Maintain document control policies, procedures, and systems in accordance with GXP regulations.
Ensure proper classification, indexing, version control, and archiving of GXP-related documents, including current and historical records.
Work in partnership with various departments to ensure GXP document accuracy and relevance.
Apogee Therapeutics is a biotechnology company seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need. They are a fast-paced company committed to building an exceptional company culture, founded on their C.O.R.E. values: Caring, Original, Resilient and Egoless.
Support registrations, submissions, and lifecycle maintenance activities.
Help maintain and improve QMS processes and records to support ISO 13485 certification.
Receive, log, review, and route product complaints for investigation.
Dandy is transforming the antiquated dental industry through technology. Backed by leading venture capital firms, Dandy is building the operating system for dental offices around the world—empowering clinicians and their teams to achieve more for their practices, their people, and their patients.
Oversee the drug substance, drug product, reference standard, and packaging/labeling/serialization contract service providers for clinical-phase and commercial production activities.
Review and approve key strategic product / process documents (i.e. specifications, batch records, tech transfer/validation protocols, etc.).
Lead, review and approve change controls, deviations, temperature excursions, investigations, OOX, CAPA, and Product Quality Complaints.
Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. Their core Values of Trust, Ownership, Curiosity and Results are foundational to every aspect of their business and are exemplified by each and every one of their team members.
Develop, update, and maintain enterprise Standard Operating Procedures (SOPs) and user guides.
Author and publish clear, user-centered release notes and communications for each system release.
Support VA training readiness activities, ensuring deliverables align with release cycles.
9th Way Insignia is a service-disabled, veteran-owned small business bringing transformative technology to our government customers. Our specialties include cybersecurity, cloud modernization, and software development.