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Quality Oversight Specialist
Job in
Irvine, Orange County, California, 92713, USA
Listed on 2026-06-18
Listing for:
GlaxoSmithKline
Full Time
position Listed on 2026-06-18
Job specializations:
-
Quality Assurance - QA/QC
Data Analyst
Job Description & How to Apply Below
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 To ensure adherence to GMP standards and procedures through independent oversight of GMP processes. To improve the effectiveness of quality in preventing, identifying and addressing quality issues by encouraging proactive quality culture and continuous improvement. To maintain shift based presence and be accountable for key quality decision-making or quality escalations. To provide first line support to operational areas (for example: rapid response to quality issues, provide guidance and coaching) and maintain inspection-readiness through independent checks.
Responsibilities This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
Ensure that all GMP processes and operational personnel adhere to current local or area specific procedures, minimising risk of non-compliance and always maintaining inspection readiness.
Maintain presence across area of responsibility and be the first line of contact to support initial management of quality issues and be accountable for key quality decision making across activities such as the initial impact assessment for deviations. Provide guidance during GMP activities to proactively detect potential quality issues through active observation in real-time, allowing for timely interventions to prevent deviations and defects
Provide Quality support for site Management monitoring audits across GMP areas.
Ensure adherence to frequency of oversight mandated in the Quality oversight schedule.
Check that facilities are being maintained in a good state in line with local housekeeping standards and any deviation from the standards are escalated with associated actions addressed within a timely manner.
Role model the GPS standards for example participating through tiered accountability meetings (for example, production change over meetings).Foster a Quality Starts With Me (QSWM) culture by providing coaching to employees on the importance of following procedures, doing the right thing and explaining the why and the impact non compliance can have on product quality and patient safety.
Out of hours support for SLE process confirmation of non-routine or high-risk activities.
Why You?
Basic Qualification We are seeking professionals with the following required skills and qualifications to help us achieve our goals:
Degree, HND/HNC or equivalent in a life science, chemistry, microbiology or related subject, or substantial practical laboratory experience.
Experience of the pharmaceutical industry, excellent working knowledge of QMS / GMP and the related manufacturing aspects / experience in resolving cGMP issues.
Strong influencing, communication and coaching skills. Ability to effectively contribute to Department project activities.
Preferred Qualification If you have the following characteristics, it would be a plus:
Familiarity with investigation tools and managing CAPA processes.
Proven experience preparing for audits and inspections.
Prior experience in on-site pharmaceutical manufacturing.
Working Pattern This role is on-site s is a shift-based role; exact shift patterns will be discussed during the recruitment process.
Inclusion We welcome…
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