Document Specialist

Job Title: Document Specialist 
Location: Onsite/Pittsburgh, PA 15219
Type: Direct-Hire
Start date: End of May

Overview: 
Join an innovative biotech team at the forefront of Cell and Gene Therapy! We are seeking a Document Specialist to manage critical documentation and support quality assurance within a cutting-edge GMP environment. You’ll create and manage SOPs, batch records, and controlled documents using an electronic quality management system (eQMS), while ensuring compliance with Good Documentation Practices (GDP),  if you are interested in learning more please apply !

Responsibilities:

• Document Creation, Formatting, and Editing:
  Create, format, and edit Standard Operating Procedures (SOPs), batch records, and other forms according to company standards and regulatory requirements.
• Electronic Document Management System (EDMS):
  Manage the EDMS, ensuring the timely routing, review, and approval of documents. Ensure controlled documents are appropriately organized, maintained, and accessible.
• Review Management:
  Track and manage document review deadlines and ensure subject matter experts (SMEs) and other responsible parties adhere to timelines assigned by QA.
• Consistency and Quality Review:
  Perform content and quality consistency checks for all documentation, ensuring alignment with established quality standards, templates, and regulatory requirements.
• Deviation and Out-of-Specification (OOS) Support:
  Assist the Quality Assurance (QA) team in managing deviations and out-of-specifications, ensuring documentation is properly reviewed, filed, and closed out as per procedural timelines.
• Good Documentation Practices (GDP):
  Enforce GDP across all documentation-related activities to maintain data integrity, clarity, and accuracy in all official records.
• Training Management:
  Assist in creating and organizing training materials and records, including tracking training completions and retraining needs for personnel.
• Audit Support:
  Support QA in defending documentation and records during regulatory inspections or sponsor audits, ensuring that all required documents are accurate, up-to-date, and audit-ready.
• Batch Record Issuance:
  Collaborate with QA to prepare and issue batch records for manufacturing processes, ensuring they are appropriately documented and tracked.
• Document Control and Obsolescence Management:
  Physically replace outdated SOP hardcopies with the most effective version at all relevant locations, ensuring only current documents are available for use.
• SME Collaboration:
  Reconcile edits and revisions from subject matter experts (SMEs), ensuring that all changes are accurate and incorporated into final documents.
• Formatting and Standardization:
  Ensure all documents follow consistent formatting, structure, and language in compliance with company style guides and regulatory standards.
• Process Improvements:
  Recommend and implement improvements to documentation processes and systems to enhance efficiency, compliance, and user experience.

• Bachelor’s degree in a related field (life sciences, technical writing, or regulatory affairs preferred).
• 2 years of experience in document control, technical writing, or quality systems management in a GMP-regulated environment (preferably cell and gene therapy or biotech).
• Proficiency in using electronic document management systems (EDMS).
• Strong understanding of Good Documentation Practices (GDP) and quality management systems.
• Excellent communication skills, both written and verbal, with a keen attention to detail.
• Ability to manage multiple priorities and meet deadlines in a fast-paced environment.
• Experience supporting regulatory inspections and audits is highly desirable.

• Strong organizational skills and the ability to maintain accurate and comprehensive records.
• Proficiency with MS Office (Word, Excel, PowerPoint) and other relevant documentation tools.
• Ability to work collaboratively across teams and departments.