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
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.
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.
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