HTL Biotechnology · 3 weeks ago
Senior Quality Specialist F/H
Canton, MA
Full-time
Onsite
Senior Level
7+ years expHTL Biotechnology is a global leader in the development and sustainable production of innovative pharmaceutical-grade biopolymers. The Senior Quality Specialist will ensure the quality of products and compliance with internal procedures and external standards, overseeing batch documentation, quality system events, and leading improvement projects.
BiotechnologyManufacturing
Responsibilities
Perform review of batch documentation for release of bulk drug substance, while ensuring compliance with CGMPs, site SOPs, and regulatory requirements. Prioritize record review in support of business needs including maintaining batch status and communicate release needs throughout the organization
Review and approve master batch records for the timely initiation of GxP manufacturing activities
Responsible for quality oversight and administration of the deviation/investigation and CAPA programs
Review and approve Manufacturing, Quality Control, and other investigations in support of batch release
Provide 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/Review and approve CAPAs to prevent recurrence of deviations
Review and approve Change Control documentation
Monitor, identify and propose quality process and system improvements. Lead improvement projects and communicate status to management
Serve as QA representative to cross functional project teams such as tech transfer, process validation, and process improvement
Review and approve master batch records for the timely initiation of manufacturing activities
Perform review of batch documentation for release of internal and external clinical. products/commercial products, while ensuring compliance with CGMPs, site SOPs, and regulatory requirements. Prioritize record review in support of business needs including maintaining batch status and communicate release needs throughout the organization
Provide training on department specific procedures and systems
Initiate, revise, and review controlled cGMP documents including SOPs, Material. Specifications, Investigation protocols/reports, validation protocols/reports as applicable
Ensures site readiness for regulatory inspections
Qualification
Required
Bachelor's Degree in a relevant scientific discipline preferred with a minimum of 7 years of biotech industry experience with 4+ years of experience in a QA role supporting late stage clinical and/or commercial production
Relevant experience in GMP manufacturing, specifically batch record reviews, along with batch and raw material dispositions, review of equipment validation/qualification documentation, review of calibration/maintenance documentation, and experience writing/reviewing quality systems documentation
Experience developing training documentation, work instructions, and OJTs
Experience performing RCA, technical writing, and working with quality related investigations
Knowledge of laboratory and production equipment and IQ/OQ/PQ - CFRs, CGMP, and EU Regulatory requirements
Experience developing and implementing all aspects of a robust QMS
Ability to work in a fast paced work environment
Ability to work effectively with others in a team-oriented environment and independently when needed
Ability to adapt to changing priorities
Ability to work with precision and thoroughness/detail-oriented
Possesses good organizational, communication and technical writing skills
Travel to Vendors/Suppliers to support audits
Able to translate ideas to actual concepts and processes
Able to work in a highly complex environment with competing demands and priorities
Benefits
Competitive compensation, including Bonus program
Retirement planning (5% 401k 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)
Company
HTL Biotechnology
HTL Biotechnology is a manufacturer and research & development of Hyaluronan and other biological polymers by bacterial fermentation.
201-500 employees
Funding
Current Stage
Growth StageTotal Funding
unknown2021-11-10Acquired
Leadership Team
Francis B Maddalo
Site Head/ COO
Recent News
The European Financial Review
2025-05-16
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