Jobs 

Quality Assurance Manager

  Program in Children's Regenerative Medicine

Department of Pediatric Surgery

The University of Texas Medical School at Houston

The newly established Program in Children's Regenerative Medicine in the Department of Pediatric Surgery at The University of Texas Medical School at Houston is seeking a Quality Assurance Manager for its Human Cell Processing cGMP Facility.  A specific interest and/or expertise in cell therapy is desired. This initiative will help to save children's lives and improve the quality of their lives by developing techniques and therapies to repair damaged organs or birth defects in children.

The successful candidate will work within a human cell and tissue processing facility and will be responsible, under the guidance of the facility director, for all quality assurance and regulatory activities carried out within the facility.  He/she will be expected to assure that all production and control operations are sufficiently specified, that current Good Manufacturing Practices (cGMP) or Good Tissue Practices (cGTP) are applied according to the type of manipulation and/or use of the biological product, and will assure documentation, control and efficiency of the quality management system. Among primary responsibilities, the selected candidate will be responsible for managing quality assurance activities in the areas of Standard Operating Procedures, training and education, competency evaluation, validation, deviations, change control, investigations and CAPA, equipment qualification, records management, lot release procedures and audits. The successful candidate will also be responsible for ordinary management of documents for submission to regulatory bodies, for the compliance to all North American regulations in the field of reference, and will keep updated on all future regulations, assuring constant compliance of the facility to the highest regulatory standards of reference as well as act as a liaison for regulatory issues between the clinical team and the cell and tissue processing facility.

The Program has over 5,000 square feet of state of the art, fully-equipped basic laboratory and tissue engineering facilities as well as 4,000 square feet of cGMP laboratories for production of clinical grade, cell and tissue engineered products.

Minimum Qualifications:

• Bachelor's degree with GMP and QA training and/or 5 years working in GMP environment
• Strong background in auditing/compliance and/or experience in dealing with regulatory agencies
• Detail oriented with demonstrated capacity to communicate and organize effectively
• Demonstrated computer literacy
• Fluent in English, both written and verbal

Preferred Qualifications:

• Previous experience in this position
• Previous lab experience in cell production facility and/or blood bank
• Medical Technologist licensure

Apply Online:  http://jobs.uth.tmc.edu (Requisition #110719)

Learn more about us:  utsurg.uth.tmc.edu/pedisurgery

The University of Texas Medical School at Houston is an Equal Opportunity Employer M/F/D/V (minority/female/disabled/veteran).

Roswell Park Cancer InstituteFacility Director, Center for ImmunotherapyImmune Analysis & Therapeutic Cell Production   Roswell Park Cancer Institute (RPCI) is conducting a search for Facility Director for the Institute’s Immune Analysis & Therapeutic Cell Production Facility.  Candidates should be committed to excellence, demonstrate leadership in administrative experience, have the ability to communicate clearly, both in writing and verbally, must possess a high level of personal and administrative organizational skills for the successful conduct of site visits by regulatory agencies and day-to-day contact with customers, vendors or sales representatives.  Specialized training and significant experience in areas of immunological analysis, cell production and manipulation are required.   Minimum Qualification requirements - M.D., Ph.D. or M.D./Ph.D. degrees with background in immunology and the equivalent of three (3) years of full-time experience in Immunological Analysis and Cell Production, including eighteen (18) months experience in a supervisory, administrative, consultative, managerial or executive capacity. The Facility Director reports to the Director of the Center for Immunotherapy at Roswell Park Cancer Institute and Director of Flow Cytometry.   Candidates should submit their curriculum vitae and cover letter confidentially to Kathryn.Hall@roswellpark.org or to Kathryn Hall, RPCI Human Resources Department, Elm & Carlton Streets, Buffalo, NY 14263. Roswell Park Cancer Institute is an Affirmative Action/equal opportunity employer 

CBG Associate II

The Center for Biomedicine and Genetics (CBG) at City of Hope's Beckman Research Institute is seeking a CBG Associate II to work as a Manufacturing Associate at its GMP facility.   Responsibilities will include cell culture, virus production, document preparation (generation of SOPs, detailed protocols and batch records), materials management, and production room preparation.

The ideal candidate should have experience in cell culture (sterile technique) and be able to work with large scale culture.  The candidate should also have good organization skills and be able to communicate efficiently with team members.  Previous experience in working in a GMP environment and production of viral vector would be a plus.  The individual should be able to write protocols clearly such that others can follow.    The individual should work well independently as well as part of a team.   Previous experience with FACS analysis is an advantage as this technique may be used to monitor viral titers.  Many procedures involve production of products used in clinical trials (hence, performed under cGMP), the candidate is expected to strictly follow established SOPs and all policies.

Requirements: Bachelors Degree in biological sciences with 2-3 years post graduate biological or chemical laboratory experience. A graduate degree may substitute for work experience. Knowledge in Biology (Molecular and Cellular), Virology, and Immunology helpful.

As one of just a handful of National Cancer Institute (NCI) - designated Comprehensive Cancer Centers, City of Hope offers the opportunity to collaborate with world-renowned faculty in an academic environment. Our groundbreaking research leads to lifesaving health care benefiting our patients and millions of others worldwide.

Qualified applicants please send resume to Jocelynne Palmer via e-mail at Jmpalmer@coh.org.  City of Hope is an Equal Opportunity Employer.

Quality Assurance Associate III

The CATD is seeking a Quality Assurance Associate III responsible for assisting the QA Director and Team Leader in achieving compliance with all Federal and State laws and regulations and other accrediting agency requirements in the collection, processing, preparation, and distribution of biopharmaceutical products manufactured in the Center for Biomedicine and Genetics (CBG).  Responsibilities will include quality policy development and the supervision and training of QA associates.  Other duties will include assisting the QA team leader in the preparation/review/tracking and submission of regulatory documents, compiling project updates/reports for the QA Director and actively participating in various auditing activities.  This individual will also serve as the primary CBG QA liaison for Principle Investigators.  Support the QA Team Leader in facility related issues which include providing validation/preventative maintenance support for all equipment and facility processes.  This includes the documentation of processes and maintenance of records. 

Bachelor of Science or Associate Degree with 6 - 8 years of experience, or Masters of Science with 5 - 8 years of experience.  Basic Biology (Molecular and Cellular) Chemistry (Inorganic, Organic and Biochemistry), GMP facility operations

Biosafety courses, chemical safety, cGMP principles and practice, equipment maintenance preferred.

The Center for Applied Technology Development (CATD) at City of Hope's Beckman Research Institute is dedicated to facilitating the clinical development of innovative biologicals created by COH investigators, colleagues and partners for the benefit of patients.

Qualified applicants please send resume to Yasmine Shad via e-mail at yshad@coh.org.  City of Hope is an Equal Opportunity Employer.

Quality Assurance Associate II

The CATD is seeking a Quality Assurance Associate II is responsible for assisting the QA Director and Team Leader in achieving compliance with all Federal and State laws and regulations and other accrediting agency requirements in the collection, processing, preparation, and distribution of biopharmaceutical products manufactured in the Center for Biomedicine and Genetics (CBG).  The QAA II also assists with distribution, tracking and archiving of clinical materials.  Provides validation support for all equipment, processes, and approves all outcomes, which are essential to the production of biotechnical products.  This includes the documentation of processes and maintenance of records.  The QA II conducts audits, inspections, and staff in-service training as necessary.  Other duties include operation and maintenance of the facility monitoring systems 

Bachelor of Science or Associate Degree with 3 - 5 years of experience, or Masters of Science with 0 - 4 years of experience.  Basic Biology (Molecular and Cellular) Chemistry (Inorganic, Organic and Biochemistry), GMP facility operations

Biosafety courses, chemical safety, cGMP principles and practice, equipment maintenance preferred.

The Center for Applied Technology Development (CATD) at City of Hope's Beckman Research Institute is dedicated to facilitating the clinical development of innovative biologicals created by COH investigators, colleagues and partners for the benefit of patients.

Qualified applicants please send resume to Yasmine Shad via e-mail at yshad@coh.org.  City of Hope is an Equal Opportunity Employer.