Pharma Documentation Systems Specialist III

Afton Scientific. LLC; Charlottesville (VA); Sur place; USD 34 000 - 48 000; Plein temps

Résumé du poste

Afton Scientific. LLC in Virginia is seeking an experienced Documentation Systems Specialist III to maintain and control master documents and databases within a cGMP-regulated environment.

You'll support pharmaceutical manufacturing and QA operations with a focus on accuracy and traceability. Responsibilities include managing SOPs, batch records, change controls, and audits, with exposure to MasterControl/Veeva and related systems.

Qualifications

• Bachelor’s degree or minimum of five years of experience in pharmaceutical administration, documentation, or a related role.
• General experience within biopharmaceutical production or Quality Control.
• Knowledge of cGMP requirements and FDA/EU guidance for aseptic processing.
• Experience with GMP-compliant document management systems (MasterControl, Veeva, etc.).
• Advanced Word and Excel skills; ability to learn databases.

Responsabilités

• Administer and manage Afton’s Documentation Systems.
• Maintain master lists and controlled documents (SOPs, directives, policies, batch records, protocols, specifications).
• Notify clients and stakeholders of changes to controlled documents.
• Maintain records of change requests and investigation documentation.
• Assign lot numbers and issue batch records.
• Issue validation protocols and close completed protocols.
• Write, review, and edit master documents (SOPs, batch records, specs).
• Review and approve ODRs and Change Control documentation.
• Support audits and visits by facilitating documentation requests.
• Provide general administrative support as assigned.
• Support inspection activities for Finishing Operations.

Connaissances

Document control

Communication skills

Attention to detail

Independent work

Microsoft Word/Excel

Formation

Bachelor’s degree or 5+ years in pharma administration

Outils

MasterControl

Veeva

Description du poste

Afton Scientific. LLC in Virginia is seeking an experienced Documentation Systems Specialist III to maintain and control master documents and databases within a cGMP-regulated environment.

You'll support pharmaceutical manufacturing and QA operations with a focus on accuracy and traceability. Responsibilities include managing SOPs, batch records, change controls, and audits, with exposure to MasterControl/Veeva and related systems.