Quality Specialist

PLZ Corp; Coal City, Northern (IL, KY); On-site; USD 70,000 - 80,000; Full time

Benefits offered by this job

Medical benefits

401(k) with match

Paid time off

Job summary

PLZ Corp is seeking a Quality Specialist to support GMP-compliant quality systems, documentation, audits and training. The role involves investigations of deviations and complaints, CAPA management, and collaboration across functions to strengthen quality controls.

Qualified candidates will have 3–5 years QA in regulated manufacturing, knowledge of FDA regulations and data integrity, plus strong writing and communication skills. On-site role with comprehensive benefits.

Qualifications

• Bachelor's degree in science, engineering or related field.
• Minimum 3–5 years QA in regulated manufacturing (pharma/OTC/cosmetic).
• Experience with deviations, CAPA, investigations and regulatory/customer audits.
• Strong technical writing and organizational skills.

Responsibilities

• Lead investigations for deviations and complaints with root cause analysis.
• Drive CAPA activities for effective corrective actions.
• Support validation activities and data integrity per ALCOA+ and 21 CFR 211.
• Assist audits and prepare responses; back up Quality Manager duties.

Skills

FDA regulations

GMP

ALCOA+ data integrity

Root cause analysis

Regulatory reporting

Technical writing

Multi-priority management

Communication skills

ERP systems (SAP)

Education

Bachelors in science/engineering/related

Tools

ERP (SAP+)

Job description

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. Learn more at www.plzcorp.com/careers or visit https://youtu.be/XYNIFpLQIJY

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.

Key Responsibility:

• 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.

Qualifications:

• 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+).

WORK ENVIRONMENT & PHYSICAL REQUIREMENTS:

• Office/Manufacturing environment

COMPENSATION:

Our compensation reflects the cost of labor across several US geographic markets. The base pay for this position ranges from $70,000in our lowest geographic market up to $80,000. in our highest geographic market. Pay is based on a number of factors including market location and may vary depending on job-related knowledge, skills, and experience. Dependent on the position offered, other forms of compensation may be provided as part of a total compensation package, in addition to a full range of medical, financial, and/or other benefits.

PLZ Corp offers a robust suite of benefits including:

• 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 (Note, bonuses are subject to the rules governing the program, whereby an award, if any, depends on various factors, including, without limitation, individual and organizational performance.)

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability, protected veteran status or other protected status. EEOE/M/F/Vet/Disabled. All your information will be kept confidential according to EEO guidelines.

Equal Opportunity Employer

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.