Milliken and Company
Quality Assurance Manager, Encapsys
Milliken and Company, Portage, Wisconsin, United States, 53901
Quality Assurance Manager, Encapsys
Date:
Sep 24, 2024Location:
Portage, WI, US, 53901Company:
Milliken and CompanyCOMPANY OVERVIEWThis position is located in Portage, Wisconsin. At Milliken, our work begins behind the scenes often taking shape in a lab. The molecules and materials we create are transforming lives and experiences around the world. We're a global leader with over 155 years of expertise in research, design and manufacturing specializing in the textile, chemical, healthcare, and flooring industries.Headquartered in Spartanburg, South Carolina, our eight thousand associates across 46 locations are a diverse global team of scientists, engineers, manufacturers, designers, thinkers, and problem solvers. People who come to work every day with curious minds and an unwavering commitment to delivering sustainable solutions for our customers and communities. Named to the World’s Most Ethical Companies list by Ethisphere Institute for 15 consecutive years, we rally behind a common purpose: to positively impact the world for generations.POSITION OVERVIEWThe Quality Assurance Manager is a member of the Plant Manager’s leadership team and is responsible for implementation and execution of the cGMP compliant Quality Management System at the Ironwood plant site. The position ensures that the site remains in a state of GMP compliance by providing expertise on GMP and providing oversight and leadership for quality investigations, audits, data reviews, validation/qualification projects, and the preparation and delivery of GMP related training.JOB RESPONSIBILITIESA Quality culture at the Ironwood site which relentlessly pursues superior quality for all Encapsys customers.Self-Improvement and Validation Master Plans which drive continuous improvement at the site.An effective Change Management program across the Ironwood site which ensures all systems and processes remain in a validated status.Quality Investigations which are clear, concise, and supported by sound technical justification leading to an Assignable Root Cause.Timely and effective Corrective and Preventive Action program.Fully engaged Quality team members across the Ironwood Site.Accountabilities:Oversight of the Encapsys Quality Management System (QMS) at the Ironwood site.Site administrator for the EtQ Reliance eQMS system.Ensures that the site stays in compliance with approved client/Encapsys Quality Agreements.In collaboration with the Operations team, executes site process control strategy by monitoring and trending Critical to Quality Process Parameters.Reviews and is the Quality approver for all the site’s controlled documents (SOPs, Policies, etc.) to ensure compliance with cGMP, Encapsys document management procedures, and customer requirements.Reviews and approves Quality System Outage documentation, including deviations, investigations, CAPAs, and change controls.Responsible for review and approval of validation protocols and reports.Conducts internal audits according to policy and schedule, oversees corrective and preventive action execution against self-identified findings and observations.Leads and executes the Ironwood Environmental Monitoring Program to ensure product quality is not compromised by the manufacturing environment.Develops, prepares, and delivers GMP/Quality/Regulatory training for new employees as part of onboarding process.Manages direct reports effectively, including performance management and career development.SAFETY
– Adhere to all plant safety policies and compliance regulations.QUALITY
– Become familiar with, understand and comply with Milliken Quality Policy, Standard Operating Procedure(s) (SOPs), relevant ISO 9000 standards and Company Policies that are applicable to this position.QUALIFICATIONS – REQUIRED3+ years of experience supporting manufacturing (i.e., Engineering, Technical Services, Quality Assurance) in the Consumer Products or chemical industries.Demonstrated expertise in Quality Systems, cGMP, and laboratory operations.Basic knowledge of chemical batch processing (including process control), Clean Design, and microbiology.Ability to facilitate and drive complex problem solving to resolve quality issues.Proficient with problem solving, analysis and presentation tools.Knowledge of quality data management tracking and statistical analysis tools.Demonstrated ability to communicate with internal and external customers, including strong oral and written communication skills and interpersonal interaction skills.Requires a bachelor’s degree with a strong emphasis in a natural science or engineering field, Chemical Engineering preferred. Master’s degree a plus.
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Date:
Sep 24, 2024Location:
Portage, WI, US, 53901Company:
Milliken and CompanyCOMPANY OVERVIEWThis position is located in Portage, Wisconsin. At Milliken, our work begins behind the scenes often taking shape in a lab. The molecules and materials we create are transforming lives and experiences around the world. We're a global leader with over 155 years of expertise in research, design and manufacturing specializing in the textile, chemical, healthcare, and flooring industries.Headquartered in Spartanburg, South Carolina, our eight thousand associates across 46 locations are a diverse global team of scientists, engineers, manufacturers, designers, thinkers, and problem solvers. People who come to work every day with curious minds and an unwavering commitment to delivering sustainable solutions for our customers and communities. Named to the World’s Most Ethical Companies list by Ethisphere Institute for 15 consecutive years, we rally behind a common purpose: to positively impact the world for generations.POSITION OVERVIEWThe Quality Assurance Manager is a member of the Plant Manager’s leadership team and is responsible for implementation and execution of the cGMP compliant Quality Management System at the Ironwood plant site. The position ensures that the site remains in a state of GMP compliance by providing expertise on GMP and providing oversight and leadership for quality investigations, audits, data reviews, validation/qualification projects, and the preparation and delivery of GMP related training.JOB RESPONSIBILITIESA Quality culture at the Ironwood site which relentlessly pursues superior quality for all Encapsys customers.Self-Improvement and Validation Master Plans which drive continuous improvement at the site.An effective Change Management program across the Ironwood site which ensures all systems and processes remain in a validated status.Quality Investigations which are clear, concise, and supported by sound technical justification leading to an Assignable Root Cause.Timely and effective Corrective and Preventive Action program.Fully engaged Quality team members across the Ironwood Site.Accountabilities:Oversight of the Encapsys Quality Management System (QMS) at the Ironwood site.Site administrator for the EtQ Reliance eQMS system.Ensures that the site stays in compliance with approved client/Encapsys Quality Agreements.In collaboration with the Operations team, executes site process control strategy by monitoring and trending Critical to Quality Process Parameters.Reviews and is the Quality approver for all the site’s controlled documents (SOPs, Policies, etc.) to ensure compliance with cGMP, Encapsys document management procedures, and customer requirements.Reviews and approves Quality System Outage documentation, including deviations, investigations, CAPAs, and change controls.Responsible for review and approval of validation protocols and reports.Conducts internal audits according to policy and schedule, oversees corrective and preventive action execution against self-identified findings and observations.Leads and executes the Ironwood Environmental Monitoring Program to ensure product quality is not compromised by the manufacturing environment.Develops, prepares, and delivers GMP/Quality/Regulatory training for new employees as part of onboarding process.Manages direct reports effectively, including performance management and career development.SAFETY
– Adhere to all plant safety policies and compliance regulations.QUALITY
– Become familiar with, understand and comply with Milliken Quality Policy, Standard Operating Procedure(s) (SOPs), relevant ISO 9000 standards and Company Policies that are applicable to this position.QUALIFICATIONS – REQUIRED3+ years of experience supporting manufacturing (i.e., Engineering, Technical Services, Quality Assurance) in the Consumer Products or chemical industries.Demonstrated expertise in Quality Systems, cGMP, and laboratory operations.Basic knowledge of chemical batch processing (including process control), Clean Design, and microbiology.Ability to facilitate and drive complex problem solving to resolve quality issues.Proficient with problem solving, analysis and presentation tools.Knowledge of quality data management tracking and statistical analysis tools.Demonstrated ability to communicate with internal and external customers, including strong oral and written communication skills and interpersonal interaction skills.Requires a bachelor’s degree with a strong emphasis in a natural science or engineering field, Chemical Engineering preferred. Master’s degree a plus.
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