Job Details

Specialist Quality AssuranceLocation: Providence RI Contract Duration: 12 monthsPrimary Responsibilities:Own and/or QA Approve Minor and Major Deviations for the Corporate Quality Management System's (CQMS) team – Deviation/CAPA functional area and Corporate functions that do not have Quality oversightOwn and/or QA Approve CAPA and Effectiveness Verification (EV) recordsSupport annual trend verification reportSupport deviation proficiency evaluation programSupport system Business Owner responsibilities such as defining user requirements, drafting data integrity assessments, drafting test scripts/protocols for user testing, ALM testingOwn and/or QA Approve Deviation & CAPA process documentation including work instructions, SOPs, and training materialsCoordinate Investigation Advisory Board (IAB) meetings for multisite and CQMS deviationsProvide support/advice to deviation management system (DQMS) users and approve IS tickets for record updatesReview and approve Change Controls (QA Contact role)Apply analytical skills to evaluate and interpret complex situations/problems using multiple sources of information (e.g., Qualitative information, Quantitative research, Trend data)Anticipate and prevent potential problemsLead/support continuous improvement projects related to the Deviation/CAPA processProvide training for Deviation/CAPA Instructor Led Training sessionsIndependently develop solutions that are thorough, practical and consistent with functional objectivesBring critical events or deviations to management's attention and initiate and enforce necessary improvements and corrections to established systems and processesAdmin activities may include the following: maintenance of Deviation/CAPA Smartsheets and distribution lists, querying in deviation management system for data collection/analysis, data gathering for metricsPreferred QualificationsExperience owning/approving Major and Minor DeviationsTechnical knowledge of IS systems and validation from Business Owner perspective for systems that are used to support the Deviation processExcellent written and verbal communication skillsStrong organizational skillsExperience in AI related projectsKnowledge of industry and business principlesDemonstrated problem solving abilitiesDemonstrated project management skillsContributes to work group/team by ensuring quality of tasks/ services provided by self and othersProvides training and guidance to othersExtends capabilities by working closely with senior staff/ experts within the internal organizationSalary and Other Compensation: The annual salary for this position is between $28.00 - $29.00 per hour. Factors which may affect pay within this range may include geography/market, skills, education, experience, and other qualifications of the successful candidate.Benefits: The Company offers the following benefits for this position, subject to applicable eligibility requirements: [medical insurance], [dental insurance], [vision insurance], [401(k) retirement plan], [life insurance], [long-term disability insurance], [short-term disability insurance], [paid parking/public transportation], [Paid time off], [Days/hours of paid sick and safe time], [Days/hours of paid vacation time], [Weeks of paid parental leave], [Paid holidays annually], [any additional benefits applicable].