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QA EDMS/QMS System Administrator

Company Profile

Inovio is taking immunotherapy to the next level in the fight against cancer and infectious diseases. We are the only immunotherapy company that has reported generating T cells in vivo in high quantity that are fully functional and whose killing capacity correlates with relevant clinical outcomes with a favorable safety profile. The company is advancing a growing clinical and preclinical stage product pipeline. Partners and collaborators include MedImmune, University of Pennsylvania, DARPA, GeneOne Life Science, Drexel University, NIH, HIV Vaccines Trial Network, National Cancer Institute, U.S. Military HIV Research Program, and University of Manitoba. For more information, visit www.inovio.com.

Job summary

The QA System Administrator is responsible for supporting the implementation of Pilgrim, an Electronic Data Management System (EDMS)/Quality Management System (QMS) with a cross-functional team of internal team members and third party software vendor representatives. The role administers and maintains the system in accordance with all relevant processes, procedures and requirements.

Essential job functions and duties

  • Coordinate with project staff and software third party vendor to implement, modify and maintain Pilgrim.
  • Identify, develop, refine and implement construction phase EDMS policies, procedures and work instructions.
  • Administer and maintain the EDMS system/process in accordance with project policies, procedures, and work instructions.
  • Train project staff and participants on the use of the software-based EDMS and QMS processes, procedures and work instructions.
  • Control the configuration and issuance of new workflows and content to the EDMS.
  • Post project reference documents to the EDMS.
  • Provide general assistance in Quality System management.
  • Assist with cGxP audits regarding computerized systems, including audit preparation, execution, audit report, and follow up findings.

Minimum requirements

  • College Degree or the equivalent combination of education and experience. Bachelor’s degree strongly preferred in a Life Sciences discipline or related field.
  • 3-5 years of relevant experience as an EDMS system administrator.
  • Knowledge and proficiency in the use of Pilgrim or similar document control/change control software.
  • Knowledge and proficiency in application of Quality System Requirements (QSR) and ISO13485 is desirable.
  • Knowledge of cGMP regulations and good documentation practices, especially with regard to Part 11, GAMP, and other relevant computer system control guidelines and regulations.
  • Ability to work independently, within prescribed guidelines, or as a team member.
  • Demonstrated ability to follow detailed directions in a GXP environment.
  • Must be familiar with Microsoft Office applications.
  • Detail oriented and strong written and verbal communication skills.

Disclaimer

Inovio Pharmaceuticals, Inc. is committed to a policy of equal employment opportunity. In keeping with our policy, Inovio will recruit, hire, train and promote into all job titles the most qualified individuals, without regard to race, color, creed, gender, religion, marital status, registered domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition including genetic characteristics, sexual orientation, or any other consideration made unlawful by federal, state, or local laws.

A current US work authorization is required.  The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. Inovio offers an attractive benefits package and is an equal opportunity employer.  

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