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 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.

Work Arrangement
This position is on-site to support laboratory and material handling activities. Some roles may offer occasional hybrid flexibility with manager approval, but the primary expectation is presence at the laboratory site. Position may require employees to work in a rotational schedule.  This schedule may include holidays, and weekends; overtime may be required.

What you can expect working with us
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. If you bring curiosity, accountability, and a willingness to learn, you will thrive here.

Apply now to be part of a team that helps deliver safe, quality outcomes and contributes to GSK’s mission to get ahead of disease together. We look forward to learning about what you can bring to the role.

#LI-GSK

#MariettaGSC

#GSKMarietta

#Global supplychain

Please visit  GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the appropriate Recruitment Staff by emailing us at - usrecruitment.adjustments@gsk.com

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/