Regulatory Compliance Specialist

1 month ago


Manchester, New Hampshire, United States ADVANCED REGENERATIVE MANUFACTURING INSTITUTE Full time
Job Summary

As a Quality Assurance Associate at the Advanced Regenerative Manufacturing Institute, you will play a crucial role in ensuring the alignment of our PD-through-GMP process with regulatory expectations. This position requires a strong understanding of quality management systems and the ability to translate regulatory requirements into actionable controls.

About the Role

As a Quality Assurance Associate, you will be responsible for assisting with the onboarding and oversight of our electronic Quality Management System. You will also manage document control and issuance, draft SOPs, and coordinate their review and approval. Additionally, you will facilitate training programs, track Quality System Events, and review data and executed forms for GDP compliance.

Responsibilities

* Assist with onboarding and oversight of an electronic Quality Management System
* Manage document control and issuance
* Draft SOPs and coordinate their review and approval
* Facilitate training programs
* Track Quality System Events (e.g., deviations, CAPAs, risk assessments, and change controls)
* Review data and executed forms for GDP compliance
* Identify potential continuous improvements to the Quality System
* Manage record retention for data and Quality System files
* Provide formatting review to documentation as needed for consistency of style, voice, and appearance
* Ensure site readiness for audits and regulatory inspections

Requirements

* Associate's or Bachelor's degree with 2+ years of experience in GMP biotech/pharmaceutical Quality role
* Strong verbal and written technical communication skills
* Experience with electronic Quality Management Systems
* Competency with MS Office suite, especially formatting within MS Word and Excel
* Knowledge of FDA GMP regulations is desired, especially 21 CFR Part 210, 211, and 600
* Collaborative attitude, sense of curiosity, and eagerness to impact positive change

About Us

The Advanced Regenerative Manufacturing Institute is a leading organization in the field of regenerative manufacturing. Our mission is to develop a highly diverse, competitive, capable, and innovative domestic cell, tissue, and organ-manufacturing ecosystem that will fundamentally change healthcare for chronic disease and traumatic injury. We are committed to establishing the trained and ready workforce essential for that ecosystem, centered in Manchester, NH. Our goal is to improve lives by cost-effectively restoring or replacing the function of damaged cells, tissues, and organs for patients and warfighters.

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