QS-21 Manufacturing Associate - Hamilton, United States - GlaxoSmithKline

Description

Site Name: USA - Montana - Hamilton
Posted Date: Mar

The QS-21 Manufacturing Associate will support the start-up, definition of procedures, manufacturing of consistency batches, and sustained production of QS-21. This includes seeing a batch from raw materials to final shipped product, including, manual manipulations, automated manufacturing, cleaning of the facility, and review batch records.

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

• Support and promote the overall site goal of Safety First.
• Responsible for application of GSK safety and environmental guidelines and act as a role model within the department.
• Ensure all job responsibilities adhere with applicable regulations, current operating procedures and industry practice.
• Identify and help mitigate EHS and safety risks.
• Working with technical production equipment (e.g. HPLC and Lyophilizer). This includes interfacing with DeltaV automation to run the production equipment.
• Lead/support validation related to equipment, cleaning, and manufacturing processes Experience and competence in troubleshooting equipment and automation
• Perform manual operations including set-up/breakdown of filtration skids, filling/loading of lyophilization trays, loading equipment for cleaning, and routine sampling.
• Adherence to Good Documentation Practices as part of batch execution.
• Ability to take ownership and accountability of their process/batch as they see it from raw material through final bulk packaging.
• Excellent communication skills (written and verbal) within the team and across departments.
• Supports cross-functional communication and the GSK quality mindset by proactively identifying and reporting compliance issues to area supervisor and QA.
• Actively participate in a high performing team, able to demonstrate initiative.
• Ability to collaborate as part of a team and effectively work across boundaries including coordination with different departments.
• Drafting and revising Standard Operating Procedures.
• Drafting and leading Change Controls for modifications to the procedures and processes.
• Deviation writing, including root cause investigation and corrective action creation.
• Perform and monitor manufacturing processes using a highly automated approach based upon Emerson's Delta V platform.
• Troubleshoot process deviations resulting from automation communication issues.
• Assemble batch reports using Emerson Delta V and OSI PI historian.
• Ability and drive to work independently toward completion of objectives per schedule.
• Ensure all activities are executed following Quality and regulatory standards.
• Participate in and support continuous improvement and performance management initiatives.
• Drive and support GPS (GSK Production System) principles and initiatives.
• Demonstrate a continuous improvement mindset to drive business impact.
• Adhere to GSK values and expectations including: Patient Focus, Transparency, Respect, Integrity, Courage, Accountability, Development, and Teamwork.
• Represent GSK with the highest level of integrity and professionalism.
• Ability to maintain confidentiality of sensitive information.
• Adhere to GSK policies and procedures and support management decisions and goals in a professional manner.
• Show awareness of changing schedules, request and priorities put forth by management.
• Adhere to GSK policies, procedures and support site goals.
• Participate in and support continuous improvement and performance management initiatives.
• Recognize technical issues and relay to supervisor. Perform duties as assigned with respect to quality, timeliness, quantity and cost.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Highschool Diploma/GED and 4+ years of cGMP/healthcare/lab related experience OR Bachelor's Degree and 1+ years of cGMP/healthcare/lab related experience

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Bachelor's degree or some post-secondary education (including math, science, or technical writing)
• Good verbal and written communication skills.
• Ability to communicate effectively and project a professional image when giving/taking information in person, in writing, or over the phone.
• Understanding of Microsoft Office (MS Word, MS Excel, MS Outlook).
• Understanding of weights and volume measures.

#LI-GSK

#LI-Onsite

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

Why Us?

GSK is 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 organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at US Toll Free) or outside US).

GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

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