More jobs:
Specialist , QA
Job in
Riverside, Riverside County, California, 92501, USA
Listed on 2026-06-02
Listing for:
PLZ Aeroscience Corporation
Full Time
position Listed on 2026-06-02
Job specializations:
-
Quality Assurance - QA/QC
Data Analyst
Job Description & How to Apply Below
Essential Duties and Responsibilities
* Lead and manage investigations for deviations, non-conformances, and customer complaints, including root cause analysis, product impact assessment, and timely closure.
* Drive and monitor CAPA activities to ensure effective, compliant, and sustainable corrective actions.
* Support validation activities and maintain compliance with cGMP (21 CFR 211) and ALCOA+ data integrity standards.
* Support change control, SOP development, and batch record review to ensure accuracy and regulatory compliance.
* Serve as SME during internal, customer, ISO, and FDA audits, including preparation and response support.
* Perform risk assessments and trend analysis (including complaints) and collaborate cross-functionally to strengthen quality systems and drive continuous improvement.
Knowledge, skills, and abilities
* Strong knowledge of FDA regulations (21 CFR 210/211) and GMP.
* Experience with validation principles and data integrity (ALCOA+).
* Strong investigation and root cause analysis skills.
* Experience handling customer complaints and regulatory reporting expectations.
* Excellent technical writing skills and organizational skills.
* Ability to manage multiple priorities.
* Strong communication and teamwork skills.
* Pay range $32.00 - $37.00 per hour.
Education and/or Experience
* Bachelor's degree in Science, Engineering, or related field (preferred).
* Minimum 3-5 years of experience in Quality Assurance within a pharmaceutical, OTC, cosmetic, or regulated manufacturing environment.
* Experience with deviations, CAPA, investigations, validation (IQ/OQ/PQ, cleaning), and regulatory/customer audits.
* Computer literate, with proficiency in Microsoft Word, Excel, PowerPoint, and Adobe Acrobat.
* Experience supporting audits, customer visits, customer meetings, and classroom training experience.
* Strong communication and public speaking skills.
* Bilingual (English/Spanish) is a plus.
* Experience using and navigating ERP systems (SAP+).
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