Job Description

​Job Description:

Reporting directly to the Quality Assurance and Lab Manager, this position uses critical thinking and technical writing skills to research, develop and document key quality processes such as process and software validations, procedures, risk assessments, PFMEAs, as assigned in a timely manner. This role supports all levels of operations, quality, laboratory, and engineering departments in the development, management and execution of testing and validation protocols. This position will service all aspects of the businesses at PCNA. This role supports the Engineering team with maintaining the facilities’ master validation plan. Facilitates the company’s Management of Change (MOC) process. Maintain outgoing process data for statistical analyses, trending purposes to ensure the process is maintained as validated. Continuous Improvement Coach and Coordinator. Perform data analyses using ERP, PowerBI, Excel, etc.

Position Requirements:

• Bachelor’s degree in engineering (Biomedical, Mechanical, etc), Science (Chemistry, Biology, Physics, etc.), or Math (Statistics) required
• Minimum of 5 years of experience in an industrial manufacturing environment with a quality system designed to meet the requirements of the FDA Quality System required
• Proficient in Microsoft Office is required
• GMP in Cosmetics or Pharmaceuticals experience is preferred
• Certifications in quality, engineering, Six Sigma, or Lean Manufacturing are preferred
• Experience with Microsoft Business Dynamics preferred
• Experience with Power BI preferred

• Perform root cause investigation and CAPA (corrective action preventative action) to deliver non-repeatable issues, measure effective performance of CAPA solutions.
• Develop, lead and drive optimization Kaizens related to top quality losses.
• Lead data collection, analysis and assignment of standard Quality loss trees in support of operational KPI reporting.
• Support the development of PFMEA documents, perform risk assessment and updated PFMEA documents for equipment and processes as needed.
• Partner with department leaders to execute validations and provide support for validation including report writing, and participation.

• Create new SOPs and modify current SOPs using the established structured format; which will allow for production operator to perform and produce the same outcome every time the process is executed.

• Leads and develops and manages the layered process audit program.
• Manage and ensure compliance with the quality management system through communication, training and internal/external audits.
• Assess training and development needs related to the quality program.
• Ensure that all training activities associated with validation activities are performed in a timely manner.
• Implement and verify site calibration and maintenance program for inspection, measuring and testing equipment. Coordinate performance of quality measurement equipment capabilities studies.
• Initiate and support Management of Change (MOC) per requirements.
• Support the documentation of maintenance procedures to ensure the production of quality products.
• Provide insights to trends and performance of processes through data analysis.
• Support efforts to implement and maintain the all company certification and regulations including, SQF, ISO 9001, ISO/IEC 17025, and RC14001/EHS&S management system.

• Support innovation funnel activities with key customers by partnering with process engineering and operations departments to support IQ/OQ/PQ processes.
• Develop timely validation and test protocols for new processes, computer software, or equipment in conjunction with the engineering group.
• Establish and maintain systems to maintain raw materials, finished goods within specification.
• Supports and participates in structured quality improvement activities related to customers, consumer issues/complaints and PQ gaps.

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