QC Incoming Material and Standards Management Specialist

Business Introduction
We manufacture and supply reliable, high-quality medicines and vaccines to meet patients’ needs and drive our performance.
Our network of 37 medicines and vaccines manufacturing sites delivered 1.7 billion packs of medicines and 409 million vaccine doses in 2024 to help make a positive impact on the health of millions of people. Our supply chain is not just core to our operations; it’s vital to bringing our innovations to patients as quickly, efficiently and effectively as possible. Technology is transforming how we manufacture medicines and vaccines, enabling us to increase the speed, quality and scale of product supply.
We need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of smart manufacturing technologies including robotics, digital solutions and artificial intelligence to deliver for patients.


Position Summary
The QC Incoming Material and Standards Management Specialist is responsible for driving the creation, receipt, and control process, testing requirements, disposition and documentation of incoming raw materials and laboratory reference standards to ensure materials meet quality, regulatory and safety requirements. This role supports QC operations by maintaining robust standards management, ensuring traceability, and partnering with Procurement, Suppliers, Manufacturing and Regulatory Affairs to enable compliant material release, qualification, and recertification.

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

• Drive creation and implementation of new required raw materials, intermediates, lab reagents, and reference standards for production and quality control as well as the monography, release, and stability testing required for use.

• Issue RoA (Record of Analysis) with supplemental data (individual replicate data, comparison against previous year’s data, trending analysis, control chart comparisons, etc.)

• Drive material reception/control processes including quarantine, sampling, release, inventory management, and storage for Quality Control materials.

• Maintenance of the Qualification/Re-Qualification Specification documents

• Drive new material creation process for both production and quality including identification of materials and determination of fitness for use, safety requirements, cost effective procurement, and implementation of master data for future reception, release, and control.

• Review Certificates of Analysis (CoAs) and supplier documentation; escalate discrepancies and initiate supplier quality actions when required, manage data generated by 3rd party laboratories (if applicable).

• Create/Refine reception/release, maintenance, and control of laboratory reference standards, internal controls, and working standards: ordering, receipt, qualification/re-qualification, storage, tracking, stability monitoring, and disposal in appropriate LIMs system.

• Implement accurate GMP records in LIMS, SAP, or other quality systems; ensure traceability of lot numbers and storage locations and ensure regulatory filing requirements are accurate.

• Coordinate and/or perform incoming identity and release testing as required by procedures; escalate out-of-specification (OOS) results and support investigations.

Why You?

Basic Qualification
We are seeking professionals with the following required skills and qualifications to help us achieve our goals

• Bachelor’s degree in chemistry, life sciences, or related technical field.

• 3+ years’ experience in a laboratory of a high volume, rapid turnaround testing.

• 3+ years’ experience in a GMP/FDA regulated environment.

• 3+ years’ experience in Quality Control environment

Preferred Qualification
If you have the following characteristics, it would be a plus

• Knowledge of GMP’s, NIH Guidelines, FDA and other regulatory agency requirements sufficient to apply to quality operations, compliance and interfacing with auditors.

• Ability to interface with regulatory auditors.

• Understand when a topic must be escalated and carry out escalation.

• Sense of urgency, flexibility, and accountability.

• Executive capability and leadership to manage people and field projects teams.

• Ability to communicate at all levels.

• Ability to work in a highly complex matrix environment.

• Must be a committed team player prepared to work in and embrace a team-based culture.

• Ability to follow written procedures and do