Document Control Specialist (Biotech/Pharma)

WaveCrest Staffing Group; Newark (CA); Hybrid; USD 55,000 - 66,000; Full time

Job summary

WaveCrest Staffing Group is seeking a detail-oriented Document Control Specialist to join a GMP-regulated biotechnology Quality team. The role centers on managing production, validation, testing, and quality records in a fast-paced cell therapy environment.

The ideal candidate will be highly organized, self-directed, and able to handle multiple priorities with accuracy while ensuring compliance and timely deliverables. The position offers a hybrid schedule with 3–4 days on site.

Qualifications

• High school diploma and 5+ years of document control in a GMP-regulated setting.
• Proficient with Word, Excel, Adobe Acrobat, Visio.
• Experience with EDMS such as Veeva QualityDocs.
• Strong organizational skills and attention to detail.

Responsibilities

• 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.

Skills

Document control

Attention to detail

Communication

Cross-functional collaboration

Education

High school diploma

Tools

Microsoft Word

Microsoft Excel

Adobe Acrobat

Visio

Veeva QualityDocs

Job description

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

Pay Rate: $40-48/hr

Duration: 1-Year Contract

Start Date: ASAP

Position Overview

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.

Responsibilities

• 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.

Requirements

• 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 QualityDocs 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.

Why Consider This Opportunity?

• 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.