Req ID: 20345
Employment Status: AF - Active - Regular - Full Time
The Raymond G. Perelman Center for Cellular and Molecular Therapeutics (CCMT) is dedicated to the understanding, development, and application of gene and related cell and nucleic acid therapies and the promotion of professional and public education in the field. The CCMT fosters a multidisciplinary approach among researchers and scientists working to discover new gene and cell therapies in search of cures for debilitating and life threatening disorders. To support rapid translation from bench to bedside, the CCMT has the resources to manufacture a wide range of viral and non-viral vectors to transfer genes of interest and has the capability of separating and manipulating human cells for gene transfer.
One such resource is the Clinical Vector Core (CVC), a state of the art current Good Manufacturing Practices (cGMP) facility that manufactures clinical grade viral vectors and vaccines using patented vector production technology and a highly efficient purification process in compliance with regulations applicable to biological investigational drugs. Vectors are made available to researchers in the United States and abroad.
The QA Research Assistant II participates in the day-to-day operations of the Clinical Vector Core facility, with a primary responsibility to perform routine Quality Assurance and Document Control functions in support of the viral vector manufacturing process under current Good Manufacturing Practices (cGMP). This team member plays a vital role in the CVC and helps assure that non-clinical and clinical grade viral vector manufacturing complies with cGMP standards. The position requires an exceptional attention to detail; thorough, accurate and timely documentation practices; management of a digital environment for vital equipment records, the ability to prioritize multiple job responsibilities and facilitate communication across interdisciplinary groups within the CVC.
Facilitates communications between Manufacturing and Quality Control groups to achieve efficiency in timely completion of tasks in support of cGMP manufacturing and Quality Control release of gene therapy products.
Reviews, approves and archives batch production records and quality control records.
Assists manager in processing and investigating deviations, investigations, environmental excursions, out-of-specification reports in a timely manner.
Maintains and supports gowning qualification and environmental monitoring programs and schedules.
Reviews, maintains and archives training records including equipment related training. Develops and maintains equipment records assuring full cGMP compliance including digital filing system(s), records tracking and scanning, service report tracking, SOP development and maintenance and equipment logs.
Writes Audit reports as needed and presents these to CVC managers
Organizes equipment maintenance schedules and record keeping.
Supports product tracking and shipping as required
Organizes and maintains electronic logs, electronic documents and other controlled records Other routine Quality Assurance functions which may include but are not limited to material control, shipping and tracking of drug products and other biological materials, sample inventory maintenance, record archiving, etc.
Other duties as assigned.
Required Education and Experience
Bachelor’s degree, 4-6 years scientifically relevant experience required
Preferred Education, Experience & Cert/Lic
Master’s degree preferred, 1-3 years relevant experience
Bachelor’s degree, 4-6 years relevant experience required
Knowledge of Quality System regulations, guidelines, principles and practices
Document Control experience in cGMP or comparable regulated environment preferred
Experience managing equipment records in cGMP or comparable environment preferred
Annual cGMP certification
Shipping of hazardous materials training
CHOP Mandatory Training
Compliance with CHOP policies and procedures
Compliance with CVC internal Quality system standards
Additional Technical Requirements
Excellent writing and communication skills
Ability to work effectively in a fast paced team environment Strong Computer skills: Microsoft Excel, Access, Word
Strong organizational skills
All CHOP employees who work in a patient building or who provide patient care are required to receive an annual influenza vaccine unless they are granted a medical or religious exemption.
Children's Hospital of Philadelphia is committed to providing a safe and healthy environment for its patients, family members, visitors and employees. In an effort to achieve this goal, employment at Children's Hospital of Philadelphia, other than for positions with regularly scheduled hours in New Jersey, is contingent upon an attestation that the job applicant does not use tobacco products or nicotine in any form and a negative nicotine screen (the latter occurs after a job offer).
Children's Hospital of Philadelphia is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability or protected veteran status.
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2716 South Street, 6th Floor
Philadelphia, PA 19146