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 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 RESPONSIBILITIES 

• A 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 and which have been conducted in collaboration with Laboratory, Operations, Commercialization, and Logistics associates as appropriate. 

• 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, 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.  Actively participate in the safety process through completing of safety audits, participating in safety projects, identifying Site Hazards and contributing to safety improvements, and being an attending member of a safety team.  Complete annual safety training as required.  

• 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.  

• RESPONSIBLE CARE:  

a. Be aware of the relevant requirements of the Responsible Care Management System (RC-14001) and follow plant procedures to ensure compliance to requirements. 

 b. Understand the RC-14001 Significant Aspects of your job and help ensure controls are in place to reduce or eliminate negative impacts.  

c. Take actions and identify and communicate ideas to minimize waste, prevent pollution and conserve energy.   

•  HAZARDOUS WASTE HANDLING - All associates who handle hazardous waste shall be given an overview of the regulations and company policies regarding the management of hazardous waste.  The hazardous waste handlers shall receive detailed instruction on the proper handling, collecting, labeling, and transporting of hazardous waste as outlined in RCRA and OSHA regulations.  Instructions shall also include whom to notify in case of a spill and proper procedures for spill response.  Educational requirements include the ability to understand and carry out oral and written instructions.  Instructions on handling hazardous waste shall come from the hazardous waste manager or appropriate designee. 

ENVIRONMENTAL, HEALTH, SAFETY & SECURITY RESPONSIBILITIES 

• Understand the relevant requirements of the Responsible Care Management System (RCMS) and RC-14001 certification. 

• Understand the importance of conformance to the Environmental, Safety and Responsible Care Policies, procedures, and the requirements of the RCMS. 

• Understand the significant environmental impacts associated with their work activities and help ensure controls are in place to reduce or eliminate negative impacts. 

• Understand the potential consequences of deviation from specified operating procedures.  

• Immediately report any accidents and releases per the company escalation protocol.  

• Comply with all environmental, health, safety, and security rules; Environmental, Safety, and Responsible Care policies and programs established by the company to the extent of training received. 

• Recognize that adhering to job responsibilities and procedures regarding environmental, safety, security, and health is a condition of employment. 

• Contribute to continuous improvement of the plant environmental, health, safety, security, and Responsible Care performance and programs. 

QUALIFICATIONS – REQUIRED 

• 3+ years of experience supporting manufacturing (i.e., Engineering, Technical Services, Quality Assurance) in the Consumer Products or chemical industries. Previous supervisory experience a plus. 

• 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, as well as presentation skills. 

The successful candidate will have strengths in the following: 

Requires a bachelor’s degree with a strong emphasis in a natural science or engineering field, Chemical Engineering preferred. Master’s degree a plus.