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
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:
Quality Control
Manufacturing Science and Technology (MSAT)
Sterility Assurance
Operations
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
Overall Equipment Effectiveness (OEE) improvement initiatives
Electronic Batch Record (eBR) implementation and optimization
General factory improvement projects
Facilitate resolution of unresolved issues and deliverables by:
Leading cross‑functional meetings
Positively influencing functional managers
Removing obstacles and barriers to progress
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:
Formulation processes
Filling operations
Lyophilization (freeze‑drying) processes
Comprehensive knowledge of Lean Manufacturing concepts and principles
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.
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Location: Swiftwater, PA
Duration: 12 Months+ Possible Extension
Shift: 1st 9-5pm EST
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:
Quality Control
Manufacturing Science and Technology (MSAT)
Sterility Assurance
Operations
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
Overall Equipment Effectiveness (OEE) improvement initiatives
Electronic Batch Record (eBR) implementation and optimization
General factory improvement projects
Facilitate resolution of unresolved issues and deliverables by:
Leading cross‑functional meetings
Positively influencing functional managers
Removing obstacles and barriers to progress
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:
Formulation processes
Filling operations
Lyophilization (freeze‑drying) processes
Comprehensive knowledge of Lean Manufacturing concepts and principles
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.
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