QA Document Control Specialist

Role Overview

• Manage document control activities within the electronic document management system (EDMS) (i.e., Veeva Quality Suite), related to Phase III and Commercial readiness associated GXP (i.e., Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Good Manufacturing Practice (GMP)) documentation
• 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
• 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

Requirements

• Bachelor's degree or relevant comparable background (e.g., biology, chemistry, pharmaceutical sciences)
• 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
• Working knowledge of electronic document management systems; Veeva Quality Vault required
• General knowledge / experience in document control, data processing, and Computer System Validation (CSV) processes related to GXP document control and training systems
• Strong attention to detail and a commitment to maintaining accuracy and compliance required
• Proficiency in Microsoft Office (e.g., MS Word, MS Excel, Teams, SharePoint), Adobe Acrobat and Smartsheet
• Exceptional organizational, communication, and problem-solving skills
• Ability to work in a fast-paced and nimble environment with a rapidly growing organization, while handling multiple priorities and projects
• Ability to collaborate and work effectively with cross-functional teams
• Familiarity of GXP regulatory requirements and quality standards
• Emerging leader with a growth mindset, willing to learn from others, and dedicated to promoting a psychologically safe environment
• Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient, and Egoless
• Ability and willingness to travel up to 10% (approximately 3-6 times per year for company meetings)

Tech Stack

• Google Cloud Platform
• Vault

Benefits

• A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless
• Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly
• Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
• We provide 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
• Apogee offers regular all team, in-person meetings to build relationships and problem solve