Quality Administrative Assistant

Job Title:

Administrative Support Specialist

Job Description

The Administrative Support Specialist maintains and supports the quality system documentation for a regulated manufacturing environment, with a focus on document control, change control, and administrative support for quality operations. This role manages documents throughout their lifecycle, sustains the change control process in the internal ERP system, and ensures that all documentation meets regulatory, quality, and internal standards.

Responsibilities

+ Maintain the quality system documentation, including procedures for document creation, review, approval, and archiving.

+ Track and control documents throughout their lifecycle, ensuring proper versioning, access control, and security.

+ Ensure all documents adhere to regulatory requirements, quality standards, and internal procedures.

+ Scan, organize, and maintain both physical and digital documents, including archiving historical records.

+ Manage user access, permissions, and system integrity within the internal ERP change control system.

+ Schedule weekly and emergency Change Control Board (CCB) meetings as requested by internal departments.

+ Review documents for formatting, compliance, and version control standards.

+ Collaborate with cross-functional teams to facilitate document workflows, resolve documentation issues, and ensure consistency in documentation practices.

+ Maintain record retention timelines and ensure documentation is accessible in a timely manner for internal and external audits.

+ Process approved change controls in a timely manner, including updating information in the internal ERP systems.

+ Maintain the internal viewing system by adding current versions of controlled documents and removing historical revisions.

+ Provide administrative support to the quality function, focusing on documentation and clerical tasks in a regulated manufacturing environment.

Essential Skills

+ Approximately 2 years of experience in an administrative support role for quality or in a document control role, with a strong administration focus.

+ Experience providing administrative support in a manufacturing setting.

+ Understanding of Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP).

+

Experience with an electronic document management system.

+ Proficiency with Microsoft Office, including Excel.

+ Experience working in a regulated manufacturing environment, ideally in medical device or aerospace.

+ Ability to manage document version control, access permissions, and record retention.

+ Strong organizational skills with the ability to scan, organize, and maintain physical and digital records.

+ Attention to detail and accuracy in reviewing and formatting documentation.

+ Ability to collaborate effectively with cross-functional teams and support document workflows.

Additional

Skills & Qualifications

+ Open to recent graduates with some administrative experience in a manufacturing setting.

+ ERP system knowledge is ideal, particularly in relation to change control processes.

+ Experience supporting quality administration or quality control functions.

+ Experience in clerical and administrative support roles.

+ Familiarity with document control in a medical device or other regulated industry.

+ Comfort working in a smaller organization where responsibilities may be broad and hands-on.

Work Environment

This role is based 100% onsite at a smaller, single-location manufacturing facility that specializes in medical devices, including hyperbaric oxygen therapy equipment and respiratory products. The site has approximately 70 employees onsite, with the majority working on the production floor, and a small sales team operating across the United States. The Administrative Support Specialist joins a small quality-focused team, working closely with a manager and one other team member who concentrates on core quality activities, while this role focuses on the administrative and documentation aspects.

The environment is regulated, with significant documentation and paperwork associated with each product manufactured. The position follows a standard daytime schedule, with working hours from 8:00 a.m. to 4:30 p.m., offering a stable setting within a long-standing company that has a strong foothold in its specialized segment of the medical device industry.

Job Type & Location

This is a Contract to Hire position based out of Anaheim, CA.

Pay and Benefits

The pay range for this position is $22.00 - $25.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:  - Medical, dental & vision
- Critical Illness, Accident, and Hospital  - 401(k) Retirement Plan
- Pre-tax and Roth post-tax contributions available
- Life Insurance (Voluntary Life & AD&D for the employee and dependents)  -…