Biologics QC Specialist II

Location
Houston, Texas
Salary
Competitive
Posted
May 02 2021
Ref
139719
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 Biologics QC Specialist II is responsible for performing Quality Control Assays and Environmental Monitoring to support manufacture and release of cell therapy and viral vector products. The QC Specialist will play a vital role in performing assays to ensure the identity, quality, purity and safety of biological drug products.

KEY FUNCTIONS

• Performs analytical testing and safety testing (sterility, endotoxin, mycoplasma) on cell and viral therapy products, to verify product quality, sterility, and safety.
• Performs Environmental Monitoring of GMP Facilities including air, surface and personnel monitoring.
• Follows laboratory's quality control policies and procedures.
• Documents all quality control activities according to SOPs.
• Performs and documents equipment maintenance and calibration activities according to SOPs.
• Assists in writing new SOPs, and revising SOPs for test methods, equipment maintenance, and general laboratory practices.
• Execute daily lab responsibilities and tasks to meet assigned schedule and deadlines.
• Perform stability testing as scheduled and specified in the stability studies or protocol for cell therapy and viral supernatant products.
• Assist in performing laboratory investigations and OOS and OOT analysis.
• Assist in the execution of validation/qualification programs per ICH guidelines, cGMP and cGTP and other applicable standards.
• Assist with equipment qualification, validation programs and/or performance qualification programs.
• Reference material/standards characterization and trending.
• Assist with technology transfer activities.
• Assist area management to ensure that the lab is always in a state of readiness for a given area of relevant standards and regulations.
• Ship and receive materials and samples to support QC testing and release.
• Support inventory management for all QC lab activities.
• Review and release raw materials to be used in GMP manufacturing.
• Other duties as assigned by area manager
• Flexible work hours to maintain critical testing during manufacturing runs
• Capable of working in a fast-paced environment and communicate effectively with a diverse work group

Education

Required: Bachelor's degree in a related field.

Experience

Required: Two years of relevant experience. With Master's degree, no experience required.

Preferred: One to two years of analytical testing in a QC laboratory. Experience with cell therapy products is preferred.

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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