Continuous Improvement Contractor

Job Title: Continuous Improvement Contractor
Location: Swiftwater, PA
Duration: 12 months + possible extension

Shift: 1st Shift, 9:00 am – 5:00 pm EST
 
Overview:
The Continuous Improvement Professional / Manufacturing Associate II will provide dedicated support to the Continuous Improvement Group, focusing primarily on Formulation and Filling areas within a pharmaceutical manufacturing environment. The role requires hands-on experience with CAPA, Change Control, technical documentation, and cross-functional collaboration in a cGMP-regulated setting. The position emphasizes process improvement, operational excellence, and adherence to quality standards.
 
Key Responsibilities:
1. Cross-Functional Collaboration and Support

• Act as an active member of cross-functional teams supporting Production Control Units (PCUs).
• Serve as the CAPA and Change Control point of contact for the Formulation and Filling Improvement Program (FFIP).
• Facilitate effective collaboration with key stakeholders including:
  • Quality Control (QC)
  • Manufacturing Science and Technology (MSAT)
  • Sterility Assurance
  • Engineering
  • Operations
  • Quality Assurance (QA)

2. CAPA and Change Control Management

• Complete required training to independently manage CAPA and Change Control action items.
• Ensure timely closure of assigned tasks and maintain accountability for deliverables.
• Author technical documentation related to CAPA and Change Control processes.

3. Technical Support and Process Improvement

• Support component qualification activities and overall equipment effectiveness (OEE) improvement initiatives.
• Assist with implementation and optimization of electronic batch record (eBR) and Opstrakker systems.
• Lead cross-functional meetings, remove obstacles, and influence stakeholders to resolve issues.
• Manage multiple projects and competing priorities efficiently.

4. Operational Excellence and Metrics Management

• Monitor and communicate key performance metrics to team members and stakeholders.
• Utilize "+QDCI" Visual Management Systems to drive continuous improvement initiatives.
• Identify and implement process improvement opportunities within the Continuous Improvement framework.

5. Compliance and Quality Assurance

• Ensure compliance with all regulatory requirements and cGMPs.
• Maintain good documentation practices to guarantee safe, quality products.
• Support regulatory inspections and audits as required.

6. Professional Development

• Identify opportunities for personal and professional growth.
• Stay current with relevant methodologies, technologies, and regulatory requirements.
• Contribute to team knowledge sharing and skill development.

 
Required Skills and Qualifications:
Experience:

• 3–5 years of experience in pharmaceutical manufacturing, including formulation and filling operations.
• Hands-on experience managing CAPA, Change Control, and authoring technical documentation in cGMP environments.

Technical Knowledge:

• Formulation processes, filling operations, and lyophilization.
• Lean Manufacturing and Six Sigma methodologies.
• Change Management execution and protocol/report development.

Systems and Tools:

• Microsoft Office Suite (Excel, Word, PowerPoint).
• ERP systems (iShift preferred).
• Quality Management Systems (Qualipso).
• Electronic Batch Record (eBR) and Opstrakker systems.

Core Competencies and Soft Skills:

• Excellent communication and interpersonal skills for cross-functional collaboration.
• Ability to influence and lead teams without formal authority.
• Strong technical writing skills for protocols, reports, and Change Control documentation.
• Project management, organizational, and time management skills.
• Adaptability to changing priorities and business needs.
• Analytical mindset with strong problem-solving capabilities.