QA Analyst

About the role

Revalia is pioneering Human Data Trials a new paradigm for accelerating translational medicine by linking donated human organs to cutting-edge research. Our platform provides biotech pharma and medtech innovators with unparalleled access to human biology at scale reducing reliance on animal models and speeding the path to patients.

Location

This position is hybrid with the expectation to travel weekly to our office in New Haven CT.

Culture Requirements

• Role model theRevaliaBios Company Values of world class collaboration cultivating deep trust relentless adaptability and to persevere with uncommon grit.

• Display high levels of personal integrity and be able to express opinions or concerns directly and without triangulation demonstrating honesty openness and a positive outlookat all times.

• Seekto promote collaboration and be curious (and not judgmental) about opposing opinions.

• Ability to adapt to changing business needs or to personal development opportunities. Able to fully embrace feedback and training to continuously improve performance and relationships.

• Display determination and perseverance to problem solve create innovate and develop.

• Demonstrate commitmentto ownpersonal growth and development. Be all -in whenparticipatingin Company activities and programs related to personal and professional development and training.

• Commitment to the growth and development of their team including participation in 360 reviews whererequested.

Soft Skill Requirements

• Excellent communication and collaboration abilities with a proven track record of working effectively in team environments
• Strong problem-solving skills
• Attention to detail and commitment to quality
• Strong time management and ability to balance multiple priorities in a fast-paced environment

Technical Skill Requirements

• Basic understanding of risk management and quality systems.

• General familiarity with document controlandlearningmanagement systems or softwareis expected.

• Familiarity withTitle21CFR Parts 11 or 820 variousISOstandards and regulatory submission processes is a plus.

• Knowledge ofGMP GLP or GDP (e.g.GxP)guidelines is a plus.

Responsibilities

• Assistin the creation revision and management of quality documentation includingStandard Operating Procedures (SOPs) work instructions(Wis)and formsto ensure compliance with internal policies and regulatory requirements.

• Participate inmaintainingrecords for audits and inspections.

• Support the implementation and maintenance of the companys QMS andeQMS ensuring processes adhere to regulatory and quality standards and electronic records aremaintainedandup-to-date.

• Assistinidentifying investigating and documenting non-conformances including root cause analysis corrective and preventive actions (CAPA) and tracking the resolution of issues.

• Support the evaluation andqualificationof suppliers.

• Participate in product testing and verification activities ensuring proper documentation andreporting oftest results.

• Assistin organizing and documenting internal training programs related to quality and regulatory compliance.

• Assistin conducting internal quality audits to assess compliance with SOPs and regulatory standards and help prepare for external audits.

Qualifications

Preferred:B.S. Degree inlifescience quality assurancebusinessor related field and1years ofexperience in quality assurance preferably within the medical device biotech or pharmaceutical industries.

Accepted:A.S. Degree in life science quality assurancebusinessor related field and3 years of experience in quality assurance preferably within the medical device biotech or pharmaceutical industries.

Internship experience or academic projects related to quality control or regulatory compliance may be considered.

Compensation Benefits and Diversity Commitment

RevaliaBioacknowledges and celebrates the diversity of our workforce is dedicated to creatingan equitableworkplaceis committed to fostering an inclusive environment and aims to create a workplace culture where every individual feels a sense of an equal opportunity employer anddo not discriminateon the basis ofrace religion colornational originsex sexual orientationgender gender identity or expressionage disability or genetic makeup. For individuals with disabilities who would like to requestaccommodations please email.

Required Experience:

IC