Regulated Documentation & Change Control Specialist(Onsite)

Connexion Systems & Engineering Inc.; 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

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.