Job Information
GlaxoSmithKline Consumer Healthcare, L.P. QC Sterility Assurance Specialist in Hamilton, Montana
Site Name: USA - Montana - Hamilton
Posted Date: Nov 28 2022
As a QC Sterility Assurance Specialist, you will provide support and expertise for site regarding contamination control of the processes and facility under the scope of sterility assurance. In this role, you will ensure that the site is continuously compliant with sterility assurance regulatory expectations for the level required by the manufacturing processes.
The QC Sterility Assurance Specialistwill provide support and expertise to operations to ensure that site applies all Sterility Assurance processes applicable to bioburden controlled manufacturing (e.g. including Material transfer, Gowning, Environmental Monitoring, Cleaning and disinfection, Sanitization, and Clean Utilities) to confidently deliver products to patients with the highest sterility assurance level required at an appropriate cost.
GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by the state or local law and where vaccine supply is readily available. GSK employees working in Montana are excluded from the Company mandate per House Bill 702.
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
Serving as a leader within the team and as a technical expert for the team and site. Training in sample execution and data systems necessary.
Knowledgeable of maintenance and use of EMSM SAP module and master data, sampling programs, risks, compliance requirements, and processes at the site.
Provides leadership to complex investigations, trouble-shooting equipment and sampling, preparation/execution of validation/qualification protocols, and LSOP revision/review.
Document management/ownership and review for documents covered by Sterility Assurance
Perform non-routine tests, studies or projects and communicate results to key customers.
Lead the qualification, operation and schedule for projects required within the team scope of work. Escalate issues as required.
Author and/or execute Change Control, Deviation, CAPA documents/tasks, and lab investigations (EHS, Deviation, AR, OOS, etc.) as necessary.
Support the Quality Management Systems through gap analysis and return to compliance tasks for GSK expectations and external regulatory requirements.
Understand and comply with current GMP regulations and quality systems. Promotes a quality mindset in every action, every day by routinely communicating concerns, issues and best practices.
Accountable for supporting QC and site operations, communicating in a positive, professional manner, supporting operational excellence principles and supporting and implementing management decisions.
Responsible for application of GSK safety and environmental guidelines and identification, escalation and prevention of safety issues.
Maintain area of responsibility in a state of inspection readiness and perform self-inspections.
Provide support for global initiatives such as Data Integrity and LES.
Performs other departmental duties as assigned by management.
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
Bachelor's Degree in any discipline
Physical requirements include stooping, standing, climbing and occasional lifting of up to 50 lbs
Preferred Qualifications:
Bachelor's Degree in a scientific discipline.
cGMP industry experience.
Excellent written and verbal communication skills.
Proficient in standard MS software including Word, Excel, PowerPoint, Teams.
SAP and Project Management experience.
In depth knowledge of regulations, guidance, best practices and industry standards related to sterility assurance (for example: GSK, GMP, WHO, PDA, ASTM, ISPE, PhRMA, etc.) including review of regulatory files.
Demonstrated ability to work successfully both independently and in a team environment.
Excellent time management skills.
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Why GSK?
At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Health, strengthening our leadership, and transforming our commercial execution. Now, we're making the biggest changes we've made to our business in over 20 years. We're on track to separate and create two new companies in 2022: New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands.
With new ambition comes new purpose. For New GSK, this is to unite science, talent and technology to get ahead of disease together - all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive.
Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that is ambitious for patients - so we deliver what matters better and faster; accountable for impact - with clear ownership of goals and support to succeed; and where we do the right thing. So, if you're ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead 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. 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.
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).
At GSK, the health and safety of our employees are of paramount importance. As a science-led healthcare company on a mission to get ahead of disease together, we believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve.
GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. The only exceptions to this requirement are employees who are approved for an accommodation for religious, medical or disability-related reasons.
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