Quality Specialist

PLZ, Corp • Coal City, IL

5d • Hybrid

About The Position

The Quality Specialist is responsible for supporting quality systems, documentation, audits & training in GMP environment adhering to the ISO and FDA GMP regulations and follows SOPs, GMP, GLP and GDP. Additional responsibilities include serving as backup for the Quality Manager. This role is crucial in maintaining compliance and driving continuous improvement within the organization's quality framework.

Requirements

• 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.
• Bachelor’s degree in science, Engineering, or related field.
• 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.
• Experience using and navigating ERP systems (SAP+).

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.
• Act as backup for the Quality Manager.

Benefits

• Medical, Dental & Vision benefits.
• Company paid Life and Short-Term disability.
• Voluntary benefits including additional life, disability, and hospital/accident insurance.
• 401k & company provided match.
• Paid Time Off
• Bonus incentive programs

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level