QA Document Control Specialist

📋 Description

• Document Control: Maintain policies, procedures, and systems per GXP regs.
• Use Veeva EDMS for GXP docs and staff training.
• Ensure proper classification, indexing, versioning, and archiving of GXP docs.
• Conduct regular audits of GXP docs and training records for accuracy.
• Maintain robust quality control measures for all GXP docs.
• Provide guidance and training on Veeva for document control and compliance.

🎯 Requirements

• Bachelor's degree or relevant background (biology/chemistry/pharma).
• 3-5 years QA in biotech/pharma; 1-2 yrs with Veeva Quality Vault.
• Proficient with Veeva EDMS; strong GXP document control.
• Knowledge of FDA/EMA/ICH GXP regs and compliance.
• Proficient in MS Office, Adobe Acrobat, Smartsheet; SharePoint/Teams.
• Excellent attention to detail and cross-functional collaboration.

🎁 Benefits

• CORE values culture: Caring, Original, Resilient, Egoless.
• Dynamic, fast-paced environment with growth opportunities.
• Competitive compensation: base, bonus, equity; health/retirement; $85k-$100k.
• Generous PTO and company shutdown weeks, paid sick leave.
• Professional development resources and learning opportunities.
• Regular all-team in-person meetings to build relationships.