Quality Assurance Leader — Regulated Manufacturing

HR-Consulting-Solutions-LLC

Hickory (NC)

On-site

USD 110,000 - 140,000

Full time

8 days ago

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Benefits offered by this job

Competitive compensation

Comprehensive benefits package

Paid vacation and holidays

401(k) retirement with company match

Job summary

Premier Candle, a leading candle and home fragrance manufacturer, is seeking an experienced Quality Assurance Manager to lead the Quality Department and ensure products meet customer specifications and regulatory requirements. You will oversee the QMS, data analysis, audits, and continuous improvement initiatives in a fast-paced manufacturing environment.

Reporting to the VP of Operations, you will develop personnel, partner with Operations, support customer and regulatory audits, and drive CAPA

Qualifications

Bachelor’s degree in Science, Engineering, Chemistry, Life Sciences, or another appropriate field.
5+ years of experience in a quality, analytical, microbiological, or life science role within a manufacturing environment.
Demonstrated knowledge of quality assurance and quality control principles within a manufacturing environment.
Experience with FDA, EPA, and/or other applicable regulatory requirements.
Working knowledge of cGMP, GLP, Good Documentation Practices, quality systems, and regulated manufacturing processes.
Experience with quality investigations, root cause analysis, corrective actions, and continuous improvement.
Experience developing, reviewing, and maintaining quality documentation, including SOPs and Work Instructions.
Strong analytical and problem-solving skills with the ability to interpret data, identify trends, and implement effective corrective actions.
Demonstrated ability to work independently and effectively manage personnel, priorities, projects, and resources with minimal supervision.
Strong leadership, organizational, decision-making, and communication skills.
Proficiency with Microsoft Office applications, including Excel and Word.

Responsibilities

Manage and continuously improve the Quality Management System (QMS) to ensure products consistently meet customer expectations, company standards, and applicable regulatory requirements.
Ensure compliance for regulated products by following established test methods and procedures related to FDA, EPA, and micro-susceptible product and process requirements.
Manage and direct quality functions in accordance with established protocols, cGMP, Good Laboratory Practices (GLP), Good Documentation Practices, and applicable safety requirements.
Develop and maintain processes for inspecting and evaluating product quality against company standards and customer specifications.
Review analytical and testing data and authorize the release of Raw Material (RM) lots, Bulk Formula (BF) batches, and Finished Goods (FG) lots.
Ensure quality processes, testing methods, documentation, and controls are consistently and accurately executed throughout the organization.
Lead and approve Out-of-Specification (OOS) investigations.
Serve as a Lead or Associate Investigator and provide analytical, inspection, and technical support for OOS, Deviation, and CAPA investigations.
Utilize advanced problem-solving and root cause analysis skills to investigate quality issues, identify effective solutions, and implement corrective action plans.
Drive continuous improvement initiatives focused on preventing defects, improving processes, reducing waste, increasing efficiency, and lowering costs.
Identify recurring quality concerns and work cross-functionally to implement sustainable corrective and preventive measures.
Develop and execute quality assurance protocols that provide clear guidance and support to employees and project teams.