Quality Systems Analyst

CAPTEK Softgel International provided pay range

This range is provided by CAPTEK Softgel International. Your actual pay will be based on your skills and experience talk with your recruiter to learn more.

Base pay range

$70,000.00 / yr - $75,000.00 / yr

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 SOPs 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 companys 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 improves current processes by setting up clear and definite quality systems and SOPs
• Monitors quality compliance with the companys standard operating procedure requirements and applicable regulations
• Collaborates across multiple disciplines and interfaces closely with Operations, Distribution, R&D, Technical services and Procurement teams
• Participates in multi?function team activities, supports and maintains Quality Systems and performs other assignments as directed by Manager

Qualifications

Education / Experience

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.

Seniority level

Mid?Senior level

Employment type

Full?time

Job function

Quality Assurance

Industries : Wellness and Fitness Services, Food and Beverage Manufacturing, and Pharmaceutical Manufacturing

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