Documentation Specialist

Scorpion Therapeutics; Pennsylvania; On-site; USD 65,000 - 95,000; Full time

Job summary

Scorpion Therapeutics is seeking a dedicated Business Archives Coordinator to manage the GxP documentation lifecycle at our Swiftwater site. You will collaborate cross-functionally to ensure regulatory alignment, maintain lean, accurate documentation, and support audits with up-to-date, retrievable records.

Responsibilities include archiving, third-party liaison, and driving digital transformation via AI-enabled workflows, with strong emphasis on data literacy and tool proficiency (CMS, Veeva

Qualifications

• Bachelor’s degree or higher preferred.
• 4+ years of document management, continuous improvement, and cross-functional process involvement (pharma preferred).
• Experience with digital tools and AI-enabled platforms to streamline workflows and improve accuracy/retrieval.

Responsibilities

• Manage the GxP documentation lifecycle (creation, revision, obsolescence).
• Collaborate with other departments to ensure documentation addresses business needs and processes.
• Ensure documentation content is compliant with regulatory requirements and company standards.
• Keep documentation packages lean (avoid redundancies/duplication).
• Ensure documentation accuracy, completeness, and compliance with writing rules (clarity/grammar).
• Collect documentation change needs; prioritize and manage updates.
• Ensure documents remain current and aligned with evolving needs/processes.
• Ensure document distribution and access comply with information classification level.
• Support internal/external audits and inspections by ensuring documents are up-to-date and retrievable.
• Support record retention archiving procedures as a Business Archives Coordinator (BAC) for the Swiftwater site.
• Liaison with approved third-party storage subcontractors; provide guidance on archiving tools/processes.
• Support annual archival eligibility reviews.
• Serve as backup CMS Community of Practice (CoP) representative; participate in Centers of Excellence (CoE) when requested.
• Support CMS user training, access management (CMS Care requests), and weekly high-priority Document Change Request (DCR) reporting.

Skills

AI-enabled platforms

CMS

Veeva Vault

Adobe Acrobat

Microsoft Office

Data literacy

communication

problem solving

automation / AI piloting

Education

Bachelor’s degree preferred

Tools

Veeva Vault

CMS

Adobe Acrobat

Microsoft Office

Job description

Main Responsibilities

• Manage the GxP documentation lifecycle (creation, revision, obsolescence).
• Collaborate with other departments to ensure documentation addresses business needs and processes.
• Ensure documentation content is compliant with regulatory requirements and company standards.
• Keep documentation packages lean (avoid redundancies/duplication).
• Ensure documentation accuracy, completeness, and compliance with writing rules (clarity/grammar).
• Collect documentation change needs; prioritize and manage updates.
• Ensure documents remain current and aligned with evolving needs/processes.
• Ensure document distribution and access comply with information classification level.
• Support internal/external audits and inspections by ensuring documents are up-to-date and retrievable.
• Support record retention archiving procedures as a Business Archives Coordinator (BAC) for the Swiftwater site.
• Liaison with approved third-party storage subcontractors; provide guidance on archiving tools/processes.
• Support annual archival eligibility reviews.
• Serve as backup CMS Community of Practice (CoP) representative; participate in Centers of Excellence (CoE) when requested.
• Support CMS user training, access management (CMS Care requests), and weekly high-priority Document Change Request (DCR) reporting.

Basic Qualifications

• Bachelor’s degree preferred.
• 4+ years of document management, continuous improvement, and cross-functional process involvement (pharma preferred).

Preferred Qualifications / Skills

• Experience with digital tools and AI-enabled platforms to streamline workflows and improve accuracy/retrieval.
• Working knowledge of CMS and digital lifecycle management platforms (e.g., Veeva Vault).
• Familiarity with AI-assisted document processing (intelligent search, automated classification, OCR, generative AI).
• Comfort with paperless/digital transformation (Fly, MOSAIC); support change management.
• Data literacy; interpret dashboards/reports.
• Proficiency with CMS, Adobe Acrobat, Microsoft Office, Veeva Vault.
• Strong communication, analytical problem-solving, decision-making; manage multiple priorities.
• Ability to evaluate/pilot/champion AI and automation solutions.

Languages

• English required (verbal and written).