Quality Systems Analyst

Become part of a team that champions wellness worldwide. CAPTEK® Softgel International is a global leader in the development and production of high-quality nutraceutical supplements. As a contract manufacturer organization (CMO), we collaborate with innovators from some of the world’s most successful brands.

Summary: Quality Systems Analyst is responsible for monitoring, analyzing and continually improving the compliance of the quality systems and manufacturing processes. Manages Batch Record Reviewers to ensure process improvements are well-planned, executed, and compliant. Directly responsible for driving improvements in compliance with applicable regulations, standards and SOP's as well as improving overall productivity.

Essential Duties and Responsibilities:

• Analyzes continuous improvement of the factory internal quality audit program, and monitors trends to solve chronic issues
• Develops Corrective Action and Preventive Action (CAPA) plans to lead continuous improvement initiatives.
• Collaborates with supervisors and managers in effort to address findings and implement improvement projects.
• Oversees on-time closure of assigned deviations and analyzes CAPA system for trends and effectiveness
• Documents results of new procedures after implementation to show quality improvements.
• Develops and implements test procedures to obtain the defect information needed for analysis and report findings from test and inspection data to management.
• Analyzes quality inspection data to identify quality problems and perform root cause analysis.
• Initiates quality related investigations and supports deviation documentation process utilizing the company’s electronic database system.
• Assists in collecting and reporting weekly and monthly Quality reports, e.g., First Pass Quality (FPQ), quality complaints, Non-Conformance Report (NCR), deviations, and others as assigned.
• Makes recommendations to improve the production process based on findings from quality assurance analysis of the FPQ results.
• Monitors improvement procedures to determine if changes significantly improve the process and the defect quantities.
• Creates new processes or modifies and improve current processes by setting up clear and definite quality systems and SOPs.
• Monitors quality compliance with the company’s standard operating procedure requirements and applicable regulations.
• Collaborates across multiple disciplines and interfaces closely with our Operations, Distribution, R&D, Technical services and Procurement teams.
• Participates in multi-function team activities, support and maintain Quality Systems and perform other assignments as directed by Manager.

Qualifications:

• Excellent knowledge of Quality Management Systems (NCR, CAPA, Deviations, Document Control, Audits, etc..)
• Excellent Problem solving and statistical skills using quality tools (Pareto analysis, statistical process control, multi-variant DOE etc.).
• Knowledge of regulatory and compliance requirements such as 21 CFR Part 111.
• Experience in project planning, and project management.
• Proficient with Microsoft Excel, PowerPoint and Microsoft.
• Excellent written and verbal communication, presentation and interpersonal skills.
• Strong understanding of sampling techniques.
• Experience in process capability studies.
• Experience in process and equipment validation.
• Six Sigma green belt or higher, preferred.
• Working HACCP knowledge, preferred.
• Certified Quality Auditor, preferred.

Education/Experience:

• 3-5 years of experience in the food, pharmaceutical and/ or supplement industry.
• Bachelors in Pharmaceutical, Food Science, Chemical Engineering, Chemistry or other Science related field, preferred.
• ASQ CQE or CQM, preferred

Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is occasionally exposed to work near moving mechanical parts, fumes, or airborne particles and risk of electrical shock. The noise level in the work environment is usually moderate.

Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Physical demands require sitting, walking, bending, reaching, carrying, and occasionally lifting and/or moving objects up to 25 pounds. Specific vision abilities required by this job include Close vision, Peripheral vision, and the ability to adjust focus. While performing the duties of this job, the employee is occasionally required to use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and talk or hear.

Thank you for your interest in joining the CAPTEK team. You will be contacted shortly if your application is selected.