QC Specialist

1 month ago

King of Prussia, Pennsylvania, United States GlaxoSmithKline Full time
Site Name: USA - Pennsylvania - King of Prussia
Posted Date: Aug 6 2024

Are you interested in working with cutting-edge laboratory technology to improve quality and accelerate regulatory compliance? If so, this Quality Control role could be an exciting opportunity to explore.

The Quality Control Specialist develops and implements programs and metrics to establish and maintain quality standards of existing products, and internal systems and processes. Authors policies, procedures and reports to monitor products, materials, components and/or operational quality activities and quantifiably measure improvements.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
  • Provide input into the effective analytical planning and scheduling of testing, maintenance, and any other manufacturing process impacting activities in the building.
  • Initiates Deviations as needed and facilitates investigation.
  • Creates, monitors and reports quality metrics.
  • Identifies optimization opportunities in Quality Control by owning Change controls and CAPA tracking.
  • Author or revise documents for compliance, accuracy and clarity.
  • Performs review of analytical data to support batch release and CoA/ RoA creation.
  • Familiar with Data integrity principles and looks for improvements to eliminate or reduce DI issues.
  • Supports implementation of new products in the facility (BAU process and Data maintenance)
  • Performs routine departmental GMP activities (audit support, regulatory requests, etc. ).
  • Share solutions across GSK network, as applicable.


Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:
  • Bachelor of Science
  • 5+ years manufacturing experience
  • Experience in the pharmaceutical or biotechnology industry
  • SAP/ERP experience
  • MS Office experience


Preferred Qualifications:

If you have the following characteristics, it would be a plus:
  • Master's degree
  • Digital tools experience such as PowerBI
  • Experience with lab metrics and KPIs
  • Strong Leadership skills
  • Strong communication skills
  • Strong understanding of cGMP Lead change projects with compliance in mind
  • Applying ALCOA principles when performing operations or reviewing analytical data
  • Ability to work independently as well as being able to work collaboratively with others on projects
  • Experience with various systems such as: SAP, LES, Empower, BI reports, Root cause analysis and EDM
  • Trend analysis experience


#LI-GSK

Please visit GSK US Benefits Summary t o 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 US Toll Free) or 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.

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