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Senior Associate, Quality Validation

Company: Tonix Pharmaceuticals
Location: North Dartmouth
Posted on: August 7, 2022

Job Description:

Position Overview:
The Senior Associate, Quality Assurance Validation will provide compliance oversight of site GMP qualification and validation activities. The individual in this position will review and approve validation documentation, participate in cross-functional planning, and execution meetings as well as provide support for issue resolution.The individual in this position will work with the other Quality functions to ensure patient safety and compliance with FDA and other applicable global health authority requirements as appropriate. The individual in this position will also provide support for the reporting/escalation of quality issues and/or risk mitigation activities pertaining to clinical trial activities.This is a fast-paced challenging position offering a competitive compensation and benefits package. This position will report directly to the Senior Manager of Quality Assurance Operations and Compliance.Tonix is currently constructing its own Advanced Development Centre (ADC) facility which will be ready for commissioning in Dartmouth, MA in Q1, 2022. The position will be based in Tonix' ADC facility once open and operational.Essential Duties:

  • Oversee site validation activities (e.g., equipment, utilities, processes, computer system validation) to ensure compliance with cGMP
  • Review and evaluate internal validation documentation (i.e., user requirement specifications, functional specifications, protocols, reports, etc.)
  • Perform review of vendor protocols and creation of in-house supporting documentation to deliver a complete package of qualification documentation
  • Develop and implement solutions to validation related discrepancies and deviations
  • Participate in cross-functional validation planning and execution meetings
  • Prepare and monitor metrics to ensure control of validation systems and drive continuous improvements
  • Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork
  • Perform ad-hoc work/special projects as necessary to support Tonix on various business initiativesMinimum Qualifications:
    • Bachelor's Degree in Science, Engineering or other related discipline or equivalent work experience preferred
    • Five (5) years of combined validation experience within a biotechnology/pharmaceutical environment preferred
    • Ability to identify validation requirements, manage time effectively, handle multiple projects simultaneously and analyze and resolve unique situations within a manufacturing environment
    • Demonstrated troubleshooting and problem-solving skills
    • Strong foundation in application of cGMP in a drug substance or drug product manufacturing environment
    • Ability to analyze a wide variety of information and data to make decisions regarding potential risks associated with regulatory compliance
    • Dedicated team player who is able to withstand the high demands of a fast-paced environment
    • Strong planning and organizational skills
    • Comfortable working independently with minimal supervision
    • Highly organized, results driven, problem solver, and collaborator
    • Excellent written and verbal communication skills are essential
    • Demonstrated ability to perform the essential duties of the position with or without accommodation

Keywords: Tonix Pharmaceuticals, New Bedford , Senior Associate, Quality Validation, Other , North Dartmouth, Massachusetts

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