Quality Specialist

PLZ Corp • Coal City, IL

5d • $70,000 - $80,000 • Onsite

About The Position

PLZ is committed to product stewardship and innovation, strong ethical standards, sustainable operations and most importantly, the development of our people. Whether at our manufacturing facilities or corporate headquarters, PLZ prioritizes health and safety, and offers you the support you need to create the career you want, through engagement, equity and inclusion, and opportunity. From household cleaning solutions to personal care products, and food to automotive lubricants, PLZ produces more than 2,500 different aerosol and liquid products in our facilities across the continent. We know that being the partner of choice for our clients starts with being the partner of choice for our employees. 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 as Quality Manager back up.

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.

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