Position Description: The Senior QA Specialist will serve as SME by supporting investigations, risk assessments, and IT Operations while verifying that GxP computerized systems operate as expected post-validation. Responsibilities:
- Ensure IT processes and procedures meet Quality System requirements.
- Participate and support the Quality Risk Management (QRM) principles in the formal and informal risk assessment initiatives.
- Provides support and guidance with quality system records activities such as change controls, corrective and prevention action plans (CAPAs), risk assessments, data integrity initiatives, deviations, internal and external audits, standard operating procedure (SOPs), work instructions/job aids, policies, etc.
- Provide ongoing support to the Quality Auditing function with respect to IT vendors and audits.
- Support the development, review and approval of Quality Assurance Agreements (QAA), along with the Approved Supplier List (ASL) process.
- Collaborate with other functional areas to collect information and provide guidance through all stages of the quality management system and improvement projects
- Ensures new systems/processes/procedures are compliant with SOPs, WIs and data and regulatory guidelines for IT and Software validation proces
- Assist in resolution of inspection management concerns as it relates to software applications process, procedures, and data integrity
Qualifications:
- 7+ years of experience in IT, Computer Science, Engineering, or Chemistry in an FDA regulated manufacturing environment.
- Thorough understanding of IT CSV and QA IT roles and responsibilities in support of GxP compliance is required
- Experience working in an FDA regulated environment with a strong emphasis on a risk-based approach to validation/qualification
- Strong knowledge of FDA CFRs, Eudralex, and other biotech/pharma industry regulations (pertaining to IT, laboratory systems, automation, and manufacturing)
- Strong knowledge of Data Integrity, System Development Life Cycle (SDLC) validation methodology and Software Quality requirements.
- Understanding of root cause analysis and risk management techniques.
- Experience with quality management systems including change control, incident management, and deviation management
- Strong Project Management experience leading efforts requiring coordination between cross functional teams within at least one area of systems validation - e.g., laboratory equipment, facilities, utilities, manufacturing equipment, information systems, etc.
Education & Certifications:
- Bachelor's degree in a relevant field (e.g., Life Science, Computer Science, Engineering, Information Technology) preferred.