Quality Specialist, Computer Systems Validation

Location
Rockville, Maryland
Posted
Sep 15, 2021
Required Education
Bachelors Degree
Position Type
Full time

Your Role:

The scope of this position within the Customs Audit team as part of the Quality Assurance department includes impact to a range of important customer, operational, project or service activities within own team and other related teams or even the area. Guides and influences peers or management regarding technical issues and challenges. Affects the results within own discipline with own contributions and contributes to the technical direction or even the strategic direction and operational decision making in the field of specialization.  

 

The individual performs a variety of tasks related to auditing computer system validation as well as other documentation within the Customs Audits team as part of the Quality Assurance.  Responsibilities will include but are not limited to:

  • Review and audit computerized system validation deliverables according to 21 CFR Part 11, Annex 11 and other regulatory requirements
  • Review validation documentation – such as user requirements, functional requirements, validation plans, IQ/OQ/PQ documentation, risk assessments, test scripts, trace matrix requirements, deviations, validation summary reports, decommissioning reports and system use documentation (system admin, user admin procedures)
  • Collaborate with global, cross-functional teams to accomplish company objectives and team goals including but not limited to on-time completion of system go-lives and enhancements
  • Manage continuous improvement efforts for the computerized systems validation program
  • Provide support for GxP regulatory inspections as needed, including acting as subject matter expert for Quality GxP computer validation topics 
  • Provide Computer Validation tester/reviewer training as needed 
  • Ensure archival of validation documentation – both paper and electronic
  • Monitor industry, new/revised regulations around SDLC and CSV and guidance for impact to the organization related to computer system validation
  • Review and approve deviations / OOS records and CAPAs
  • Review and approve change control (GCC) and IT Change Control records
  • Provide guidance and/or training for Quality Specialists

 

Who You Are:
Minimum Qualifications:

  • Bachelor’s degree in a scientific (i.e. Biology, Chemistry, etc.) or a technical (i.e. Engineering, Computer Science, etc.) discipline
  • 5+ years' experience in validation, QA validation, validation tester or related technical field within a pharmaceutical, life sciences or biotechnology environment 

 

Preferred Qualifications:

  • Excellent technical writing skills and ability to document all work in an accurate and timely manner
  • Proficient knowledge of FDA and EU computer systems validation and associated regulations (cGMP, GLP, ICH, GAMP, DI, Part11)  
  • Acts ethically and ensures quality of own work and that of others
  • Collaborates with various teams to identify and implement improvements
  • Applies technology to drive digitalization, improve quality and increase customer value
  • Works with agility and drives and implements change on local and global scales