QA Document Control Specialist

Requirements

• Maintain document control policies, procedures, and systems in accordance with GXP regulations.
• Utilize Veeva Systems as a centralized EDMS for GXP documentation and employee training.
• Ensure proper classification, indexing, version control, and archiving of GXP-related documents, including current and historical records.
• Conduct regular audits (data cleaning) of GXP documents and training processes and documents/records to identify, address, and correct discrepancies and or non-compliance issues to ensure accuracy and system wellness.
• Maintain robust quality control measures for all GXP documents.
• Leverage experience with Veeva Systems to optimize document management processes and workflows.
• Provide guidance and training to staff on using Veeva for document control and compliance purposes.
• Stay up to date with and ensure strict adherence to GXP regulatory requirements, guidelines, and industry best practices (e.g., FDA, EMA, ICH).
• Work in partnership with various departments (e.g., Biometrics, Clinical, IT, Legal, Nonclinical, Program Management, Regulatory Affairs, Technical Operations, etc.) to ensure GXP document accuracy and relevance.
• Identify opportunities for improvements in GXP document and record control practices.

Benefits

• Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
• Competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave
• Commitment to growing you professionally and providing access to resources to further your development