QC Data Reviewer

Posted:
8/11/2024, 5:00:00 PM

Location(s):
Upper Merion Township, United States

Experience Level(s):
Junior ⋅ Mid Level

Field(s):
Data & Analytics

The QC Data Reviewer will perform a technical review of analytical data for Biochemistry, Microbiology, Raw Materials and Compendial testing to support release, stability and tech transfer testing.

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

  • Review and approve laboratory data using the ALCOA principles 

  • Ensure release and stability data is performed on schedule to support batch release 

  • Train other data reviewers to increase capabilities of the team 

  • Assist with sample management upon completion of data approval 

  • Support or Lead Level 1 Audits and Deviation Investigations 

  • Archive Data per local procedures 

  • Participate in regulatory audits as an SME in the data review process 

  • Identify and lead continuous improvements around the data flow process  

  • Review and/or transcribe stability and external party data 

  • Author or revise documents for compliance, accuracy and clarity 

Why you? 

Basic Qualifications: 

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

  • Bachelor of Science 

  • 2+ years’ laboratory experience in a GMP environment 

Preferred Qualifications: 

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

  • Attention to detail 

  • Working knowledge of cGXP, Data integrity, ALCOA principles 

  • System experience preferred- SAP/ERP, LES, Webstatistica, Empower, various lab software 

  • Analytical experience preferred (e.g separations- such as HPLC,cIEF, Immunoassay- ELISA, qPCR, SPR and/or Microbiology-Bioburden/Endotoxin )  

  • Experience using Excel, Word and PowerPoint 

  • Strong organizational and task management skills 

Please visit  GSK US Benefits Summary to 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 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (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.

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Glaxosmithkline Plc

Website: https://gsk.com/

Headquarter Location: London, England, United Kingdom

Employee Count: 10001+

Year Founded: 1929

IPO Status: Public

Last Funding Type: Grant

Industries: Biotechnology ⋅ Health Care ⋅ Pharmaceutical