Quality Control Representative

Qualifications

• Associate’s degree or equivalent advanced education or training.

• Strong knowledge of manufacturing operations, quality, and supplier quality management (preferred).

• Experience with SAP, TrackWise, and Veeva QualityDocs (preferred).

• Experience in Change Management.

• High proficiency with MS Office (Teams, OneNote, OneDrive, SharePoint, PowerPoint, Excel).

• Proven ability to communicate and deliver constructive feedback, with strong interpersonal, oral presentation, and written communication skills.

• Demonstrated creativity in strategy development and problem solving.

• Ability to work both independently and collaboratively with minimal supervision.

• Ability to communicate, influence, and train effectively.

Additional Skills/Preferences

• Minimum of five (5) years of experience at a manufacturing site within a QA organization.

• Strong knowledge of quality management, supplier quality management, ISO, and GMPs.

• Experience with PowerApps, Power BI, Tableau.

• Familiarity with GQS, CQP, LQP.

• Proficient English oral and written communication.

• Ability to travel to manufacturing sites as required.

Responsibilities

The Quality Control Representative is responsible for executing the Global Supplier Quality Management (GSQM) Program in support of new site expansions. The role ensures effective and timely onboarding of suppliers, materials, and GMP service providers to support supply chain and affiliate project timelines. This position partners closely with cross-functional business teams to ensure consistent implementation across networks and functions.

The GSQM program promotes a globally consistent and holistic approach to GMP supplier and GMP service provider management, ensuring strong compliance, patient safety, product quality, and robust technical standards.

Key Objectives / Deliverables

Activities will be performed according to established procedures, guidelines, forms, and tools.

Responsibilities include, but are not limited to:

• Execute supplier quality management processes in accordance with Global Quality Standards (GQS305, GQS301, GQS307, and others as applicable).

• Support procurement, supply chain, GQAAC, MMQA, TS/MS, and manufacturing teams in identifying and managing material suppliers and GMP service providers.

• Perform SAP and TW138 activities related to the Approved Supplier List (ASL) on behalf of site expansions; collaborate with SAP Business QA as needed.

• Coordinate with manufacturing and affiliate sites across the network (API, Manufacturing, Packaging, DPEM, APIEM, Devices) to ensure robust and effective process execution, escalating barriers where necessary.

• Develop and communicate processes associated with the GSQM program and related initiatives.

• Support the maintenance of supplier quality management data, including approved supplier and GMP service provider lists, in systems such as SAP, VeevaVault (QDocs), and TrackWise.

• Assist with Certification Package Review Boards and global certification packages for SAP Manufacturing Plants (MPs) materials.

• Collaborate with Global TS/MS to execute material risk control strategies, including material risk, product acceptance risk, and specification controls.

• Provide input and support for supplier-related change controls.

This role requires maintaining comprehensive knowledge of applicable regulations, technical requirements, and training to fulfill these responsibilities.

Personal Development

• Stay current on industry trends and regulatory interpretations of GMP/cGMP requirements, especially those related to Supplier Management Programs.

• Maintain strong interpersonal, verbal, and technical writing skills.

• Complete required training and qualifications outlined in the Learning Plan (LP).