Job Details

Position Overview:

The Associate, Senior Associate, Principal Associate, Quality Assurance – Materials Management (MMQA Rep) is responsible for the site materials management systems. The MMQA Rep provides quality oversight for the suppliers, service providers, and materials utilized by the site. This position supports all materials management activities relative to the parenteral products site to ensure appropriate Quality Oversight.

 

Responsibilities:

• Maintains a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.
• Works with site staff and global resources to establish site material suppliers for start-up.
• Coordinates the appropriate tasks to develop and maintain the approved supplier list.
• Conducts material, supplier, and service provider risk assessments and periodic reviews of supplier performance.
• Coordinates and writes Supplier, Service Provider, and Affiliate Quality Agreements, including networking with site resources to ensure compliance with associated requirements.
• Provides input, guidance and recommendation for Supplier/Service Provider approval and certification activities.
• Provides support to the warehouse for incoming receipt, sampling and testing.
• Issues complaints/remarks to suppliers and maintains complaint database (track supplier responses for warehouse, incoming and operations complaints).
• Provides input and guidance to site activities (e.g., six sigma, new product/process development, change controls) as a material quality subject matter expert (SME).
• Performs materials SAP data steward functions, as required.
• Revises and/or reviews/approves materials and other GMP documents, including specifications and procedures, as required. Provides procedure ownership and subject matter expertise, as necessary.
• Provides the voice of quality to the Parenteral Supplier Committee, providing input and support as needed to ensure compliance.
• Supports regulatory inspection activities as needed by providing documentation and SME support.
• Tracks and reports materials management metrics to Supplier Relationship Meetings, supplier committees, and Materials Management Governance Committee.
• Leads, as required, local or global teams, committees or other groups to resolve quality issues and ensure site compliance with client Standards and external regulations.

Basic Requirements:

·      Bachelor’s degree in a science, engineering, or pharmaceutical-related field of study or equivalent experience.

·      Minimum 5 years in the pharmaceutical industry with specific materials/supplier management experience.

·      On-site presence required.

Additional Skills/Preferences:

·      Demonstrated understanding of cGMP regulations.

·      Previous experience in GMP production environments.

• Proficiency with material management computer systems and applications including Microsoft Office products, SAP, Regulus and TrackWise or similar systems.
• Ability to influence externally with suppliers and resources across sites.
• Strong technical aptitude and ability to work with component and technical stewards.

·      Demonstrated strong oral and written communication skills.

·      Demonstrated interpersonal skills and the ability to work as a team.

·      Root cause analysis/troubleshooting skills.

·      Demonstrated attention to detail and ability to maintain quality systems.

·      Proven ability to work independently or as part of a Team to resolve an issue.

·      Technical writing and communication skills.

·      Previous regulatory inspection readiness and inspection execution experience.

·      Knowledge of operations business processes such as batch disposition, materials management, laboratory specification/method management.

·      Previous experience with SAP or other inventory management systems.

·      Previous experience with device, packaging, and parenteral product materials.

 

Additional Information:

• Primary location is Kenosha County, Wisconsin
• Ability to work overtime as required