Quality Control Associate
Armiusa, Manchester, NH, United States
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 Control (QC) Associates are instrumental to supporting PD-through-GMP operations. Taking a phase-appropriate approach, QC Technicians at ARMI help to maintain the facility, materials, and processes within a state of continuous control.
The QC Associate reports to the Sr. QC Manager, and works closely with Quality Assurance, Process Development, Operations Support, and Program Management. This is an excellent opportunity for a technical professional to make an impact while learning about the cutting‑edge fields of tissue engineering and automation.
Your Role
Perform microbial and particulate sampling of ISO 7-9 cleanrooms
Assist with the identification and trending of microbial recoveries
Maintain ownership of QC equipment, ensuring units remain clean, calibrated, and validated, as necessary
Support routine lab cleaning and material inventory
Create and revise QC SOPs, test methods, and data forms
Review data and executed forms generated by other QC team members
Identify and communicate potential continuous improvements to the Quality System
Support site readiness for audits and regulatory inspections
Document all operations according to GDP
Your Skills and Experiences
Associate's or Bachelor's degree in a biological science discipline; or, 1+ year of GMP bio-/pharmaceutical manufacturing industry experience
Experience with environmental monitoring equipment ("e.g., air samplers, media plates")
Aseptic gowning experience within a controlled cleanroom environment
Familiarity with GDP, GLP, and GMP principles
Experience with electronic Quality Management Systems
Knowledge of FDA GMP regulations, especially 21 CFR Part 210, 211, 610
Strong verbal and written technical communication skills
Competency with MS Office suite, especially MS Word and Excel
Collaborative attitude, sense of curiosity, and eagerness to manifest positive change
Exceptional interpersonal, written and verbal communication skills
Experience working in a fast-paced, dynamic, collaborative team environment
High energy, commitment, initiative, and perseverance
Work Environment
Cleanroom laboratory environment with exposure to biologics, chemical reagents, and analytical instruments
Occasional weekend coverage may be required
Occasional overtime may be required to meet project deadlines
By applying, I understand that any offer of employment is contingent upon the successful completion of a background check, in accordance with applicable laws.
#J-18808-Ljbffr
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 Control (QC) Associates are instrumental to supporting PD-through-GMP operations. Taking a phase-appropriate approach, QC Technicians at ARMI help to maintain the facility, materials, and processes within a state of continuous control.
The QC Associate reports to the Sr. QC Manager, and works closely with Quality Assurance, Process Development, Operations Support, and Program Management. This is an excellent opportunity for a technical professional to make an impact while learning about the cutting‑edge fields of tissue engineering and automation.
Your Role
Perform microbial and particulate sampling of ISO 7-9 cleanrooms
Assist with the identification and trending of microbial recoveries
Maintain ownership of QC equipment, ensuring units remain clean, calibrated, and validated, as necessary
Support routine lab cleaning and material inventory
Create and revise QC SOPs, test methods, and data forms
Review data and executed forms generated by other QC team members
Identify and communicate potential continuous improvements to the Quality System
Support site readiness for audits and regulatory inspections
Document all operations according to GDP
Your Skills and Experiences
Associate's or Bachelor's degree in a biological science discipline; or, 1+ year of GMP bio-/pharmaceutical manufacturing industry experience
Experience with environmental monitoring equipment ("e.g., air samplers, media plates")
Aseptic gowning experience within a controlled cleanroom environment
Familiarity with GDP, GLP, and GMP principles
Experience with electronic Quality Management Systems
Knowledge of FDA GMP regulations, especially 21 CFR Part 210, 211, 610
Strong verbal and written technical communication skills
Competency with MS Office suite, especially MS Word and Excel
Collaborative attitude, sense of curiosity, and eagerness to manifest positive change
Exceptional interpersonal, written and verbal communication skills
Experience working in a fast-paced, dynamic, collaborative team environment
High energy, commitment, initiative, and perseverance
Work Environment
Cleanroom laboratory environment with exposure to biologics, chemical reagents, and analytical instruments
Occasional weekend coverage may be required
Occasional overtime may be required to meet project deadlines
By applying, I understand that any offer of employment is contingent upon the successful completion of a background check, in accordance with applicable laws.
#J-18808-Ljbffr