What are the responsibilities and job description for the Quality Assurance Specialist position at Lenox Executive Search?
Lenox Executive Search is looking to hire a Quality Assurance Specialist for a contract role with one of our global pharmaceutical clients. Quality oversight is the pharmaceutical realm is a MUST!
Quality Specialist
Objectives of a Quality Assurance Specialist:
- Provides professional expertise, guidance and strong leadership in Computer System Validation and applicable regulatory requirements (21 CFR Part 11/Annex 11/GAMP 5) as applicable to the Global R&D GxP requirements (GLP, GCP, GPvP, GDP) to proactively identify compliance issues/risks in all functions within the organization and its external partners.
- Participating in the delivery of system solutions by overseeing/reviewing SDLC/CSV/Qualification activities.
- Guiding development of validation/qualification/migration/verification strategies for software (including lab), data, mobility, hardware, infrastructure/components and/or business processes prior to release into a live environment per company procedure(s).
- Overseeing execution of validation/qualification/verification/migration strategies per company procedure(s).
- Providing validation/verification/qualification guidance to stake holders as necessary.
- Managing relationships with key customers and stake holders to ensure oversight that the total validated/verified/qualified solution delivered meets/exceeds expectations.
- Ensuring SDLC/CSV/Qualification activities are conducted in a compliant and timely manner.
Accountabilities of a Quality Assurance Specialist:
- Subject Matter Expert on Company’s SDLC/Qualification procedures and regulations and able to provide guidance to IT and/or Business.
- Participate on cross functional teams to oversee validation/verification, implementation, and maintain regulated (Example: GxP, JSOX etc.) systems across Company.
- Oversee the validation/verification/qualification strategy development by working with the validation team.
- Work with project team’s offshore testers and ensures they develop appropriate test scripts based on the projects User and/or Functional requirements.
- Ensure the project testing scope is met per specified agreement and/or scope change.
- Understands the various testing activities: Unit, System, Component, User Acceptance, Performance, Integration and Regression.
- Thoroughly understands the difference between Positive versus Negative Testing.
- Insure all SDLC deliverables are completed and stored appropriately.
- Leads resolution efforts when issues are identified and escalate appropriately.
- Actively share emerging industry standards/trends with customers and peers within area of responsibility.
- Guide the response and remediation of corrective actions and internal audits.
- Cultivate and maintain contact with key customers, including IT and/or Business; working closely with vendors to complete required tasks.
- Proactively identify and assist in prioritizing opportunities to streamline validation and or qualification efforts but still stay compliant.
Education and Skills of a Quality Assurance Specialist:
-Bachelor’s degree in a life science or computer science; Master’s degree in management or scientific discipline a plus.
- Quality, R&D role, GxP systems
- Quality oversight in the pharmaceutical realm is needed!!!
- Global systems support
- Software development lifecycle knowledge helpful
- Working in Agile environment
- Infrastructure qualifications, systems validation and implementation knowledge
- Lab equipment oversight, computerized systems overview
Licenses/ Certifications of a Quality Assurance Specialist:
- American Society for Quality (ASQ)
o Certified Software Quality Engineer (CSQE)
- Quality Assurance Institute (QAI)
o Certified Software Test Engineer (CSTE)
Job Types: Full-time, Contract
Pay: $68.00 - $80.00 per hour
Schedule:
- Monday to Friday
Education:
- Bachelor's (Preferred)
Experience:
- Quality Assurance: 5 years (Required)
- pharmaceutical: 7 years (Required)
- Quality oversight: 5 years (Preferred)
Work Location:
- Multiple locations
Work Remotely:
- Temporarily due to COVID-19
Work Location: Multiple Locations