Gsk

Operational Quality Specialist

USA - North Carolina - Zebulon

Sponsorship not specifiedDetected 6 days ago

ComplianceSupply ChainProcurementHRRoboticsGMPCommunicationProblem SolvingWritingGxP

About the role

You will provide operational quality oversight on site to help ensure safe, compliant and reliable supply.
You will work closely with production, laboratories, engineering and quality teams.
We value practical problem solvers who make clear decisions, coach others, and act with integrity.

Maintain presence across area of responsibility and be the first line of contact to support initial management of quality issues.
Provide on‑the‑floor quality oversight, perform regular shopfloor walk‑throughs, and detect early quality risks.
Approve or recommend disposition decisions and support lot release activities under defined procedures.
Support and perform self‑inspections, internal audits, and inspection readiness activities.
Ensuring GMP documentation and records follow Good Documentation Practice (GDP) by adhering to principles for data integrity through both review and end-user support.
Perform a spot-check of activities across defined GMP areas to ensure compliance with quality standards that includes production, testing, cleaning and maintenance activities.
Collaborate with cross-functional teams to resolve quality issues, implement corrective/preventive actions (CAPAs) and support continuous improvement efforts.
This role will provide YOU the opportunity to lead key activities to progress YOUR career.
We manufacture and supply reliable, high-quality medicines and vaccines to meet patients' needs and drive our performance.
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.

Bachelor's degree in a scientific, engineering, or technical discipline
2+ years of experience in a regulated life sciences manufacturing or quality role.
1+ year of experience with Good Manufacturing Practices (GMP) and good documentation practices.
1+ year of experience reviewing batch records and GMP documentation.
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.

If you have the following characteristics, it would be a plus:
Experience in biologics or pharmaceutical manufacturing environments.
Experience with deviations, CAPA, change control, and validation activities.
Training or experience in root cause analysis methods such as DMAIC or similar.
Familiarity with inspection readiness and regulatory agency expectations.
Ability to influence cross‑functional teams and coach others on quality behavior.
Comfort working in a fast‑paced environment and prioritizing competing demands.
Strong observational skills and the ability to make timely, clear quality decisions on the shopfloor.

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.
oncology
and infectious diseases - to impact health at scale.
Important notice to Employment businesses/ Agencies
GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together.
GSK is an Equal Opportunity Employer.
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site.
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/

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.
respiratory, immunology and inflammation; oncology; HIV; and infectious diseases - to impact health at scale.
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 focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases - to impact health at scale.

We are committed to inclusion and want people who will help create a respectful, supportive workplace.

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

This listing is sourced directly from Gsk's careers page and normalized into a canonical job model.