Business Introduction
At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together.
Find out more:
Our approach to R&D
Position Summary
You will produce clinical trial materials (CTM) for domestic and international clinical trials. You will be responsible for performing label printing/inspection and documentation preparation activities to meet the required GMP quality standards.
Responsibilities
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
Must assure clinical trial materials (CTMs) are produced in accordance with packaging orders to achieve useful results. CTMs are produced in compliance with applicable regulations.
Identifies problems and deviations, and makes recommendations on solutions to ensure deadlines are met. Does not perform final verification/quality critical checks unless trained to perform a specific check.
Print and inspect clinical labels for use in clinical trials including bay set-up and line clearance.
Prepare data entry for primary or secondary packaging documentation in accordance with GMPs and Standard Operating Procedures
Ensure high levels of attention to detail and data accuracy to documentation
Use systems that are critical to the delivery of labels and packaging documentation (e.g. ClinPro, PTMS, COMET, or future applicable systems), recognize when it is necessary to seek support to resolve systems issues
Ensure routine tasks (i.e. Print head checks) are performed in accordance with their required schedule
Executes assigned tasks and activities with high quality and attention to own and other’s safety
Ensure that any non-standard activities that occur during label or documentation preparation are appropriately raised to team coordinator or supervisor (e.g. Deviations)
Acts as first line resolution of quality, productivity , and safety issues.
Verify equipment set up including quality critical settings.
Complete and verify reconciliations of labels
Anticipates/recognizes potential problems with equipment/materials and initiates action to address or prevent problems.
Identifies and begins to interpret problems in processes and/or in results and communicates them to his/her supervisor
Consults with supervisor when difficulties arise that cannot be readily resolved
Work with trainees to complete training modules and assess training competency of specific activities.
Participate in safety risk assessments.
Identify and participate in delivery of continuous improvement opportunities in order to improve quality, productivity, and safety.
Responsible for requesting labels for the on-time completion of jobs
Participate in Quality Investigations as a technical expert in a manner subject to L2/L3/L4 scrutiny, when appropriate
Participate in local and regulatory audits (compliance and safety).
Write and obtain approval of observation reports
Learning to present concise summaries of own activities in group settings
Participate on inter-department project teams to meet company milestones and objectives
Prepares brief oral or written summaries of results with interpretation for “projects”
Assist in primary and secondary packaging floor operations as needed (with appropriate training)
Development of expertise in label printing and inspection and document creation
Why You?
Work model: This role is on-site and the work shift is 6:30 am-3:30 pm on Monday through Thursday and 6:30 am to 12 pm on Friday.
Basic Qualification
We are seeking professionals with the following required skills and qualifications to help us achieve our goals:
High school diploma or equivalent, Bachelor's d egree in STEM preferred
Experience with GMPs (current Good Manufacturing Practice) and other applicable regulatory requirements for Packaging and Labeling
Experience with the development process and experience in the clinical supplies area
Experience with GMP label creation and packaging operations to support clinical trials
Experience with basic PC operation (Email, Windows, word processing, database, spreadsheet applications) and resolving issues in validated systems
Technical writing experience with documents for Deviation, CAPA and SOP updates
Preferred Qualification
If you have the following characteristics, it would be a plus:
Previous leadership/supervisor people management experience
Ability to work independently with minimal supervision.
Ability to prioritize tasks and work in a flexible manner with some supervisory input
Should be detail oriented
Good interpersonal skills
Ability to adhere to written instructions (i.e. follow the rules and guidelines of the department)
Develop sound judgment, decision-making skills and strong organizational skills and beginning to influence others
Must exhibit strong communication, negotiation, and interpersonal skills
Ability to function on a high performance team
Ability to listen and follow verbal instructions
Ability to perform trouble shooting and problem solving with supervision
Ability to follow-up and evaluate problems appropriately
Ability to double-check the work of others for accuracy
Ability to build team spirit
Participate and support implementation of change
#GSK-LI
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 - [email protected]
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.
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