Quality Specialist, Personal Care

About the role

PLZ is committed to product stewardship and innovation, strong ethical standards, sustainable operations, and the development of our people. The Quality Specialist supports quality systems, documentation, audits, and training in a GMP environment, adhering to ISO and FDA GMP regulations, and follows SOPs, GMP, GLP, and GDP. This role also serves as a backup for the Quality Manager.

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 Subject Matter Expert (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.

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 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.
• Strong communication and public speaking skills.
• Experience using and navigating ERP systems (SAP+).

Work Environment & Physical Requirements

Office/Manufacturing environment.

Pay

The base pay for this position ranges from $70,000 in our lowest geographic market up to $80,000 in our highest geographic market. Pay is based on market location and may vary depending on job-related knowledge, skills, and experience.

Benefits

• Medical, Dental, and Vision benefits.
• Company-paid Life and Short-Term Disability insurance.
• Voluntary benefits including additional life, disability, and hospital/accident insurance.
• 401k with company-provided match.
• Paid Time Off.
• Bonus incentive programs (Note: bonuses are subject to program rules, where awards depend on individual and organizational performance).