GlaxoSmithKline Consumer Healthcare, L.P. QC Systems Support Specialist in Hamilton, Montana
Site Name: USA - Montana - Hamilton
Posted Date: Nov 9 2022
As a QC Systems Support Specialist, you will manage non-testing laboratory support systems and processes for QC, including: Maintaining SAP Modules, Master Data/Monograph Creation, Compendial Review, Equipment Qualification/Lifecycle, and Method Validation/Transfer.
In this role, you will serve as a Lead Investigator for select QC Unplanned Events, as well as change coordinator for selected QC Change Controls. In addition, you will author QC Technical Documents, such as validation and trend reports and provide data for annual PQR.
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:
Provides leadership to complex lab investigations, trouble-shooting equipment and assays, preparation/execution of validation/qualification protocols, LSOP revision/review and the resolution of complex lab investigations.
Perform non-routine tests, studies or projects and communicate results to key customers.
Lead the qualification, operation and scheduled maintenance of laboratory equipment, including automated and computerized systems and assure they remain in a functional, validated state. Escalate issues associated with equipment and assays as required.
Author and/or execute Change Control, Deviation, CAPA documents and lab investigations (EHS, Deviation, AR, OOS, etc.) as necessary.
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.
Lead risk assessments (CRA, WRA, etc.) and propose departmental risks. Duties may include minimal handling of hazardous waste from laboratory activities to satellite storage areas. This training satisfies annual RCRA training requirement for large quantity generators and is part of the site's RCRA compliance program.
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.
We are looking for professionals with these required skills to achieve our goals:
1+ years of experience in laboratory or research environment
Bachelor's Degree in a scientific discipline
Experience with life sciences in a cGMP environment
Proficient in standard MS software including Word, Excel, PowerPoint, and Teams
Experience with Change Control and Project Management
Demonstrate ability to work successfully both independently and in a team environment
Good verbal and written communication skills
Good time management skills
Good attention to detail and must be a self starter
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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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.