Quality Assurance Specialist/Senior Specialist

Armiusa; Manchester (NH); On-site; USD 85,000 - 125,000; Full time

Job summary

ARMI (Advanced Regenerative Manufacturing Institute) seeks a Quality Assurance Specialist/Senior Specialist to support GMP/GLP operations and drive quality system improvements. You will work under the Director of Quality to ensure regulatory compliance and robust quality processes across development and manufacturing activities.

Candidates should have a life sciences or engineering background, 2+ years GMP biotech quality experience, and familiarity with FDA 21 CFR Part 210 and 211.

Qualifications

• Bachelor of Science in life sciences or engineering.
• Minimum 2+ years GMP biotech/pharmaceutical quality experience.
• Knowledge of FDA regulations, 21 CFR Part 210 and 211.
• Strong written and verbal communication skills.
• Experience in fast-paced, collaborative environments.
• CDMO experience is a plus.

Responsibilities

• Improve quality system effectiveness.
• Develop, review and approve Quality System SOPs.
• Review data for GLP/GMP operations.
• Manage Quality System Events (deviations, CAPAs, risk assessments, change controls).
• Lead root cause investigations to prevent nonconformances.
• Train ARMI personnel on quality processes.
• Review master batch records for GMP Tissue Foundry processes.
• Own document control and issuance processes.
• Prepare site for audits and regulatory inspections.
• Collaborate with teams to transfer projects.

Skills

Interpersonal skills

Effective communication

Team collaboration

Initiative

MS Word

GMP experience

FDA regulations

Education

Bachelor of Science in life sciences or engineering

Job description

Overview

The Advanced Regenerative Manufacturing Institute (ARMl)IBioFabUSA is a Member-based non-profit organization founded to build the biofabrication industry and transform the future of healthcare. ARMI provides wrap-around commercialization services to companies seeking to bring life-saving regenerative technologies to patients, as well as to innovators seeking to commercialize enabling technologies that will grow the industry's impact.

The Impact That You Will Make

Quality Assurance Specialists/Senior Specialists are critical to our success. In this role, you will support quality system initiatives, ensuring compliance to federal regulations and internal operating procedures at appropriate stages during the development and manufacture of complex biologic products. Reporting to the Director of Quality, you will contribute to establishing a world-class Quality department and uphold best practices that are appropriate for our programs.

Your Role

• Be a champion for continuous improvement and identify and implement solutions to enhance quality system effectiveness
• Develop, review, and approve Quality System SOPs
• Review technical data in support of GLP/GMP operations
• Execute and track Quality System Events (e.g., deviations, CAPAs, risk assessments, and change controls)
• Participate in root cause analysis investigations to identify, mitigate, and prevent nonconformances
• Develop engaging programs to effectively train ARMI personnel
• Review and approve master batch records for GMP Tissue Foundry processes
• Own the document control and issuance processes
• Perform line clearances of manufacturing spaces
• Ensure site readiness for audits and regulatory inspections
• Collaborate with Tech Team, Program Management, and external stakeholders to facilitate technical transfer of incoming projects

Your Skills and Experiences

• Exceptional interpersonal, written and verbal communication skills
• Experience working in a fast-paced, dynamic, collaborative team environment
• High energy, commitment, initiative, and perseverance
• Bachelor of Science Degree in life sciences or engineering discipline
• Minimum of 2+ years of direct work experience in GMP biotech/pharmaceutical Quality
• Knowledge of FDA regulations, especially 21 CFR Part 210 and 211
• Exceptional written and verbal communication skills
• Comfortable executing multiple quality system efforts in a fast-paced, dynamic, and highly collaborative team environment
• Proficient with Microsoft software products, especially formatting within MS Word
• Collaborative attitude, sense of curiosity, and eagerness to impact positive change
• Experience in the CDMO business model is desired

By applying, I understand that any offer of employment is contingent upon the successful completion of a background check, in accordance with applicable laws.