Associate Specialist, Quality

Job Description

Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interlinking global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

• Provide direct shop floor support (i.e. counts, material tagging, production event support, etc.
• Provide quality oversight of the packaging process and plant site
• Evaluate defect resolution and the control of material throughout the plant | Defect resolution, including use of statistical methods, and control of material throughout the plant site | Apply material control
• Provide guidance to packaging operation to ensure compliance with Company Quality policies, GMP’s and other agency regulations for application to Wilson Operations
• Perform batch record review activities of intermediate/finished product
• Maintains 5S organization and identifies improvement opportunities
• Trends a variety of compliance performance indicators and works to drive compliance improvement
• Participates in the implementation of new programs/regulations/divisional processes at the site
• Identifies continuous improvement (business and compliance excellence) opportunities and through partnership and engagement with other functional groups, implements changes to processes
• Provides Quality Assurance review and approval of GMP-related SOPs. Assist in the development of procedures to improve compliance status of Wilson operations
• Participates in plant investigation root cause analysis, corrective action identification, and recommendation of affected material disposition, if required
• Participates in projects, if required
• Demonstrates leadership by maintaining a safe workplace and identifying actions to prevent safety incidents
• Builds and promotes Team effectiveness through actions that demonstrate respect and appreciation for diverse perspectives
• Ability to interpret Company Quality Policies and Guidelines for daily application

• High School Diploma AND at least Three (3) years in a manufacturing, technical, support, or Military role. OR
• Bachelor’s degree preferred in the field of science

• Team Building through respect and diversity
• Knowledge and exposure to fundamental theories, principles, and concepts in the Quality Assurance discipline, including the knowledge and understanding of pharmaceutical operations systems
• Strategic comprehension and appreciation of customer needs, requirements and expectations
• Speaks up on tough issues and expresses views and ideas at the right time while actively encouraging Team members to make suggestions and share ideas
• Technical writing capabilities and be able to compile straightforward investigations and procedures
• One to four years pharmaceutical industry exposure
• Comprehends and applies regulatory/compliance requirements, including GMP, NDA, and related regulations, and has the ability to interpret those regulations for implementation in the workplace
• Must be able to work 3rd shift support. (Sunday-Thursday 11:30PM - 8:00AM).

Adaptability, Adaptability, Analytical Problem Solving, Aseptic Manufacturing, Auditing, Cleaning Equipment, Customer Communications, Data Analysis, Engineering Physics, Environmental Monitoring, Equipment Maintenance, GMP Compliance, Inventory Accuracy, Inventory Control Management, Inventory Maintenance, Inventory Management, Inventory Management System, Laboratory…