Senior Quality Specialist F​/H

Senior Quality Specialist F/H

Join to apply for the Senior Quality Specialist F/H role at HTL Biotechnology.

Would you like to be part of an exciting journey that combines growth, innovation, and health? In an environment that merges the strength of a cutting‑edge industry with the agility of a start‑up, HTL Biotechnology is a pioneer in bacterial fermentation of hyaluronic acid and the global leader in the sustainable production of innovative pharmaceutical‑grade biopolymers. Our mission is to unlock the potential of biopolymers to improve health, quality of life, and well‑being for patients worldwide.

• Perform review of batch documentation for release of bulk drug substance, ensuring compliance with CGMPs, site SOPs, and regulatory requirements.
• Review and approve master batch records for the timely initiation of GxP manufacturing activities.
• Oversee the deviation/investigation and CAPA programs, including direction for complex investigations and CAPAs.
• Ensure timely, accurate and complete execution and documentation of quality system events: deviations, investigations, and CAPAs.
• Review, develop, and improve quality system procedures; approve CAPAs to prevent recurrence of deviations.
• Review and approve Change Control documentation and monitor quality process improvements, leading improvement projects and communicating status to management.
• Serve as QA representative to cross‑functional project teams such as tech transfer, process validation, and process improvement.
• Provide training on department‑specific procedures and systems.
• Initiate, revise, and review controlled cGMP documents including SOPs, material specifications, investigation protocols, and validation protocols.
• Ensure site readiness for regulatory inspections.

• Bachelor’s Degree in a relevant scientific discipline (preferred) with a minimum of 7 years in the biotech industry, including 4+ years in a QA role supporting late‑stage clinical and/or commercial production.
• Relevant experience in GMP manufacturing: batch record reviews, batch and raw material dispositions, equipment validation/qualification documentation, calibration and maintenance documentation, and quality systems documentation.
• Development of training documentation, work instructions, and OJTs; experience in CGMP compliance and a fast‑paced, collaborative culture.
• Experience performing RCA, technical writing, and working with quality investigations.
• Knowledge of laboratory and production equipment and IQ/OQ/PQ, CFRs, CGMP, and EU regulatory requirements.
• Implementation of all aspects of a robust QMS.
• Strong organizational, communication and technical writing skills; ability to work both independently and in a team‑oriented environment.
• Willingness to travel to vendors/suppliers to support audits.

• Competitive compensation, including a bonus program.
• Retirement planning (5% 401(k) matching).
• Comprehensive benefit plans covering medical, dental, vision, life, and disability.
• Collaborative, transparent, and inclusive culture and activities.
• Winter Break (Company observed reset and recharge, final week of the year).

HTL Biotechnology is an equal‑opportunity employer. In accordance with anti‑discrimination law, we prohibit discrimination and harassment of any type and afford equal employment opportunities to employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.

• Seniority level:
  Executive
• Employment type:
  
  Full‑time
• Job function:
  Quality Assurance
• Industries:
  Chemical Manufacturing, Oil and Gas

Position located in Canton, MA, USA.

To learn more about HTL Biotechnology, visit  or follow us on Linked In.