Document and Change System Specialist

The ideal candidate will have experience with GMP documentation, electronic document management systems, SOP administration, and change control processes within the pharmaceutical, biotechnology, or other FDA-regulated industries. You'll collaborate with cross-functional teams to maintain documentation integrity, support regulatory compliance, and ensure effective change control processes.

Title: Document and Change Control Specialist
Hiring Organization: Connexion Systems & Engineering

Compensation, Benefits, and Employment Type

• Duration: 3+ months, possible extension
• Pay rate: $43-$47/hr
• Job Location: Vista, CA
• Work Model: 100% onsite
• Schedule: Monday – Friday, 1^st shift
• Job#: bh19703

Description:
We are seeking a detail-oriented Document and Change Control Specialist to support Quality Assurance operations within a regulated manufacturing environment. This individual will manage controlled documentation, process change requests, and ensure compliance with FDA regulations, current Good Manufacturing Practices (cGMP), and internal quality standards.

The ideal candidate will have experience with GMP documentation, electronic document management systems, SOP administration, and change control processes within the pharmaceutical, biotechnology, or other FDA-regulated industries.

Key Responsibilities

• Process and manage change control requests related to manufacturing processes, equipment, facilities, suppliers, and procedures.
• Maintain and track change requests throughout their lifecycle, ensuring timely review, approval, and implementation.
• Manage controlled documentation, including SOPs, forms, job aids, and training materials.
• Maintain electronic document control systems and ensure accurate document versioning, approvals, distribution, and archival.
• Review documentation for accuracy, completeness, formatting, and regulatory compliance.
• Collaborate with cross-functional teams to coordinate change reviews, impact assessments, and required approvals.
• Ensure compliance with FDA regulations, cGMP requirements, and internal quality procedures.
• Maintain document control databases, tracking systems, and records.
• Support continuous improvement of document and change control processes.

Qualifications
Required:

• Bachelor's degree in a scientific field.
• Strong understanding of FDA regulations and cGMP requirements.
• Experience with document control, change control, or Quality Systems in a regulated environment.
• Proficiency with electronic document management systems, spreadsheets, and databases.
• Excellent organizational, analytical, and communication skills.
• Strong attention to detail and ability to manage multiple priorities independently.

Preferred:

• Experience in pharmaceutical, biotechnology, plasma, or other FDA-regulated manufacturing environments.
• Familiarity with electronic Quality Management Systems (eQMS) and document control platforms.
• Experience managing SOP lifecycles, change requests, and quality documentation.

Why Apply?
This is an opportunity to contribute to critical Quality Assurance operations within a highly regulated manufacturing environment. You'll collaborate with cross-functional teams to maintain documentation integrity, support regulatory compliance, and ensure effective change control processes.

Interested? Apply today to learn more about this contract opportunity in Vista, CA.

Please use the apply button to submit your resume for consideration. You will receive a brief survey via email to complete your application. Applicants who complete the survey will receive priority consideration.

You can review our other job postings athttps://jobs.csetalent.com/.

If you are active in a job search but this job is not for you, please reach out to 

jobpostings@csetalent.com

. We would be glad to help you find the perfect job!

Connexion’s mission is to provide "best in class" services to job seekers. We strive to achieve excellence in job placement, staffing, and recruiting services, while treating candidates with the professionalism and respect they deserve.