QA Analyst


Malvern, PA

Industry: Medical Devices & Diagnostics


Less than 5 years

Posted 353 days ago

  by    Raj Dakshinapu

Essential Job Functions:

  • Acts as an IT Quality representative responsible for computer system validation efforts from project inception to implementation and ongoing system support including change control
  • Creates Validation documentation including, but not limited to, System Validation Master Plans, User and Functional Requirements, Test Protocols, Scripts and Summaries, Validation Final Reports and otherrequired quality documentation for computerized systems
  • Creates Qualification documentation (plans, scripts, etc.) for Computing Environment Qualification (CEQ) efforts
  • Participates in internal and external audits of compliance for GxP computer systems
  • Assists with auditresponsibilities for IT vendor quality reviews and GxP assessments
  • Assists with management and tracking of corrective actions to audit observations
  • Participates in all IT system assessments and quality initiatives
  • Assists with development and management of IT department SOPs and other process documents
  • Follows all company environmental, health and safety policies, procedures and guidelines and conducts work in a safe manner
  • All other duties as assigned

Job Specifications (skills, knowledge, special training, certification, license requirements):

  • Knowledge of System Development Life Cycle (SDLC) methodology and practical experience conducting computer system validation and change control for off-the-shelf, as well as in-house developed systems
  • Experience with executing validation testing (IQ/OQ/PQ) of quality systems in a FDA regulated environment
  • TrackWise Quality Management Tracking System (QTMS) validation experience a plus
  • Knowledge of GAMP 5 and cGMP regulations including 21 CFR 820, and 21 CFR Part 11
  • Knowledge of FDA and ISO
  • Knowledge of Annex 11 (EU) and SOX a plus
  • Ability to work well in teams and efficiently/effectively accomplish work individually or as a team member
  • Excellent attention to details and results orientation
  • Excellent attendance and ability to work overtime, if necessary
  • Excellent organizational skills and ability to meet or exceed multiple defined deadlines when necessary
  • Must have a high degree of proficiency in personal computing applications (MS-Office)
  • Must have excellent written and verbal communication skills. Writing samples must be provided for review and evaluation.

$80K - $90K