Quality Assurance Specialist/Senior Specialist

Advanced Regenerative Manufacturing Institute (ARMI) | BioFabUSA; Manchester (NH); Vor Ort; USD 85.000 - 110.000; Vollzeit

Zusammenfassung

Advanced Regenerative Manufacturing Institute (ARMI) | BioFabUSA is seeking Quality Assurance Specialists/Senior Specialists to support quality system initiatives and ensure compliance during development and manufacture of complex biologic products.

You will report to the Director of Quality, advance SOPs, manage deviations and CAPAs, and prepare for audits. A Bachelor’s in life sciences or engineering and 2+ years of GMP biotech quality experience are required.

Qualifikationen

• Bachelor of Science degree in life sciences or engineering.
• Minimum of 2+ years of direct GMP biotech/pharmaceutical Quality experience.
• Knowledge of FDA regulations, especially 21 CFR Part 210 and 211.
• Excellent written and verbal communication; collaborative team player.
• Experience in the CDMO business model is desired.

Aufgaben

• 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 analyses to identify, mitigate, and prevent nonconformances.
• Prepare engaging programs to 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.

Kenntnisse

Interpersonal communication

Written communication

Verbal communication

Team collaboration

GMP knowledge

FDA regulations

MS Word

Microsoft Office

Problem solving

Ausbildung

Bachelor of Science in life sciences or engineering

Tools

MS Word

Jobbeschreibung

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.