Quality Assurance Associate

Northridge, CA - USA

Monthly Salary: Not Disclosed

Posted on: 10-09-2025

Vacancies: 1 Vacancy

Job Summary

Job Description:
This position will provide support to ensure the organization maintains compliance with Quality Systems current Good Manufacturing Practices (cGMPs) current Good Tissue Practices (cGTPs) and in adherence with all applicable Federal State local international and industry regulations and standards. This individual will perform a variety of activities needed to establish and maintain compliance; including responsibilities associated with the quality assurance tasks.
Responsibilities:

Perform job functions in compliance with internal Standard Operating Procedures Current Good Manufacturing and Tissues Practices all Federal and State regulations and accrediting agency standards.
Assist in the management of the electronic document management systems including management of the site training records.
Review batch records and release products.
Assist with the initiation and risk classification of deviations.
Inspect and release incoming materials.
Ensure the electronic copies of SOPs training materials validation plans and other regulated documents are maintained.
Assist in the management of the library of printed documents manuals and reference materials.
Work with departments to coordinate schedule and prepare for document release and training activities for new or revised procedures competency assessments annual GMP training and all other document release and training items as deemed necessary.
Assist in the creation of SOPs forms documents and training materials.
Assist in the creation revision and approval (for minor changes) of SOPs policies forms etc.
Participate in customer and regulatory audits.
Assist the QA/RA department with process improvement activities.
Assist with special projects as assigned.
Perform all other duties at the discretion of management as assigned.
Resolves conflicts with team members and involves functional management as required.

Requirements:

Discretion in handling confidential and sensitive matters.
GMP manufacturing experience.
Strong leadership skills with demonstrated ability to collaborate effectively across teams and functions.
Strong verbal and written communication skills.
Strategic thinking and excellent analytical skills.
Excellent organizational time management and problem-solving skills.
Ability to work well under deadlines and pressure.
Knowledge and proficiency in navigating the electronic document control system.
Bachelors degree in biology or related field.
2 years experience in Quality Assurance role in a regulated environment; cGMP and cGLP Clean Room experience preferred.
Proficient use of Microsoft Office products including Word Excel Outlook and PowerPoint.
Ability to quickly learn new software programs as needed.

Job Description: This position will provide support to ensure the organization maintains compliance with Quality Systems current Good Manufacturing Practices (cGMPs) current Good Tissue Practices (cGTPs) and in adherence with all applicable Federal State local international and industry regulations ...

Perform job functions in compliance with internal Standard Operating Procedures Current Good Manufacturing and Tissues Practices all Federal and State regulations and accrediting agency standards.
Assist in the management of the electronic document management systems including management of the site training records.
Review batch records and release products.
Assist with the initiation and risk classification of deviations.
Inspect and release incoming materials.
Ensure the electronic copies of SOPs training materials validation plans and other regulated documents are maintained.
Assist in the management of the library of printed documents manuals and reference materials.
Work with departments to coordinate schedule and prepare for document release and training activities for new or revised procedures competency assessments annual GMP training and all other document release and training items as deemed necessary.
Assist in the creation of SOPs forms documents and training materials.
Assist in the creation revision and approval (for minor changes) of SOPs policies forms etc.
Participate in customer and regulatory audits.
Assist the QA/RA department with process improvement activities.
Assist with special projects as assigned.
Perform all other duties at the discretion of management as assigned.
Resolves conflicts with team members and involves functional management as required.

Requirements:

Discretion in handling confidential and sensitive matters.
GMP manufacturing experience.
Strong leadership skills with demonstrated ability to collaborate effectively across teams and functions.
Strong verbal and written communication skills.
Strategic thinking and excellent analytical skills.
Excellent organizational time management and problem-solving skills.
Ability to work well under deadlines and pressure.
Knowledge and proficiency in navigating the electronic document control system.
Bachelors degree in biology or related field.
2 years experience in Quality Assurance role in a regulated environment; cGMP and cGLP Clean Room experience preferred.
Proficient use of Microsoft Office products including Word Excel Outlook and PowerPoint.
Ability to quickly learn new software programs as needed.