Document Control Specialist; Biotech​/Pharma)

Schedule: 1st Shift | Hybrid - 3-4 days onsite

Pay Rate: $40-48/hr

Duration: 1-Year Contract

Start Date: ASAP

We are seeking a detail-oriented and collaborative Document Control Specialist to join a Quality team in a GMP-regulated biotechnology environment. This position will support critical document control activities related to production, validation, testing, and quality operations within an innovative cell therapy organization.

The ideal candidate is highly organized, self-directed, and comfortable managing multiple priorities while maintaining accuracy and compliance in a fast-paced environment.

• Provide responsive support to internal customers to help ensure timely project execution and a positive customer experience.
• Partner with internal customers to create and revise procedures and execution documents in alignment with established processes and timelines.
• Process, distribute, and maintain GMP documentation, including production, testing, validation, and quality records.
• Perform document control reviews using established checklists to verify templates, formatting, punctuation, and applicable document control requirements.
• Support continuous improvement of document control tools, checklists, and SOPs.
• Maintain accurate and organized documentation and records in accordance with record retention practices.
• Support Quality team objectives through additional assignments and projects as needed.

• High school diploma with a minimum of 5 years of document control experience in a GMP-regulated pharmaceutical, biologic, biotechnology, or medical device environment.
• Strong computer skills, including proficiency with Microsoft Word, Excel, Adobe Acrobat, and Visio
  .
• Advanced Microsoft Word functionality is preferred.
• Experience using Veeva Quality Docs or a comparable electronic document management system (EDMS).
• Strong organizational skills and attention to detail, with the ability to manage multiple priorities accurately and efficiently.
• Excellent interpersonal and communication skills with the ability to collaborate effectively with internal customers and cross-functional teams.
• Experience maintaining organized documentation and records to support record retention requirements.
• Exposure to validation processes and documentation, Process Development, and validated electronic/computerized systems is preferred.

• Join a Quality team within a cutting-edge biotechnology environment.
• Gain experience supporting GMP documentation across production, validation, testing, and quality operations.
• Work in the innovative field of cell therapy.
• Hybrid schedule with 3-4 days onsite.
• Opportunity to contribute to process improvements and cross-functional projects.

Training: Training will be provided during the first few weeks to month, depending on experience.