Specialist Quality Assurance

Responsibilities

Serve as Owner or QA Contact for Minor and Major Deviations. Review validation/qualification packages of computerized systems for completeness and accuracy, sound rationale, Regulatory expectations, compliance with validation policies and procedures, and accurate data analysis. Compare results against acceptance criteria and work with appropriate departments to resolve exceptions and deviations. Bring critical exceptions or deviations to managements attention and initiate and enforce necessary improvements and corrections to established systems and processes. Initiate, implement, and track completion of Change Control and deviation requests related to computer systems. Participation and support of regulatory inspections.

• Initiate and own QA Deviations (Major, Minor) as needed
• Serve as QA contact for Major, Minor deviations
• Serve as Owner or QA contact for CAPA and Effectiveness Verification (EV) records
• Serve as Quality approver for problem records in ServiceNow
• Review and approve Requirement Specifications, Design Specifications, Testing Protocols, Validation Plans, Summary Reports, and Requirement Traceability Matrices
• Review and approve operational and administrative SOPs and Work Instructions
• Review and approve Change Controls (QA Contact role for CCMS and ServiceNow changes)
• Review and approve Data Integrity Assessments
• Review and approve System Life Cycle Documents (i.e. test protocols) before use in production.
• Applies analytical skills to evaluate and interpret complex situations/problems using multiple sources of information (e.g., Qualitative information, Quantitative research, Trend data)
• Anticipates and prevents potential problems
• May be responsible for specific GxP Computerized Systems programs and/or projects
• Independently develops solutions that are thorough, practical and consistent with functional objectives

What we expect of you

We are all different, yet we all use our unique contributions to serve patients.

Basic Qualifications:

• Masters degree and 4 to 6 years of Computer Science or related field and 5+ years of Software and Systems Quality assurance experience OR
• Bachelors degree and 6 to 8 years of Computer Science or related field and 5+ years of Software and Systems Quality assurance experience OR
• Diploma and 10 to 12 years of Computer Science or related field and 5+ years of Software and Systems Quality assurance experience

Preferred Qualifications:

• Experience owning Major and Minor Deviations
• Technical knowledge of IS systems such as LIMS, CDOCS, SAP, Maximo
• Ability to interpret and apply GxP (GMP, GLP, GCP, GPvP, GDP)
• Broad technical knowledge within own specialty area
• Knowledge of industry and business principles
• Demonstrated problem solving abilities
• Contributes to work group/team by ensuring quality of tasks/ services provided by self and others
• Provides training and guidance to others
• Extends capabilities by working closely with senior staff/ experts within and outside the internal organization
• Experience serving as QA Contact for Major and Minor Deviations
• Experience in GxP computerized systems validation