QA Document Control Specialist
Benefits
3w PTO
Similar Jobs
See allImplementation Manager GxP
Benchling
US
CSV
SaaS
Agile
Quality and Regulatory Affairs Associate
Dandy
ISO 13485
Technical Writing
Regulatory Affairs
Senior Manager, Clinical Quality Audit & Inspection Program
Praxis Precision Medicines
US
GCP
Manager, Quality Operations, CMC
Praxis Precision Medicines
US
GMP
ISO
FDA
Senior Regulatory Affairs Manager
Jobgether
Canada
MS Office
FDA
Role Summary:
- Manage document control activities within the electronic document management system (EDMS).
- Play a critical role in ensuring that Apogee maintains the highest standards of document management and regulatory compliance.
- Support cross functional teams’ success in the advancement through every stage within the document lifecycle.
Key Responsibilities:
- Conduct regular audits of GXP documents and training processes and documents/records.
- Maintain robust quality control measures for all GXP documents.
- Stay up to date with and ensure strict adherence to GXP regulatory requirements, guidelines, and industry best practices.
Ideal Candidate:
- Minimum of 3-5 years’ Quality Assurance (QA) experience within the biotechnology or pharmaceutical industry, with 1-2 years’ direct experience within Veeva Quality Vault.
- Strong attention to detail and a commitment to maintaining accuracy and compliance required.
- Ability to work in a fast-paced and nimble environment with a rapidly growing organization, while handling multiple priorities and projects.
Apogee Therapeutics
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.