Document and Change System Specialist

Connexion Systems + Engineering; Vista (CA); On-site; USD 59,000 - 65,000; Full time

Job summary

Connexion Systems & Engineering is seeking a detail‑oriented Document and Change Control Specialist in Vista, CA. You will support QA operations in a regulated manufacturing environment, manage controlled documentation, and handle change requests to ensure FDA/cGMP compliance.

The role requires experience with GMP documentation, electronic document management systems, SOP administration, and cross‑functional collaboration to ensure timely reviews and approvals. Onsite 1st shift business hours.

Qualifications

• 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.

Responsibilities

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

Skills

FDA regulations

cGMP

Document control

Change control

Quality Systems

Electronic document management

Spreadsheets

Databases

Communication

Detail-oriented

Education

Bachelor's degree in a scientific field

Tools

eQMS

SOP administration

Job description

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, 1st 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

• 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.