Associate Site Investigation Specialist

GlaxoSmithKline plc; Upper Merion Township (Montgomery County); On-site; USD 65,000 - 90,000; Full time

Job summary

GlaxoSmithKline plc is seeking an Associate Site Investigation Specialist for a 5-day on-site role at a US manufacturing or laboratory site. You will act as the lead investigator for deviations, perform root-cause analysis, and develop CAPAs in alignment with GSK standards.

The role requires a GMP-regulated manufacturing background (1+ year) and Orange Belt certification. You will collaborate with QA, engineering and production teams and ensure documentation adheres to ALCOA principles.

Qualifications

• Bachelor of Arts or Bachelor of Science.
• 1+ years of experience in a GMP-regulated manufacturing environment or related industry, with experience executing production processes, supporting manufacturing operations, adhering to quality and compliance requirements, and performing assigned technical or operational tasks.
• Orange Belt Certification will be required to successfully perform the role.

Responsibilities

• Lead Investigator for deviations using standardized processes and training.
• Apply DMAIC and GPS tools to improve efficiency and prevent non-compliance.
• Investigate deviations, non-conformances and quality events, collecting and analyzing data.
• Identify root causes and implement CAPAs.
• Collaborate with cross-functional teams to gather information and support CAPA implementation.
• Prepare investigation reports documenting findings, root causes and CAPAs.
• Act as expert in VQMS for tracking, managing, and documenting investigations and provide training.
• Deliver training on investigation processes and root cause analysis techniques.
• Adhere to ALCOA principles for documentation.
• Own deviation and environmental monitoring investigations, write-ups, CAPA management, impact assessments, and simple change controls.

Skills

Bioprocessing

Cell Line Development

Experimental Methods

Technical Writing

Technology Transfer

Education

Bachelor of Arts or Bachelor of Science.

Bachelors of Science, Engineering or Biotechnology.

Job description

Job Title

Associate Site Investigation Specialist

Job Purpose

The Associate Site Investigation Specialist is responsible for identifying and analyzing non-conformances to determine their root causes and develop corrective and preventive actions (CAPA) in alignment with GSK Global Standards. This role is critical in ensuring product quality, patient safety, regulatory compliance, and maintaining the facility’s License to Operate. The specialist acts as a key contributor in upholding the integrity of manufacturing processes and the reliability of product outcomes.

Key Responsibilities

• Serve as the Lead Investigator for deviations by utilizing the standardized processes learned and completed through the GSK Orange Belt Training and Certification program.
• Utilize DMAIC (Define, Measure, Analyse, Improve, Control) problem-solving and GSK Production System (GPS) tools to improve efficiency, eliminate waste, and prevent non-compliance events.
• Conduct thorough and timely investigations of deviations, non-conformances, and other quality events, ensuring all relevant information is collected and analyzed.
• Utilize appropriate problem-solving tools and techniques to identify root causes and implement effective corrective and preventive actions (CAPAs).
• Collaborate with cross-functional teams such as production, quality assurance, quality control, engineering, labs, and warehouse to gather information and support the implementation of CAPAs.
• Prepare comprehensive investigation reports documenting findings, root causes, and CAPAs with accuracy and compliance to regulatory and internal standards.
• Serve as an expert in the Validated Quality Management System (VQMS) for tracking, managing, and documenting investigations, while providing training and support for effective system utilization.
• Deliver training and guidance to personnel on investigation processes, root cause analysis techniques, and deviation management to foster a quality-focused culture.
• Adhere to ALCOA principles (Attributable, Legible, Contemporaneous, Original, Accurate) for all documentation tasks.
• Own deviation and environmental monitoring investigations, write-ups, corrective and preventive action management, impact assessments, and simple change controls.

Basic Qualifications

• Bachelor of Arts or Bachelor of Science.
• 1+ years of experience in a GMP-regulated manufacturing environment or related industry, with experience executing production processes, supporting manufacturing operations, adhering to quality and compliance requirements, and performing assigned technical or operational tasks.

Preferred Qualifications

• Bachelors of Science, Engineering or Biotechnology.
• Orange Belt Certification will be required to successfully perform the role.

Work Arrangements

This role is 5 days on-site at a GSK manufacturing or laboratory site in the United States.

Closing Date for Applications

25/11/2026

Skills

• Bioprocessing
• Cell Line Development
• Experimental Methods
• Technical Writing
• Technology Transfer

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

Why GSK?

Unifying 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.

Equal Opportunity

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/

We are a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. Find out more on our career site.