Quality Assurance Supervisor (Pharmaceutical Packaging) - Onsite in Windsor, NJ

The International Society for Pharmaceutical Engineering, Inc.; Windsor; On-site; CAD 70,000 - 95,000; Full time

Job summary

A leading company in pharmaceutical packaging is looking for a Quality Assurance Supervisor in Windsor, Canada. This role involves enhancing quality management systems, leading quality initiatives, and ensuring compliance with industry standards. The successful candidate will have substantial experience in quality management, particularly within the pharmaceutical sector, and will play a crucial role in maintaining high-quality standards and operational efficiency.

Qualifications

• Minimum 2 years in quality management in printing, packaging, or pharmaceutical industries.
• Expertise in ISO 9001 and ISO 15378 standards required.
• Lean Six Sigma certification is a plus.

Responsibilities

• Develop and manage the Quality Management System (QMS) at the facility.
• Facilitate quality improvement initiatives and lead audits.
• Supervise the Quality Department and train employees on quality standards.

Skills

Analytical Skills

Communication

Leadership

Continuous Improvement

Education

Bachelor's degree in Quality Management, Engineering, Business Administration

Tools

Quality Management Systems

Data Analysis Tools

QCBD Software

Job description

Quality Assurance Supervisor - Pharmaceutical Packaging

Overview :

Our client leads the way in providing innovative packaging solutions to the Healthcare market. Our client provides a one-stop shop for all pharmaceutical packaging needs including labels, folding cartons and boxes, inserts, outserts, IFUs and DFUs, Med Guides, and physician support literature. Their industry-best lead times are made possible by their coast-to-coast manufacturing footprint and their dedicated team of packaging specialists with a passion for quality and service. They are currently seeking a highly motivated and experienced Quality Assurance Supervisor to lead their commitment to quality, operational efficiency, and excellence at in Windsor, NJ. As the QA Supervisor, you will be responsible for developing, implementing, and maintaining a comprehensive Quality Management System and will play a key role in fostering a culture of quality, efficiency, and continuous improvement at the facility.

Responsibilities :

• Develop, implement, and manage the site Quality Management System (QMS) that aligns 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 that our 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 adheres to local regulations and industry standards for pharmaceutical packaging and printing.
• Ensure timely and accurate reporting of safety concerns, incidents, and near misses.
• Oversee housekeeping walkthroughs and address all safety issues with Plant Management.
• Conduct monthly trainings and safety meetings to reinforce safe work practices and company policies.
• Oversee monthly 5S projects to improve workplace organization, cleanliness, and efficiency. Work with teams to ensure compliance with 5S principles.
• 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 plant Management in driving a culture of quality excellence, continuous improvement, and accountability.
• This role will have supervisory responsibilities over the Quality Department, and it is expected that this individual will have previous experience leading successful teams.
• Other duties as assigned.

Qualifications :

• Bachelor's degree in a related field (e.g., Quality Management, Engineering, Business Administration) is preferred.
• Minimum of 2 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 15378 (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

Additional Notes :

• Hands-on working experience with QA techs on the floor and having a regular presence
• 4 direct reports at full capacity. 2 currently with 1 temp to perm and 1 open role
• 60 total employees sit at the site
• Product is held at a nearby facility and may go there on occasion to review the product

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Quality Assurance Supervisor • Windsor, Windsor, Canada