USA-Manufacturing Associate II (Manufacturing/Quality) 1st Shift

USA-Manufacturing Associate II (Manufacturing/Quality) 1st Shift#26-08663 Swiftwater, PA All On-site Job Description 1 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 / SCOPE

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

EEO:

"Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of - Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans."