Process Improvement Specialist
Integrated Resources, Inc ( IRI ), Swiftwater, PA, United States
Job Title: Manufacturing Associate II/Continuous Improvement professional
Location: Swiftwater, PA
Duration: 12 Months+ Possible Extension
Shift: 1st 9-5pm EST
Manager Notes: Continuous Improvement professional with 3–5 years of experience in pharmaceutical manufacturing and strong knowledge of cGMP environments, particularly in formulation and filling operations. Hands‐on experience managing CAPA and Change Control activities, authoring technical documentation, and supporting cross‐functional teams including Quality, MSAT, Engineering, Operations, and Sterility Assurance. They should bring expertise in Lean/Six Sigma methodologies, equipment qualification, OEE improvement, and electronic systems such as eBR, Opstrakker, and Qualipso. Strong candidates excel in communication, technical writing, project management, and influencing across teams. Proficiency with Microsoft Office and familiarity with ERP systems (iShift preferred) are important. Candidates must be adaptable, detail‐oriented, and capable of driving continuous improvement in a fast‐paced, regulated environment.
PROJECT SUMMARY: The position will provide dedicated support to the Continuous Improvement Group, with primary focus on the Formulation and Filling Areas.
2 TECHNICAL TASKS AND DELIVERABLES / Product: The Continuous Improvement Contractor will execute the following activities and responsibilities:
2.1 Cross-Functional Collaboration and Support • Serve as an individual contributor and active member of cross-functional teams providing support to Production Control Units (PCUs) • Act as CAPA (Corrective and Preventive Action) and Change Control point of contact for the Formulation and Filling Improvement Program (FFIP), with emphasis on Formulation and Filling areas • Facilitate cross-functional interfacing activities with key stakeholders in a positive and collaborative manner, including, but not limited to: o Quality Control o Manufacturing Science and Technology (MSAT) o Sterility Assurance o Engineering o Operations o Quality Assurance
2.2 CAPA and Change Control Management • Complete all required training to independently own CAPA action items, Change Control action items, and author related documents • Ensure timely closure of assigned CAPA and Change Control action items • Maintain accountability for deliverables and adherence to established timelines
2.3 Technical Support and Process Improvement • Provide technical support for: o Component qualification activities o Overall Equipment Effectiveness (OEE) improvement initiatives o Electronic Batch Record (eBR) implementation and optimization o Opstrakker system utilization o General factory improvement projects • Facilitate resolution of unresolved issues and deliverables by: o Leading cross-functional meetings o Positively influencing functional managers o Removing obstacles and barriers to progress o Managing projects and competing priorities effectively
2.4 Operational Excellence and Metrics Management • Create and maintain a proactive operational environment • Monitor and communicate key performance metrics to team members and support functions • Utilize the "+QDCI" Visual Management Systems to drive continuous improvement in key metrics • Work within the Continuous Improvement framework to identify and implement improvement opportunities
2.5 Compliance and Quality Assurance • Ensure strict compliance with all regulatory requirements and current Good Manufacturing Practices (cGMPs) • Maintain adherence to good documentation practices to ensure delivery of safe, quality, and effective products • Support regulatory inspections and audits as required
2.6 Professional Development • Proactively identify opportunities for professional growth and development • Stay current with applicable sciences and methodologies that enhance team capabilities • Contribute to knowledge sharing and team skill development
3 REQUIRED SKILLS AND QUALIFICATIONS Experience: 3-5 years experience in technical documentation and cGMP systems. 3.1 Technical Knowledge and Expertise • Manufacturing Operations: Deep understanding of cGMPs and pharmaceutical manufacturing activities, including: o Formulation processes o Filling operations o Lyophilization (freeze-drying) processes • Continuous Improvement Methodologies: o Comprehensive knowledge of Lean Manufacturing concepts and principles o Six Sigma methodology and tools • Change Management: Demonstrated experience in Change Management processes and execution • Protocol and Report Development: Proven experience in authoring protocols and technical reports
3.2 Systems and Tools Proficiency • Microsoft Office Suite: Proficient in Excel, Word, and PowerPoint • Enterprise Resource Planning (ERP): Knowledge of ERP systems (iShift preferred) • Quality Management Systems: Experience with Quality Management Systems (Qualipso) • Electronic Systems: Familiarity with eBR and Opstrakker systems
3.3 Core Competencies and Soft Skills • Communication: Excellent interpersonal and communication skills with ability to engage effectively across all organizational levels • Leadership: Strong management by influence skills; ability to lead and actively participate on cross-functional teams • Technical Writing: Excellent technical writing skills for generation of protocols, reports, and Change Controls • Project Management: Strong project management and organizational skills • Time Management: Demonstrated ability to prioritize tasks and manage time effectively in a fast-paced environment • Flexibility: Adaptability to change priorities and business needs • Problem-Solving: Analytical mindset with ability to identify root causes and implement effective solutions.
Manager Notes: Continuous Improvement professional with 3–5 years of experience in pharmaceutical manufacturing and strong knowledge of cGMP environments, particularly in formulation and filling operations. Hands‐on experience managing CAPA and Change Control activities, authoring technical documentation, and supporting cross‐functional teams including Quality, MSAT, Engineering, Operations, and Sterility Assurance. They should bring expertise in Lean/Six Sigma methodologies, equipment qualification, OEE improvement, and electronic systems such as eBR, Opstrakker, and Qualipso. Strong candidates excel in communication, technical writing, project management, and influencing across teams. Proficiency with Microsoft Office and familiarity with ERP systems (iShift preferred) are important. Candidates must be adaptable, detail‐oriented, and capable of driving continuous improvement in a fast‐paced, regulated environment.
PROJECT SUMMARY: The position will provide dedicated support to the Continuous Improvement Group, with primary focus on the Formulation and Filling Areas.
2 TECHNICAL TASKS AND DELIVERABLES / Product: The Continuous Improvement Contractor will execute the following activities and responsibilities:
2.1 Cross-Functional Collaboration and Support • Serve as an individual contributor and active member of cross-functional teams providing support to Production Control Units (PCUs) • Act as CAPA (Corrective and Preventive Action) and Change Control point of contact for the Formulation and Filling Improvement Program (FFIP), with emphasis on Formulation and Filling areas • Facilitate cross-functional interfacing activities with key stakeholders in a positive and collaborative manner, including, but not limited to: o Quality Control o Manufacturing Science and Technology (MSAT) o Sterility Assurance o Engineering o Operations o Quality Assurance
2.2 CAPA and Change Control Management • Complete all required training to independently own CAPA action items, Change Control action items, and author related documents • Ensure timely closure of assigned CAPA and Change Control action items • Maintain accountability for deliverables and adherence to established timelines
2.3 Technical Support and Process Improvement • Provide technical support for: o Component qualification activities o Overall Equipment Effectiveness (OEE) improvement initiatives o Electronic Batch Record (eBR) implementation and optimization o Opstrakker system utilization o General factory improvement projects • Facilitate resolution of unresolved issues and deliverables by: o Leading cross-functional meetings o Positively influencing functional managers o Removing obstacles and barriers to progress o Managing projects and competing priorities effectively
2.4 Operational Excellence and Metrics Management • Create and maintain a proactive operational environment • Monitor and communicate key performance metrics to team members and support functions • Utilize the "+QDCI" Visual Management Systems to drive continuous improvement in key metrics • Work within the Continuous Improvement framework to identify and implement improvement opportunities
2.5 Compliance and Quality Assurance • Ensure strict compliance with all regulatory requirements and current Good Manufacturing Practices (cGMPs) • Maintain adherence to good documentation practices to ensure delivery of safe, quality, and effective products • Support regulatory inspections and audits as required
2.6 Professional Development • Proactively identify opportunities for professional growth and development • Stay current with applicable sciences and methodologies that enhance team capabilities • Contribute to knowledge sharing and team skill development
3 REQUIRED SKILLS AND QUALIFICATIONS Experience: 3-5 years experience in technical documentation and cGMP systems. 3.1 Technical Knowledge and Expertise • Manufacturing Operations: Deep understanding of cGMPs and pharmaceutical manufacturing activities, including: o Formulation processes o Filling operations o Lyophilization (freeze-drying) processes • Continuous Improvement Methodologies: o Comprehensive knowledge of Lean Manufacturing concepts and principles o Six Sigma methodology and tools • Change Management: Demonstrated experience in Change Management processes and execution • Protocol and Report Development: Proven experience in authoring protocols and technical reports
3.2 Systems and Tools Proficiency • Microsoft Office Suite: Proficient in Excel, Word, and PowerPoint • Enterprise Resource Planning (ERP): Knowledge of ERP systems (iShift preferred) • Quality Management Systems: Experience with Quality Management Systems (Qualipso) • Electronic Systems: Familiarity with eBR and Opstrakker systems
3.3 Core Competencies and Soft Skills • Communication: Excellent interpersonal and communication skills with ability to engage effectively across all organizational levels • Leadership: Strong management by influence skills; ability to lead and actively participate on cross-functional teams • Technical Writing: Excellent technical writing skills for generation of protocols, reports, and Change Controls • Project Management: Strong project management and organizational skills • Time Management: Demonstrated ability to prioritize tasks and manage time effectively in a fast-paced environment • Flexibility: Adaptability to change priorities and business needs • Problem-Solving: Analytical mindset with ability to identify root causes and implement effective solutions.