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Specialist, QA Documentation and Training

Company: Tonix Pharmaceuticals
Location: New Bedford
Posted on: November 19, 2021

Job Description:

About TonixTonix is a global biopharmaceutical company, publicly traded on NASDAQ (ticker: TNXP). The Company is focused on discovering, licensing, acquiring, and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. Tonix's portfolio is primarily composed of central nervous system (CNS) and immunology product candidates. The immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer, and autoimmune diseases. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Please visit for specifics on the pipeline.
Position OverviewThe Specialist, QA Documentation and Training will support the development and management of the Tonix ADC facility GMP documentation and training programs and processes. The individual in this position will be responsible for managing document lifecycle processes and records retention. Also, this role will assist in establishing training requirements and materials to ensure compliance with internal and regulatory standards.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. Also, this role will provide support for the appropriate QA strategic planning of continuous improvement and reporting/escalation of quality issues and/or risk mitigation activities pertaining to clinical trial activities and to ensure a culture of quality and compliance.The Specialist, QA Documentation and Training reports into the Manager of Documentation and Training and is a member of the Quality team at the facility. The role will be based out of the new facility in New Bedford, MA once open and operational, expected in 2022. Remote work arrangements will be in place until such time.
Essential Duties

  • Support cGMP processes related to document control, training programs, and records management
  • Manage document lifecycle through creation, editing, review, issuing, and archiving with respect to batch records, test records, SOPs, and quality system records
  • Assist in maintaining role-based training curricula and training materials
  • Monitor training completion to ensure compliance with procedures
  • Train staff in use of electronic document and learning management systems
  • Ensure that records are maintained, secure, and retrievable throughout defined record retention periods
  • Issue batch records and master production records to manufacturing
  • Support internal audits as required and assist in preparation for regulatory inspections
  • Prepare and monitor metrics to ensure control of systems and drive continuous improvements
  • Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork
  • Execute special projects as necessary to support various business initiatives
    Minimum Qualifications
    • Associate degree in science or other related discipline or equivalent work experience preferred
    • Three (3) years performing document control and/or training management preferred
    • Knowledge of cGMP regulatory requirements relating to employee training and qualification, document control, and records management
    • Proficient with Microsoft Office applications (e.g., Word, Excel)
    • Experience with eDMS and LMS preferred
    • Experience with electronic training content software preferred
    • Collaborative, results-driven team player who excels in a dynamic environment
    • Dedicated team player who is able to withstand the high demands of a fast-paced environment
    • Strong written, organizational, and verbal communication skills are essential
    • Strong planning and organizational skills
    • Comfortable working independently with minimal supervision
    • Demonstrated ability to perform the essential duties of the position with or without accommodationTonix offers salary commensurate with experience and an excellent benefits package.

Keywords: Tonix Pharmaceuticals, New Bedford , Specialist, QA Documentation and Training, Other , New Bedford, Massachusetts

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