Quality Specialist - Deviation/CAPA

ApTask Global Workforce (AGW) is recruiting for a global biotechnology company. The Quality Specialist supports the Corporate Quality Management System team by owning and approving deviation and CAPA records, supporting the deviation management system, and contributing to process improvement.

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Responsibilities

• Own and/or QA Approve Minor and Major Deviations for the Corporate Quality Management System s (CQMS) team
• Own and/or QA Approve CAPA and Effectiveness Verification (EV) records
• Support annual trend verification report
• Support deviation proficiency evaluation program
• Support system Business Owner responsibilities such as defining user requirements, drafting data integrity assessments, drafting test scripts/protocols for user testing, and ALM testing
• Own and/or QA Approve Deviation & CAPA process documentation including work instructions, SOPs, and training materials
• Coordinate Investigation Advisory Board (IAB) meetings for multisite and CQMS deviations
• Provide support/advice to deviation management system (DQMS) users and approve IS tickets for record updates
• Review and approve Change Controls (QA Contact role)
• Apply analytical skills to evaluate and interpret complex situations/problems using multiple sources of information
• Anticipate and prevent potential problems
• Lead/support continuous improvement projects related to the Deviation/CAPA process
• Provide training for Deviation/CAPA Instructor Led Training sessions
• Independently develop solutions that are thorough, practical and consistent with functional objectives
• Bring critical events or deviations to management s attention and initiate and enforce necessary improvements and corrections

Preferred

• Experience owning/approving Major and Minor Deviations
• Technical knowledge of IS systems and validation from Business Owner perspective for systems that are used to support the Deviation process
• Excellent written and verbal communication skills
• Strong organizational skills
• Experience in AI related projects
• Knowledge of industry and business principles
• Demonstrated problem solving abilities
• Demonstrated project management skills

Benefits

• Fully remote position.
• Medical
• Dental
• Vision
• Sick Pay (for applicable states/municipalities)
• Glassdoor
• 3.8
• Information Technology and Services.
• New York, New York, USA
• http://www.genesis10.com/
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Qualifications

• Doctorate degree OR Master degree and 3 years of experience OR Bachelor degree and 5 years of experience OR Associate degree and 10 years of experience OR High school diploma / GED and 12 years of experience
• 3+ years of experience after graduating
• Experience with Deviations
• Experience with CAPA
• Overall Quality experience
• Experience owning/approving Major and Minor Deviations
• Technical knowledge of IS systems and validation from Business Owner perspective for systems that are used to support the Deviation process
• Excellent written and verbal communication skills
• Strong organizational skills
• Experience in AI related projects
• Knowledge of industry and business principles
• Demonstrated problem solving abilities
• Demonstrated project management skills

Required skills

• Artificial Intelligence, CAPA, Deviation Management, System Validation

Preferred skills

• Demonstrated problem solving abilities, Demonstrated project management skills, Excellent written and verbal communication skills, Experience in AI related projects, Experience owning/approving Major and Minor Deviations, Knowledge of industry and business principles, Strong organizational skills

Experience

• 3+ years