What are the responsibilities and job description for the Quality Supervisor position at Spherical Search?

Spherical Search is currently working with an industry leading manufacturer of blister packaging for the pharmaceutical industry, focusing mainly on oral solid dosage.

We are currently working together on finding a Quality Supervisor for their site in New Castle, Delaware.

The Quality Supervisor is responsible for overseeing and ensuring compliance with GMP, FDA, ISO, and company quality standards within a pharmaceutical blister packaging environment. This role involves leading quality control (QC) and quality assurance (QA) activities , managing inspections, ensuring product integrity, and collaborating with production teams to maintain high standards of packaging quality.

Key Accountabilities

Leadership and Team Management

Supervisory Skills : Ability to lead, mentor, and guide a team of technicians and analysts, ensuring they follow proper testing protocols and maintain high standards of quality.
Training and Development : Proficiency in training team members on quality standards, testing methods, equipment usage, and compliance with regulatory requirements.
Performance Monitoring : Capability to assess team performance, provide constructive feedback, and set goals for continuous improvement in quality testing.
Conflict Resolution : Ability to manage conflicts within the team or with other departments, ensuring a collaborative work environment.

Quality Control and Assurance Expertise

Testing Methodologies : Strong knowledge of testing methodologies for raw materials, in-process materials, and finished goods, such as physical, chemical, microbiological, and stability testing.

Standard Operating Procedures (SOPs) : Familiarity with developing and ensuring adherence to SOPs for various testing processes and ensuring accuracy and reliability of test results.

Compliance with Regulations : Understanding of industry standards (e.g., GMP, ISO 9001, FDA, or ICH guidelines) for quality control and product testing in regulated industries.

Inspection Techniques : Proficiency in visual inspection, sampling, and using testing equipment to detect defects or deviations in materials and products.

Analytical and Problem-Solving Skills

Root Cause Analysis : Ability to lead investigations into product failures or non-conformances and conduct thorough root cause analysis to prevent future occurrences.

Corrective and Preventive Actions (CAPA) : Experience in implementing CAPA systems to address quality issues, ensuring compliance and continuous process improvement.

Statistical Process Control (SPC) : Knowledge of SPC tools for monitoring quality trends, interpreting data, and ensuring consistency in production processes.

Technical Proficiency in Testing Equipment and Software

Laboratory Equipment : Familiarity with a wide range of testing instruments used for raw materials, in-process, and final product testing (e.g., HPLC, GC, spectrophotometers, pH meters, etc.).

Data Analysis and Reporting Tools : Proficiency with software tools for data analysis (e.g., Excel, Minitab, or LIMS systems) to analyze test results and generate accurate reports.

Troubleshooting : Ability to troubleshoot and calibrate testing equipment and systems to maintain accurate and reliable test results.

Communication Skills

Customer Communication : Strong verbal and written communication skills to manage customer inquiries, complaints, and quality concerns, ensuring prompt and professional responses.

Cross-Department Collaboration : Ability to effectively communicate with other departments (e.g., production, R&D, procurement) to resolve quality issues and streamline processes.

Report Writing : Ability to write clear and comprehensive reports regarding testing outcomes, non-conformances, quality trends, and customer feedback.

Presentation Skills : Capable of presenting findings to senior management, stakeholders, or clients, often involving technical data in a clear and understandable way.

Regulatory Knowledge and Documentation

Documentation Compliance : Expertise in maintaining accurate and compliant records for all quality testing activities, including test reports, batch records, and deviations, in accordance with regulatory requirements.

Audit Readiness : Ability to prepare for and assist with internal and external audits, ensuring all documentation and processes meet industry standards and regulations.

Regulatory Standards Knowledge : Familiarity with regulations such as GMP (Good Manufacturing Practices), GLP (Good Laboratory Practices), FDA, ISO, and other relevant regulatory bodies.

Process Improvement and Continuous Quality Management

Continuous Improvement (CI) : Ability to drive continuous improvement initiatives to optimize testing processes, reduce waste, improve turnaround time, and enhance overall product quality.

Lean Six Sigma or Kaizen Methodologies : Familiarity with methodologies that support process optimization and efficiency, such as Lean, Six Sigma, or Kaizen.

Quality Metrics : Proficiency in defining and tracking key quality metrics (e.g., defect rates, test accuracy, customer complaints) to drive improvements in testing processes.

Risk Management and Decision-Making

Risk Assessment : Ability to evaluate and mitigate risks associated with quality control processes, ensuring that critical deviations or failures are addressed promptly.

Decision-Making : Strong decision-making skills in high-pressure situations to ensure timely resolution of quality issues without compromising product safety and compliance.

Customer-Focused Mindset

Customer Complaint Management : Experience in handling customer complaints related to quality, analyzing root causes, and working to resolve them effectively while maintaining customer satisfaction.

Quality Service Orientation : Ability to prioritize quality standards and maintain strong customer relationships, ensuring that their needs and expectations are met consistently.

Attention to Detail and Organizational Skills

Accuracy in Testing : Attention to detail to ensure all tests are carried out accurately, with results documented properly and in compliance with all relevant standards.

Task Prioritization : Organizational skills to manage multiple tasks, prioritize based on urgency, and ensure smooth operations across various quality control functions.

Qualifications / Competencies

Bachelor's degree in Packaging Science, Chemistry, or a related field; Master's degree preferred.

Minimum of 5 years in quality engineering or polymer science, specifically with a focus on packaging materials in the pharmaceutical industry. Blister packing machines knowledge is a bonus.

Strong understanding of films and foils properties, processing methods, and their applications in pharmaceutical packaging.

Experience in quality control testing and assurance practices within the packaging industry.

In-depth knowledge of GMP (Good Manufacturing Practices) and other relevant regulatory requirements for pharmaceutical packaging.

High-level analytical and problem-solving abilities to address production issues and drive process improvements.

Excellent verbal and written communication skills, with the ability to work effectively across various departments and stakeholders.

Ability to work independently, manage multiple projects simultaneously, and prioritize tasks effectively.

Strong interpersonal skills and the ability to work collaboratively in a team-oriented environment.

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