GSK
QS-21 Manufacturing Associate
GSK
Hamilton, MT
Aug 25, 2024
unknown
Full Job Description
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

#EarlyCareers

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 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. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

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.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (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.

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 GSK’s Transparency Reporting For the Record site.

PDN-9cd2f515-6468-4506-9e22-8612b93688a6
Job Information
Job Category:
Manufacturing
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QS-21 Manufacturing Associate
GSK
Hamilton, MT
Aug 25, 2024
unknown
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