Senior Documentation Systems Specialist (GMP/QA)

Initial Therapeutics, Inc.; Virginia (IL); On-site; USD 34,000 - 48,000; Full time

Job summary

Afton Scientific in Virginia seeks an experienced Documentation Systems Specialist III to join our Quality Assurance team. You will manage master documents, control databases, and coordinate SOPs, batch records, and specifications, ensuring compliance with cGMP and regulatory expectations.

Qualified candidates have a bachelor's degree or 5+ years in pharmaceutical documentation, hands-on experience with MasterControl or Veeva, strong writing and communication skills, and the ability to work with

Qualifications

• Bachelor's degree or 5+ years in pharma admin or related role.
• GMP/cGMP knowledge for aseptic processing.
• Experience with GMP-compliant DMS such as MasterControl or Veeva.
• Excellent Word/Excel and ability to learn new databases.
• Strong written and verbal communication; detail-oriented.

Responsibilities

• Support overall administration and management of Documentation Systems.
• Maintain master lists and approved controlled documents incl. SOPs, directives, policies, batch records, protocols, specifications.
• Notify clients and stakeholders of changes to controlled documents.
• Maintain records of approved 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 including SOPs, batch records, specifications.
• Review and approve ODRs and Change Control documentation as applicable.
• Support audits and pharmaceutical VIP visits by facilitating documentation requests.
• Provide general administrative support as assigned.
• Provide inspection support to Finishing Operations, as qualified.
• Maintain positive working relationships with coworkers, internal customers, and vendors.

Skills

Attention to Detail

Documentation Skills

GMP Knowledge

cGMP Knowledge

MasterControl/Veeva experience

MS Word & Excel

Communication Skills

Independent Work Style

Regulatory Compliance

Education

Bachelor's degree or 5 years experience in pharmaceutical administration

Tools

MasterControl

Veeva

Job description

Afton Scientific in Virginia seeks an experienced Documentation Systems Specialist III to join our Quality Assurance team. You will manage master documents, control databases, and coordinate SOPs, batch records, and specifications, ensuring compliance with cGMP and regulatory expectations.

Qualified candidates have a bachelor's degree or 5+ years in pharmaceutical documentation, hands-on experience with MasterControl or Veeva, strong writing and communication skills, and the ability to work with