QA Associate

Bimeda•Pomona, CA

2d•$82,000 - $115,000•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 owns core GMP responsibilities, including product release, change control, Annual Product Reviews (APRs), and deviation and CAPA resolution, while also supporting the adoption of electronic quality systems (e-QMS, LIMS, and electronic batch records), advancing data-driven and risk-based decision-making, and championing a culture of continuous improvement. This is an opportunity for a quality professional who is energized by modernization, comfortable challenging established processes, and ready to help build a leaner, more capable quality organization for the future.

Requirements

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

Nice To Haves

Experience with electronic quality systems (such as ZenQMS, TrackWise, or MasterControl), LIMS, or electronic batch record (EBR) platforms.
Experience using data analytics, trending, dashboards, or AI-assisted quality tools to support risk-based decision-making.
Demonstrated experience supporting or driving process improvement, automation, or digital transformation initiatives in a regulated environment.
A track record as a change agent, someone who has identified and driven improvements to legacy processes rather than simply maintaining them.
ASQ certification (CQA, CQE) or equivalent quality certification is a plus.

Responsibilities

Conduct Annual Product Reviews (APRs) by analyzing production documentation, summarizing key issues and trends, and preparing final reports, incorporating quality metrics and trending data where available.
Perform batch record review and determine batch disposition (release, reject, or hold) based on quality and risk impact; support the shift toward risk-based, exception-driven batch review as electronic batch records (EBR) are implemented.
Provide oversight and QA approval for CAPA, deviation, and change control systems; monitor quality history and trends, and recommend data-driven improvements.
Lead change control initiatives and facilitate documentation workflows in the e-QMS, supporting the site's transition to a fully electronic quality management system.
Administer and maintain GMP documents (Policies, Corporate SOPs) and quality records within ZenQMS, supporting the ongoing digitization and simplification of the site's document library.
Investigate product complaints, deviations, and OOS results to determine root cause, quality impact, and corrective and preventive actions.
Perform internal QA audits on manufacturing lines and finished products to verify compliance with corporate policies and GMP requirements.
Participate in regulatory, customer, and internal/mock audits; ensure timely completion and effectiveness verification of corrective actions.
Support the site's quality initiatives and broader inspection-readiness activities, including SOP framework reapproval and CAPA effectiveness tracking.
Ensure ongoing compliance with local, national, and international cGMP standards and legislation.
Support the implementation and adoption of e-QMS, LIMS, and electronic batch records, helping shift routine administrative work toward risk-based technical review and decision-making.
Use quality metrics, trend analysis, and dashboard or reporting tools, including AI-assisted quality analytics where available, to identify patterns, flag emerging risks, and inform data-driven decisions.
Champion quality culture initiatives such as Gemba walks, Quality Minutes, and Good Quality Catch recognition; support classification and reduction of human-error deviations.
Assist with development, simplification, and continuous improvement of departmental procedures, SOPs, and best practices, with a focus on reducing manual and administrative burden.
Proactively identify opportunities to simplify, automate, or eliminate manual quality processes; act as a change agent who is comfortable challenging legacy ways of working in support of a leaner, more capable quality organization.
Support cross-training and knowledge-sharing efforts to reduce single-point dependencies and build a more flexible, resilient quality team.
Collaborate with client-facing QA representatives and cross-functional partners in Manufacturing, QC, and Regulatory to ensure product and service quality and customer satisfaction.
Provide training and coaching to operators and supervisors on documentation practices, cGMP requirements, and evolving digital quality tools and workflows.
Communicate quality and documentation requirements clearly to internal teams and customers.
Promote quality achievement and continuous improvement across the organization; serve as a visible advocate for quality as a shared value woven into everyday decisions.