Manufacturing Specialist - CAPA & Change Controls

job summary: As the largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. Located in 100 countries, our longtime partner is known for being the world's largest producer of vaccines and for covering seven major therapeutic areas. To be a part of the science that is changing the world, apply now!

location: Swiftwater, Pennsylvania job type: Contract salary: $30.00 - 31.88 per hour work hours: 9 to 5 education: High School

responsibilities: The position will provide dedicated support to the Continuous Improvement Group, with primary focus on the Formulation and Filling Areas.

Job Responsibilities

The Continuous Improvement Contractor will execute the following activities and responsibilities:

• 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
• Engineering
• Operations
• Quality Assurance

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
• Technical Support and Process Improvement
• Provide technical support for:

• Component qualification activities
• Overall Equipment Effectiveness (OEE) improvement initiatives
• Electronic Batch Record (eBR) implementation and optimization
• Opstrakker system utilization
• 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

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

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

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

qualifications:

• Experience: 3-5 years experience in technical documentation and cGMP systems.

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:

• 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

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

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

#LI-HK1

skills: ERP System, Good Manufacturing Practices (GMP), Quality Management Systems (QMS)

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).

This posting is open for thirty (30) days.

Any consideration of a background check would be an individualized assessment based on the applicant or employee's specific record and the duties and requirements of the specific job.

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The position will provide dedicated support to the Continuous Improvement Group, with primary focus on the Formulation and Filling Areas.

Job Responsibilities

The Continuous Improvement Contractor will execute the following activities and responsibilities:

• 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
• Engineering
• Operations
• Quality Assurance

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
• Technical Support and Process Improvement
• Provide technical support for:

• Component qualification activities
• Overall Equipment Effectiveness (OEE) improvement initiatives
• Electronic Batch Record (eBR) implementation and optimization
• Opstrakker system utilization
• 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

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

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

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

ERP System, Good Manufacturing Practices (GMP), Quality Management Systems (QMS)