QC Incoming Material and Standards Management Specialist

GSK • Marietta, PA

13d • Onsite

About The Position

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.

Requirements

• 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

Nice To Haves

• 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 document results in a neat and precise manner.
• Intermediate computer skills required.
• Proven record of providing excellent internal and external customer service.
• Stay current on developments in the field and GSK-Bio Standards.
• Work within a Multi-skilled team.
• Maintain attention to detail, while completing multiple or repetitive tasks.
• Demonstrate a serious commitment to accuracy and quality while meeting goals or deadlines.
• Maintain a high level of integrity while balancing multiple priorities and responsibilities.

Responsibilities

• 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.

Benefits

• You will join a team focused on quality and patient safety.
• You will gain exposure to supplier relationships, laboratory workflows, and regulatory readiness.
• We support development through training, mentoring, and opportunities to lead improvement projects.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees