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Quality Assurance Manager

2 months ago

Garner, North Carolina, United States RLG Healthcare Full time
Quality Assurance Manager

Rewarding a career in quality assurance with RLG Healthcare, a leading provider of innovative packaging solutions to the pharmaceutical industry. As a Quality Assurance Manager, you will play a pivotal role in ensuring the highest standards of quality, operational efficiency, and excellence at our facility in Garner, NC.

Key Responsibilities:
  • Develop and implement a comprehensive Quality Management System (QMS) aligned with industry standards and organizational objectives.
  • Facilitate quality and continuous improvement initiatives to enhance operational efficiency, customer satisfaction, and overall performance.
  • Lead all quality efforts at the plant to ensure products consistently meet or exceed defined quality standards and customer expectations.
  • Collaborate with cross-functional teams to identify and implement quality improvements, drive process optimization, and achieve cost-effectiveness.
  • Ensure timely resolution and closure of Corrective and Preventive Action (CAPA) plans.
  • Conduct regular audits and assessments to evaluate the effectiveness of the QMS and processes, identifying areas for improvement.
  • Analyze quality performance data and metrics to identify trends, develop insights, and drive data-driven decision-making.
  • Establish and monitor key performance indicators (KPIs) to track the effectiveness and efficiency of quality processes and continuous improvement initiatives.
  • Ensure site adherence to local regulations and industry standards for pharmaceutical packaging and printing.
  • Provide training and mentorship to employees to enhance their understanding of quality principles, practices, and methodologies.
  • Oversee supplier quality management, including supplier evaluations and audits, to ensure the quality of incoming materials and components.
  • Represent the facility in dealings with external stakeholders related to quality and continuous improvement.
  • Assist the General Manager in driving a culture of quality excellence, continuous improvement, and accountability.
Requirements:
  • Bachelor's degree in a related field (e.g., Quality Management, Engineering, Business Administration) is preferred.
  • Minimum of 5 years of experience in quality management within the printing, packaging or pharmaceutical industries, with a proven track record of improving quality standards and processes.
  • Expertise in ISO 9001 (Quality Management Systems) and ISO Primary Packaging Materials for Medicinal Products) standards
  • Expertise with FSC, SFI and PEFC environmental certifications and system maintenance
  • Prior experience managing direct reports and leading teams to drive quality improvements and standardization efforts.
  • Understanding of pharmaceutical industry regulations, including cGMP, FDA, and international quality standards.
  • Strong analytical skills with the ability to analyze data, identify trends, and implement effective solutions.
  • Excellent communication and interpersonal skills to lead and collaborate with cross-functional teams, direct reports, and stakeholders.
  • Proficiency in quality management systems, data analysis tools, and software applications.
  • QCBD Software Experience is a plus
  • Relevant certifications such as Certified Quality Manager (CQM) or Certified Quality Auditor (CQA) are advantageous.
  • Lean Six Sigma certification is a plus