Technical Documentation Specialist

Responsibilities:

• Organizing an archiving system.

• Labeling, sorting, and categorizing documents for ease of use.

• Retrieving documents upon request.

• Outlining a long-term storage strategy.

• Adhering to regulatory requirements.

• Working with colleagues to ensure consistency of documentation practice across the company.

• Assisting with both internal and external audits.

• Ensuring documentation integrity.

• Controlling access to documents.

• Removing documents that are obsolete.

• Utilizing storage software and applications for electronic filing.

• Performing transcription and conversion work.

• Proofreading documents upon request.

Additional Responsibilities:

• Authoring and editing/revising Validation Documents (Protocols, Reports, etc.) for Validation Activities (EOs, PPQs, etc.).

• Experience in cGMP documentation review required.

• Experience in highly regulated businesses with ANDA and regulatory requirements.

• Facilitating Review & Approval of Validation Documents in formal Document Management Systems.

• Providing on-site support to execute Validation Activities in the packaging operations at the plant.

• Reviewing and providing mark-up/input on Validation Documents authored by others.

Skills and Knowledge Areas:

• GMP (Good Manufacturing Practices) Compliance

• GDP (Good Documentation Practices)

• QMS (Quality Management Systems)

• FDA 21 CFR Part 210, 211, 820 Regulations

• Batch Record Review & Approval

• CAPA (Corrective and Preventive Actions)

• Investigation & Deviation Management

• Change Control Management

• Quality Systems Auditing (Internal/External)

• Pre-Approval Inspection (PAI) Preparedness

• Aseptic Processing & Sterile Drug Products

• Document Control & SOP Review

• Training Program Development & Delivery

• On-the-Job Training (OJT) & Curriculum Development

• Regulatory Compliance & Inspection Readiness

• Data Integrity & LIMS

• Root Cause Analysis & Problem Solving

• Customer Complaint Investigation

• Project Management & Continuous Improvement

• TrackWise, Veeva Vault, Documentum, QUMAS

• MS Visio, MS PowerPoint, Excel, Word, Smartsheet