Bora Pharmaceuticals · 1 month ago
Analyst III, QA Document Control
Baltimore, MD
Full-time
Onsite
Mid Level
$76K/yr - $114K/yr
3+ years expBora Pharmaceuticals is seeking an Analyst III, QA Document Control who requires advanced knowledge of electronic document management systems. The role involves serving as a subject matter expert for EDMS, training others, issuing documents, and supporting regulatory inspections.
Pharmaceutical
Responsibilities
Excellent working knowledge of the electronic document management systems (EDMS) program (Veeva)
Act as a trainer on EDMS and other GDocP functions (i.e., serialization, DCC workflows, etc.)
Issue documents (batch records, logbooks, lab notebooks, etc.) in a timely manner to support site operations
Provide support during regulatory and internal inspections
Respond to internal and external audit findings
Prepare and present reports and metrics to leadership around documents (DCCs, periodic reviews, document reconciliation, etc.)
Revise Quality Assurance SOPs and Work Instructions as required to ensure procedures are compliant with cGMP
Maintain records archives both on-site and at off-site archive facility
Support cross functional teams/departments in troubleshooting technical issues related to Document Control
Additional Quality Assurance activities / support activities as required (Training of peers for document control, QA Release, etc.)
Qualification
Required
Advanced knowledge and understanding of electronic document management systems (EDMS)
Knowledgeable with GDocP and cGMPs regulations
Excellent working knowledge of the electronic document management systems (EDMS) program (Veeva)
Act as a trainer on EDMS and other GDocP functions (i.e., serialization, DCC workflows, etc.)
Issue documents (batch records, logbooks, lab notebooks, etc.) in a timely manner to support site operations
Provide support during regulatory and internal inspections
Respond to internal and external audit findings
Prepare and present reports and metrics to leadership around documents (DCCs, periodic reviews, document reconciliation, etc.)
Revise Quality Assurance SOPs and Work Instructions as required to ensure procedures are compliant with cGMP
Maintain records archives both on-site and at off-site archive facility
Support cross functional teams/departments in troubleshooting technical issues related to Document Control
Additional Quality Assurance activities / support activities as required (Training of peers for document control, QA Release, etc.)
Degree in a scientific discipline or equivalent level of skill and experience
3-5 years' experience with cGMP, FDA regulated industry, and/or electronic document management systems
Demonstrated success in independent judgment, technical proficiency, collaboration with others in a cGMP environment
Strong skills with Microsoft Office suite
Excellent attention to detail
Ability to effectively communicate (oral and written) with internal customers at all levels of the organization
Ability to work individually and as part of a team with minimal supervision
Ability to work on multiple assignments simultaneously and prioritize tasks to meet deadlines
Company
Bora Pharmaceuticals
Bora Pharmaceutical is one of the premier pharmaceutical companies in Taiwan.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
J
John W. Sheng
Founder
Recent News
2026-01-07
2025-11-14
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