Document Control Specialist

Planet Pharma; Newark (CA); On-site; USD 55,000 - 69,000; Full time

Job summary

Planet Pharma in Newark, CA seeks a detail-oriented Document Control Specialist to support controlled-document lifecycles across production, testing, validation, and quality operations within a GMP environment. You will collaborate with cross-functional partners, maintain templates, and ensure timely, accurate documentation.

The role emphasizes strong organizational skills, proficiency with Word/Excel/Acrobat/Visio, and experience with electronic document management systems like Veeva

Qualifications

• High school diploma with at least 5 years of document control experience in GMP-regulated settings.
• Proficient with Word, Excel, Acrobat and Visio; advanced Word features preferred.
• Experience with Veeva QualityDocs or similar EDM systems.
• Strong organizational skills and attention to detail in multi-priority environments.
• Excellent communication and collaboration with internal customers and cross-functional partners.
• Experience maintaining organized documentation and records for retention practices.
• Exposure to validation processes and validated electronic systems is a plus.

Responsibilities

• Provide responsive support to internal customers to promote timely project execution.
• Create and revise procedures and execution documents in line with processes and timelines.
• Process, distribute, and maintain GMP documentation across production, testing, validation, and quality records.
• Perform document control reviews using checklists to verify templates, formatting, and requirements.
• Contribute to continuous improvement of document control tools, checklists, and SOPs.
• Take on additional duties to support Quality team objectives.

Skills

Document control

GMP

MS Word

MS Excel

Adobe Acrobat

Visio

Veeva QualityDocs

Validation

Record retention

Cross-functional collaboration

Education

High School Diploma

Tools

Veeva QualityDocs

Job description

Job Description: We are seeking a detail-oriented and collaborative Document Control Specialist to join our Quality team at our Newark, CA facility. This role offers an opportunity to support critical document control activities within a GMP-regulated environment while contributing to our work in the exciting field of allogeneic CAR T cell therapy. The Document Control Specialist supports controlled-document lifecycle activities used for production, validation, testing, and quality operations. The ideal candidate is a self-directed team member with strong prioritization skills who can work effectively both independently and in a collaborative team environment. This role helps strengthen efficient, compliant documentation practices while delivering accurate, timely results in a fast-paced environment.

Responsibilities

• Provide responsive support to internal customers, promoting 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 standard checklists to verify appropriate templates, formatting, punctuation, and applicable document control requirements.
• Support continuous improvement of document control tools, checklists, and SOPs that define and strengthen standard team processes.
• Perform additional duties and assignments as requested by management to support Quality team objectives.

Requirements

• High school diploma with a minimum of 5 years of document control experience in a GMP-regulated pharmaceutical, biologic, 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.
• 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 partners.
• Experience maintaining organized documentation or records to support record retention practices.
• Exposure to validation processes and documentation, Process Development, and validated electronic computer systems is preferred.

Education

• High school diploma with a minimum of 5 years of document control experience in a GMP-regulated pharmaceutical, biologic, or medical device environment.

Pay Rate Range: $40-50/hr