Site Name: USA - Maryland - Rockville
Posted Date: Feb 3 2023

Are you looking to enhance your technical capability by working in a global manufacturing environment that allows you to leverage best in class systems and technologies? If so, this Production Specialist role could be an ideal opportunity to explore.

Reporting into the Specialist team, the role will assist with execution of the production schedule by troubleshooting and remediating operational and process issues, executing root cause investigations, owning/authoring deviations and other quality report types, and revising GMP documents such as SOPs and Manufacturing batch records.

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

• Initiates Quality Records and conducts deviation investigations.

• Leads or assists in investigations including root cause analysis and assesses product impact using input from various departments

• Develops, executes and oversees CAPAs

• Supports Tech transfer and process monitoring support as needed

• Works with the team to monitor critical process parameters

• Revision and management of manufacturing documents such as Batch Records and SOPs

• Leads or supports Continuous Improvement projects

• Conducts data gathering, trending, and data presentation as needed to support investigations

• Supports Manufacturing coordination efforts such as sampling, equipment modification and maintenance, and internal inspection activities to ensure minimal interruption to routine operations

• Assists with shutdown/changeover and campaign scheduling and schedule management

• Support internal and external audits as needed

Why you?

Basic Qualifications:

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

• Bachelor’s degree in a scientific or technical discipline
• 2+ years of GMP experience working with Batch Records or SOP's

Preferred Qualifications:

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

• Demonstrated ability to work effectively cross-functionally, lead teams and implement project plans on time and on budget

• Excellent communication and technical writing skills

• Ability to support and/or lead system troubleshooting efforts

• Initiates change control for equipment modifications

• Assist with coordination of cleaning validation and verification activities in the manufacturing areas to ensure minimal interruption to routine operations

• Assist in development, execution and reporting of data from biopharmaceutical technology and tech transfer studies/protocols

• Participate in cross-functional teams to solve production problems

• Must be willing to work shifts

• Ability to collect, assess, and generate and depict conclusions from large quantities of production data

Why GSK?

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 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 Get Ahead Together.

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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. 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 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.

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