MindMed is hiring a
QA Specialist

Summary

Join MindMed, a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders. We are seeking a Quality Assurance Specialist to support QA needs for GCP, GLP, GMP, and GVP areas of the business.

Requirements

• Associate’s Degree or higher
• Experience and expertise in document management and control
• Proficient written and verbal communication skills
• Proficient in use of Microsoft Office applications and email
• Ability to collaborate effectively with cross functional team members and external partners
• Ability to manage multiple QA activities across multiple programs and studies
• A can-do attitude and excellent attention to detail

Responsibilities

• Reports directly to the Head of Quality Assurance (QA), supporting QA needs for GCP (Good Clinical Practice), GLP (Good Laboratory Practice), GMP (Good Manufacturing Practice), and GVP (Good Pharmacovigilance Practice) areas of the business
• Manages GMP Vendor Document archival
• Manages routing of GMP controlled documents for review and approval in the electronic quality management system (eQMS)
• Utilizes eQMS for quality workflows and for the effective tracking, trending, and reporting of quality data and information
• Prepares agenda and minutes for Quality Assurance meetings and Information Systems Steering Committee meetings, as assigned
• Performs other document organization and archival tasks as assigned
• Assists with tracking and managing non-GMP external, internal, investigator site, CSR and TMF audit activities including: Entering audits, audit findings and outcomes into the eQMS
• Tracking and filing required documentation into the eQMS
• Creating the External Audit Finding Summary and Responses template for external audits
• Maintaining the non-GMP Audit Tracker
• Assists with tracking non-GMP quality incidents, deviations and CAPAs within the eQMS
• Performs quality control (QC) checks of eQMS data on an ongoing basis (e.g., training reminders, linked documents, Q-Sheets, glossary)
• Assists with review of new and updated policies and procedures (e.g., cross check, formatting, roles)
• Assists with SOP tracking and project management of SOP development initiatives
• Assists with project management of Corporate QA Initiatives
• Performs other quality assurance support duties as assigned by the Head of QA

Benefits

• 100% paid health benefits including Medical, Dental and Vision for you and your dependents
• 401(k) program with company match and immediate vesting
• Flexible time off
• Generous parental leave