Quality Assurance Associate

Bimeda•Pomona, CA

3d•Onsite

About The Position

Reporting to the QA Manager, the QA Associate works within an established culture of QA and continuous improvement in all GMP areas. The role is responsible for product release, change control, Annual Product Reviews (APRs), deviation resolution, and ensuring GMP standards are met. Responsibilities include document control activities and coaching operators and supervisors on proper documentation practices. The QA Associate also supports audits, manages QA systems, and ensures timely corrective actions.

Requirements

University degree in a related science field with specific Quality Assurance education or training.
Minimum 2–3 years of experience in pharmaceutical QA systems, document control, and GMP compliance.
Knowledge of pharmaceutical QA methodologies, cGMP regulations, and quality systems.
Proficiency in Microsoft Office and document management systems.
Strong attention to detail, organizational skills, and ability to manage timelines and priorities.

Responsibilities

Conduct annual product reviews by analyzing production documentation, summarizing key issues, and preparing final reports.
Perform batch record review and determine batch status (release, reject, or hold) based on quality impact.
Provide oversight and QA approval for CAPA, deviation, and change control systems; monitor quality history and recommend improvements.
Investigate product complaints, deviations, and OOS results to determine impact, root cause, and corrective actions.
Lead change control initiatives and facilitate documentation updates using Microsoft Word and ZenQMS software.
Perform internal QA audits on manufacturing lines and finished products to ensure compliance with corporate policies and GMP requirements.
Collaborate with client-facing QA representatives to ensure customer satisfaction with products and services.
Support preparation of master documents and coordinate documentation services across departments.
Assist with development and implementation of departmental procedures and best practices.
Administer and manage GMP documents including Policies and Corporate SOPs.
Maintain accurate and current Quality records; ensure proper filing and retrieval of controlled documents.
Perform QA document control functions, including document login, processing, verifying, distributing, reconciling, filing, scanning, and archiving.
Communicate applicable quality or document requirements to internal teams and customers.
Promote quality achievement and continuous improvement across the organization.
Participate in FDA, and customer audits; ensure timely completion of corrective actions.
Ensure ongoing compliance with local, national, and international standards and legislation.
Provide training and coaching to operators and supervisors on documentation practices and cGMP requirements.