Change Control & Document Management Specialist

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

Compensation, Benefits, and Employment Type

• Duration: 6+ months contract, possible extension or conversion
• Pay rate: $37 - $43/hr
• Job Location: Los Angeles, CA
• Schedule: M-F, 1^st shift, 8am – 4:30pm
• Job#: bh18853

Description:
This role is responsible for workflow management, review of change control documentation, and oversight of document activities within the document management system. The position supports production operations by issuing work/support orders, tracking tasks within the electronic Quality Management System (eQMS), and coordinating follow-ups to ensure timely completion of activities.Key Responsibilities

• Manage workflow and review of change control records within the electronic Quality Management System (eQMS), including Veeva
• Review change control documentation for accuracy, completeness, and compliance with cGMP standards and internal requirements
• Track and report on the status of open change control records; generate routine status reports
• Follow up on open items and drive timely closure of change control activities
• Issue tag-outs for equipment and facilities as required by change control processes
• Support Key Performance Indicator (KPI) reporting by generating relevant data and metrics
• Coordinate and follow up on change control requirements for shutdown projects, including authorization of production areas and product release
• Process and maintain documents within the Document Management System, including workflows for review, approval, issuance, and effectiveness
• Assist with projects related to document management systems and change control improvements
• Utilize tools such as Microsoft Excel, Access, and eQMS for tracking, trending, and data entry
• Communicate cross-functionally to ensure alignment and provide strong internal customer support

Qualifications & Requirements

• Bachelor’s degree with a minimum of 2 years of relevant experience, OR advanced degree with no experience, OR equivalent combination of education and experience
• Prior experience in a cGMP-regulated industry preferred
• Experience working with eQMS (e.g., Veeva) strongly preferred

Skills & Competencies

• Strong attention to detail with the ability to maintain accurate and complete records
• Highly organized with the ability to manage multiple priorities in a fast-paced environment
• Proactive, self-motivated, and able to work independently or as part of a team
• Strong analytical, troubleshooting, and problem-solving skills
• Ability to make structured, data-driven decisions
• Excellent verbal and written communication skills
• Strong interpersonal skills with the ability to interact effectively across all levels of the organization
• Proficiency in Microsoft Office (Outlook, Word, Excel, Access)

Please use the apply button to submit your resume for consideration.  A Connexion Representative will contact you shortly.

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