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Quality Assurance Associate

Company: Tonix Pharmaceuticals
Location: North Dartmouth
Posted on: May 9, 2022

Job Description:

About Tonix*
Tonix 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 immunology, central nervous system (CNS) and infectious disease product candidates. Tonix's immunology portfolio includes biologics to address organ transplant rejection, autoimmunity, and cancer. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix's infectious disease pipeline includes a vaccine in development to prevent smallpox, next-generation vaccines to prevent COVID-19 and an antiviral to treat COVID-19. Please visit for specifics on the pipeline.
*All of Tonix's product candidates are investigational new drugs or biologics and have not been approved for any indication.
Position Overview:
The Associate/Senior Associate, QA Operations and Compliance will support the Quality Assurance GMP Operations and Compliance function for the organization. The individual in this position will support the implementation of Quality standards and systems related to activities at the Tonix GMP manufacturing facility. The individual in this position will also execute day-to-day operations within the Quality Assurance function, including compliance oversight of internal GMP operations. In addition, the individual in this position may also oversee aspects of external manufacturing related activities.
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 and will be based at the Tonix Advanced Development Centre (ADC) facility in North Dartmouth, MA location.
Essential Duties:
Perform day-to-day operations of the Quality Assurance operations and compliance functions
Execute Quality System requirements in compliance with applicable quality standards and requirements, including but not limited to risk management, change control, deviations, CAPA, self-inspection, and complaints for internal programs
Perform lot release activities including review and approval of master and executed batch records and Certificates of Analyses
Prepare and monitor metrics to ensure control of systems and drive continuous improvements
Support internal audit program as well as participate in regulatory audits
Provide compliance support for external programs
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 initiatives
Minimum Qualifications:
Bachelor's Degree in Science or other related discipline or equivalent work experience preferred
Two (2) years of combined experience in a biotechnology/cell and gene therapy environment, covering QA, QC and/or manufacturing preferred
Background in application of cGMP in a drug substance or drug product manufacturing environment
Demonstrated troubleshooting and problem-solving skills
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
Tonix offers salary commensurate with experience and an excellent benefits package.

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

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