Quality Assurance Specialist

5 days ago


North Dartmouth, United States Tonix Pharmaceuticals Full time

**About Tonix Pharmaceuticals**

Tonix Pharmaceuticals is a biopharmaceutical company focused on commercializing, developing, discovering, and licensing therapeutics to treat and prevent human disease. We market Zembrace SymTouch (sumatriptan injection) 3 mg and Tosymra (sumatriptan nasal spray) 10 mg, indicated for acute migraine with or without aura in adults.

The company's development portfolio includes central nervous system (CNS), rare disease, immunology, and infectious disease product candidates. Our CNS development portfolio features both small molecules and biologics to address pain, neurologic, psychiatric, and addiction conditions.

We are seeking a highly skilled Quality Assurance Specialist to join our team at Tonix Pharmaceuticals' North Dartmouth, MA location. The ideal candidate will effectively perform activities related to the development and management of our quality assurance documentation and training program and processes.

Key Responsibilities:

  • Maintain processes for the Quality Assurance documentation and training program, including conducting impact assessments on the quality systems.
  • Support electronic periodic reviews of the system, including routine system updates.
  • Collaborate with cross-functional teams to align and integrate documentation and training efforts.
  • Prepare and monitor metrics to ensure the quality management system remains in control.

Qualifications:

  • Bachelor's degree in a scientific field or related discipline + five (5) years of Quality Assurance Documentation and Training experience.
  • At least three (3) years of eDMS experience preferred.
  • Demonstrated knowledge of cGMP regulatory requirements relating to employee training and qualification, document control, and records management.

We offer a competitive compensation and benefits package, including an annualized base salary ranging from $60,000 to $90,000 plus target incentive. Additional benefits include medical, dental, and vision insurance, pet insurance, retirement savings 401(k) with company match, and career development opportunities.

As a Quality Assurance Specialist at Tonix Pharmaceuticals, you will have the opportunity to work in a fast-paced environment and contribute to the success of our organization. If you are a motivated and detail-oriented professional with a passion for quality assurance, we encourage you to apply for this exciting opportunity.



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