Specialist II, QA Computer Systems Validation

Location
Gaithersburg, MD, US
Posted
Oct 10, 2020
Ref
649466600
Hotbed
BioCapital
Required Education
Bachelors Degree
Position Type
Full time
Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.

I. JOB SUMMARY

The Quality Assurance Specialist II, Computer Systems Validation (CSV) is responsible for ensuring compliance of EBSI's global and multi-site computerized systems, to EBSI's global Computer Systems Standards and in alignment with applicable GxP guidance and regulations, including GAMP5, 21 CFR Part 11 (US) and EU Annex 11. These activities include Quality oversight of global and multi-site projects that include computerized systems.

II. ESSENTIAL FUNCTIONS

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

  • Review, assess and approve (as applicable) CSV related materials for all global Computerized System projects
  • Review, assess and approve (as applicable) CSV related materials for all multi-site Computerized System projects
  • Apply Global GxP requirements as part of a pragmatic validation strategy for global systems
  • Monitor, manage and revise as needed, the Global Quality Computerized System Standard
  • Establish and enhance the relationships between IT, IT CSV, and business units, through collaboration, respectful challenge, and ability to strongly support QA decisions
  • Develop and deliver CSV education and awareness materials, to enhance site level awareness of Data Integrity requirements, and associate accountabilities
  • Participate, as needed, in QA related audits of computerized systems, both internal and external.
  • Continually monitor the effectiveness of the IT CSV program, and recommend optimization opportunities as identified
  • The QA Specialist II will provide CSV guidance to the sites and will provide CSV education and awareness for corporate and sites, as needed.
  • Responsible for providing recommendations to improve and optimize the EBSI CSV strategy


The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions.

III. MINIMUM EDUCATION, EXPERIENCE, SKILLS

  • Education : Bachelor's Degree in biological or computer science, or equivalent experience in a Pharma/Biologics environment


  • Experience : Minimum of 7+ years of pharmaceutical experience with specific experience applying 21 CFR Part 11 and EU Annex 11 requirements, along with broad working knowledge of other GxP and ISO regulations and guidance, specifically related to Computer Systems Validation


  • Knowledge : Demonstrated experience in GxP best practices in a pharmaceutic/biologics environment, Global Data Integrity requirements, and/or computer systems compliance


  • Skills :
    • Ability to prepare effective reports and present to management
    • Ability to critically evaluate data summaries and conclusions
    • Proficient in all MS Office applications (Excel, PowerPoint, etc.)
    • Ability to identify and challenge CSV deliverables that do not meet standards, and recommend alternative approaches/solutions


  • Abilities :
    • An established record of successful project support for CSV, employing proven risk-based CSV principles and practice
    • Practical experience with Computer Systems Validation practices and principles.
    • Ability to think pragmatically, and apply regulatory requirements to an optimal validation strategy


IV. PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS

The physical/mental demands are representative of those that must be met by an individual to successfully perform the essential functions of the job.

The work environment characteristics described here are representative of those an individual would encounter while performing the essential functions of the job.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Travel:

Approximately 5% to 10% to other sites. May include international travel.

Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.

Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy .

Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.