Sr Specialist, QA Document Management
Skills
- Experience in document control and quality systems within pharmaceutical or medical device industries
- Knowledge of GxP quality systems and ICH/GxP regulations
- Proficiency with electronic document management systems, preferably Veeva Vault
- Strong attention to detail
- Excellent cross-functional communication and collaboration skills
- Proficiency in MS Word and MS Excel, with Adobe form creation as a plus
- Ability to work independently, self-motivated, and highly organized
Responsibilities
- Oversight of document control and training system effectiveness
- Manage documentation storage including archival of both electronic and paper-based records
- Review documents for completeness, grammar, formatting, and compliance with good documentation practices
- Perform administrative tasks related to electronic document and training management systems
- Issue and reconcile controlled documents and periodic review tasks
- Report and monitor document control metrics to ensure compliance
- Write, review, and approve SOPs within expertise area
- Retrieve documentation upon internal customer requests
- Provide document control support during internal and external audits or inspections
Education
- Bachelor’s degree in a related field, preferably a science degree
Benefits
- Generous vacation time and company-observed public holidays
- Volunteer days
- Long-term incentive and employee stock purchase plans or equivalents
- Employee wellbeing benefits
- Fitness reimbursement
- Tuition sponsorship
- Professional development plans
Average salary estimate
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