Premier Care Industries (PCI) is a contract manufacturer of OTC drug products, cosmetics, and personal care wet wipes, including EPA-registered disinfecting wipes, baby wipes, OTC medicated wipes, and flushable wipes. We manufacture for major national brands and retailers. Position Summary The QA Complaint Specialist owns PCI's customer complaint program day to day. This person is the subject matter expert on complaint handling and the main contact between Quality, Production, R&D, Supply Chain, and customer-facing teams. The Specialist does the investigation work, including gathering evidence, reviewing records, and coordinating with other departments. They then prepare complete investigation packages and customer responses for QA management to review and approve. Key Responsibilities

• Receive, log, and triage customer and consumer complaints in the eQMS (Qualio), classifying them by product type, severity, and potential regulatory impact.
• Conduct or coordinate investigations, including batch record review, retain sample evaluation, equipment and line history review, and interviews with production staff.
• Work with Production, R&D, Supply Chain, and Maintenance to find root cause and collect supporting data.
• Draft investigation reports, root cause analyses, and customer response letters for QA Management review and approval.
• Identify complaints that may need regulatory reporting and escalate them to QA management.

This includes OTC adverse events, cosmetic serious adverse events under MoCRA, and

EPA FIFRA 6

(a)(2) adverse effects.

• Recommend and initiate CAPAs when an investigation supports one, and track CAPAs through to effectiveness checks.
• Keep complaint files complete and audit-ready per 21 CFR 211.198 and applicable customer quality agreements.
• Track complaint timelines and make sure customer response deadlines are met.
• Trend complaint data and prepare monthly and quarterly reports for management review.
• Support customer audits, regulatory inspections, and ISO certification activities related to complaint handling.
• Help write and revise complaint-handling SOPs and work instructions. Qualifications
• Bachelor's degree in a science (Chemistry, Biology, Microbiology, or related field) preferred. Equivalent experience will be considered.
• At least 2 years of complaint handling, investigation, or quality assurance experience in a cGMP-regulated environment, such as OTC drugs, cosmetics, pharmaceuticals, medical devices, or personal care.
• Working knowledge of 21 CFR Parts 210/211, cGMP principles, and complaint and adverse event reporting requirements.
• Familiarity with MoCRA, ISO 22716, ISO 9001, or EPA requirements is a plus.
• Experience with root cause tools such as 5 Whys, fishbone diagrams, and fault tree analysis, and with the CAPA process.
• Experience using an eQMS (Qualio, MasterControl, Veeva, or similar) preferred.
• Strong technical writing skills, with the ability to produce clear, factual, customer-ready documents.
• Able to work across departments and hold others accountable for deadlines without direct authority.
• Organized, detail-oriented, and able to manage multiple open investigations at the same time.
• Proficient in Microsoft Office, especially Excel for trending.
• Bilingual (Spanish and English) a plus but not mandatory PCI is an Equal Opportunity Employer.

Pay:

$60,000.00

• $65,000.

00 per year

Benefits:

401(k) Dental insurance Health insurance Paid time off Vision insurance

Work Location:

In person