Specialist I, QA
$32 - $37 per hourPLZ Aeroscience Corp
Essential Duties and Responsibilities
This employer is required to notify all applicants of their rights pursuant to federal employment laws.
For further information, please review the Know Your Rights notice from the Department of Labor.
- 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.
- 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.
- 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+).
This employer is required to notify all applicants of their rights pursuant to federal employment laws.
For further information, please review the Know Your Rights notice from the Department of Labor.
Vacancy posted 1 day ago
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