcare/Hospital
The mission of The University of Texas MD Anderson Cancer Center is to eliminate cancer in Texas, the nation, and the world through outstanding programs that integrate patient care, research and prevention, and through education for undergraduate and graduate students, trainees, professionals, employees and the public.

The QA Specialist III will be responsible for quality oversight of GMP activities and for the management of quality system elements. The QA Specialist III will assist in maintaining established quality processes and will be responsible for fostering a culture of total quality throughout the Biologics Development organization.

KEY FUNCTIONS:

• Support QA functions for GMP Operations.
• Perform release of quarantine materials. Identify and assist in resolving issues related to the quarantine/rejection of materials.
• Review and Approve Line Clearance and Product Changeover.
• Issue and reconcile controlled documents for GMP operations.
• Review executed records for GMP support areas to include facilities maintenance, materials management records and QC laboratory maintenace.
• Prepare and file all executed documents for archiving per standard operating procedures.
• Review training records and ensure training documents are filed and maintained files are up to date.
• Review equipment maintenace records and ensure equipment files are up to date.
• Assist in training staff on quality procedures.
• Prepare records for off-site record storage.
• Maintain and update tracking databases as required.

Education

Required: Bachelor's degree in a related field.

Experience

Required: Three years of relevant experience. With Master's degree, one year of experience required.

Preferred: Experience with quality oversight of GMP activities and management of quality system elements.

It is the policy of The University of Texas MD Anderson Cancer Center to provide equal employment opportunity without regard to race, color, religion, age, national origin, sex, gender, sexual orientation, gender identity/expression, disability, protected veteran status, genetic information, or any other basis protected by institutional policy or by federal, state or local laws unless such distinction is required by law. http://www.mdanderson.org/about-us/legal-and-policy/legal-statements/eeo-affirmative-action.html

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