QA Engineer

Location
27713, Durham
Salary
TBD
Posted
Jul 19, 2021
Required Education
Bachelors Degree
Position Type
Full time

Essential Responsibilities

  • Provides quality guidance in the development and revision of computer system and equipment procedures and policies (e.g. validations, change control, security)
  • Ensures all activities related to applicable computer systems and equipment qualifications are in compliance with national/international GxPs, 21 CFR Part 11, Annex 11, Annex 15, and GAMPs
  • Performs the quality review of SOPs, policies, and the computer validation and equipment qualification master plan, as required
  • Responsible for QA oversight of the computer system validation and equipment management programs as well as working with other departments/consultants/vendors to plan, implement, and complete all validation/qualification projects (e.g. LIMS, ELN, QCBD, equipment software, etc.)
  • Responsible for system administration of Quality Management Systems (e.g. ZenQMS, Blue Mountain)
  • Responsible for electronic Archives oversight
  • Responsible for the maintenance of the Computer System Validation Status listing and Equipment Master Listing
  • Reviews and approves equipment out of tolerances investigations
  • Performs vendor qualification of vendors, contractors, consultants, and technicians that will participate in computer validation/equipment qualification activities
  • Confirms periodic reviews of validated computer systems and equipment are performed, including reviewing periodic reviews and confirm all required follow-up actions are completed
  • Responsible for QA review and approval of validation documentation for new and existing computer systems/equipment subject to validation
  • Reviews and approves for QA, deviations incident reports for executed validation and qualification documents. Ensures assignable causes are identified and addresses corrective actions, as needed
  • Serves as QA representative for the testing of the Business Continuity (e.g. IT testing) and computer system validations and equipment qualification during regulatory agency and sponsor inspections
  • Responsible for QA review and approval of change controls and Out of Tolerances to ensure timely closure
  • Perform duties with minimal QA Engineer Management oversite
  • Other duties as needed

Minimum Acceptable Qualifications

Education/Experience:

  • Bachelor's degree in engineering, information technology, computer science, or related discipline
  • Not less than five (5) years' experience in pharmaceutical/GxP/regulated environment
  • Direct hands-on experience with computer systems validation and/or equipment qualifications
  • Direct hands-on experience with GxP regulations (FDA, EPA, EU, ICH, USP, ASTM and ISO)

Skills:

  • Project management skills not required, but preferred
  • Knowledge of and technical competency in GAMP guidelines and evaluating systems lifecycle principles
  • Ability to apply validation engineering principles to the design and implementation of projects
  • Knowledge of IT infrastructure and information database systems
  • Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company procedures/policies
  • Ability to work in fast-paced environment where multiple projects are in process and must be completed in a timely manner
  • Advanced computer skills in Microsoft Office (Word, Excel, Outlook, etc.)
  • Excellent written and verbal communication skills
  • Versatility, flexibility, and willingness to work within constantly changing priorities
  • Ability to deal effectively with a diversity of individuals at all organizational levels