Encapsys Quality Assurance Manager, Encapsys

COMPANY OVERVIEW

This 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 OVERVIEW

The Quality Assurance Manager is a member of the Plant Manager’s leadership team and is responsible for implementation and execution of the Iso9001 & iCompliance compliant Quality Management System at the Ironwood plant site. The position ensures that the site remains in a state of compliance by providing expertise on standards and providing oversight and leadership for quality investigations, audits, data reviews, validation /qualification projects, and the preparation and delivery of GMP related training.

 

JOB RESPONSIBILITIES

• A Quality culture at the Ironwood site which relentlessly pursues superior quality for all Encapsys customers.
• Improvement and Validation Master Plans which drive continuous improvement at the site.
• Participate in 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 and which have been conducted in collaboration with Laboratory, Operations, Commercialization, and Logistics associates as appropriate.
• Timely and effective Corrective and Preventive Action program.
• Responsible for the site micro daily management plans.
• Fully engaged Quality team members across the Ironwood Site.

Accountabilities:

 

• Oversight of the Encapsys Quality Management System (QMS) at the Ironwood site, including:

• 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. Participates in projects to ensure facilities, utilities, equipment, test methods, and computer systems are appropriately validated/qualified.
• 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 (setting and modifying objectives, giving prompt corrective feedback as well as praise, coaching for improved or sustained performance, reviewing performance, conducting salary planning), career development (planning and holding regular discussions with employees about their personal growth and development, including career goals), and building open and trusting relationships that further high employee performance and engagement.

 

• SAFETY – Adhere to all plant safety policies and compliance regulations.