MAPS Stability Coordinator

Job description

Nombre del sítio: USA - Pennsylvania - Marietta
Fecha de publicación: Feb 22 2024

Are you interested in working with cutting-edge laboratory technology to create and manage a stability program?  If so, this Stability Coordinator role could be an exciting opportunity to explore.

The Stability Coordinator owns the Stability Coordination program and processes for QC, including: Creation of new material numbers for required sample types as well as inspection plans for testing to be applied. 

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

·  Drive a strong safety culture within QC and the site. Adhere to established EHS policies and procedures.
·  Owns product Stability program: planning, implementation, execution, updates, and execution of tasks including: (Pulling the samples, scheduling and managing testing, approval of results and UD’s)
·  Generating stability and trending reports
·  Creating new stability plans in SAP
·  Master data updates associated with creating and maintaining stability inspection plans
·  Creating and maintaining the Stability Calendar
·  Working with Manufacturing to acquire samples for stability studies
·  Writing and circulating non-routine stability study protocols and final reports.
·  Working with Regulatory Affairs and the global team to comply with filing requirements and global requests.
·  Interact with global stability team
·  Generate annual PQR(s)
·  Owner of stability LSOP’s and alignment with VSOP. 
·  Represent the stability program as an SME during internal/external audits.
·  Escalate stability issues/concerns to management
·  Drive purchase, implementation, and management of stability storage chambers
·  Management of Stability program retention program

Why you?

Basic Qualifications:

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

·  ​B.S or B.A in Microbiology, Biochemistry, or a related scientific discipline. 
·  Degree in other discipline a minimum of 3+ years of experience in stability plan creation and management or sample management
·  Minimum of 3 years experience in cGMP-regulated environment.
·  Minimum of 2 years' previous experience with LIMs, SAP, and stability planning/management is required.

Preferred Qualifications:

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

·  Working knowledge of pharmaceutical facilities, equipment and systems, including a technical understanding of industry and science practices related to the business in order to apply knowledge to daily activities.
·  Knowledge of GMP’s, NIH Guidelines, FDA and other regulatory agency requirements sufficient to apply to quality operations, stability, and compliance.
·  The ability to communicate both verbally and in writing with all levels both inside and outside of the organization. 
·  The ability to clearly write technical documentation as necessitated by regulatory agencies and internal policy.
·  Ability to establish and maintain working relationships with staff and the ability to analyze data and implement changes. 
·  Must have an aptitude for facilitating a team environment and working independently toward the goal of completing stability planning and implementing required stability sampling and testing.
·  Participate in cross-functional deviations as needed.
·  Must have strong technical writing skills.

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 .

#GSKMarietta

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Please visit  GSK US Benefits Summary to 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.

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