6343 - Quality Lead / Quality Engineer
About The Position
Verista's team of experts collaborates with recognizable brands in the life science industry to solve business needs, focusing on empowering growth and innovation within the scientific community. The company provides innovative solutions and services that result from significant investment in its people and capabilities, aiming to help researchers and companies solve pressing healthcare challenges. Verista emphasizes a people-focused culture with guidelines and values centered on empowering and supporting colleagues, committing to client success, having the courage to do the right thing, fostering an inclusive environment, and continuously enhancing expertise through learning. This position supports the Quality Information Systems Management (QISM) group, working closely with operational and other business/QA groups. The role facilitates regulatory/data integrity assessments, change control review requirements gathering, design, and system validation. It involves performing quality oversight functions and taking quality ownership for computerized system projects, with a specific focus on Manufacturing and Analytical Laboratory systems.
Requirements
- Bachelor’s degree in IT or Computer Science
- 6-10+ years of proven experience in computerized systems, Enterprise Level and Lab systems validation/quality capacity
- Familiarization with ITIL/GAMP5 Validation Lifecycle
- Proven analytical abilities
- Practical experience generating process documentation and reports
- Excellent communicator with the ability to translate data into actionable insights
Nice To Haves
- Strong working knowledge of relevant computerized systems module, structure design
- Proven capabilities in project and user-testing management
- Proven development of innovative and impactful systems solutions
- Highly proficient technical writing capabilities
- Knowledge of Agile validation lifecycle and methodologies.
- Experience with Veeva VQMS, ServiceNow and Application Lifecycle Management with e-signature (ALM) system is highly desirable.
Responsibilities
- Provide Quality oversight on Enterprise Level, ServiceNow, QMS, ERP, Veeva EDC, Compass, RIM, Data analytics platforms, Manufacturing Systems, and Lab Systems projects.
- Take Quality ownership, participate in cross-functional team discussions, and provide quality guidance/decisions for projects including New implementation, Enhancements, Quarterly releases, Periodic reviews, and review/approve Quality events (deviations & CAPS).
- Participate and drive System Assessments, review and approve project deliverables, including plans, test scripts, execution outcomes, reports, and traceability.
- Participate and drive discussions to resolve issues while adhering to quality compliance.
- Embrace Data Integrity integral to system projects.
- Highlight identified quality risks and present possible mitigation options to the project team, keeping them informed of quality management.
- Perform, evaluate, and communicate thorough quality assurance at every stage of systems development/implementation.
Benefits
- High growth potential and fast-paced organization with a people-focused culture
- Competitive pay plus performance-based incentive programs
- Company-paid Life, Short-Term, and Long-Term Disability Insurance.
- Medical, Dental & Vision insurances
- FSA, DCARE, Commuter Benefits
- Supplemental Life, Hospital, Critical Illness and Legal Insurance
- Health Savings Account
- 401(k) Retirement Plan (Employer Matching benefit)
- Paid Time Off (Rollover Option) and Holidays
- As Needed Sick Time
- Tuition Reimbursement
- Team Social Activities
- Employee Recognition
- Employee Referral Program
- Paid Parental Leave and Bereavement
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
