Quality Control Data Reviewer

GlaxoSmithKline • King of Prussia, PA

393d

About The Position

As a Quality Control Data Reviewer at GSK, you will be responsible for performing technical reviews of analytical data across various testing areas, including Biochemistry, Microbiology, and Raw Materials. This role is crucial for ensuring the accuracy and compliance of laboratory data to support product release and stability testing. You will also have the opportunity to lead audits, train team members, and identify continuous improvement opportunities within the data flow process.

Requirements

• Bachelor's Degree
• 3+ years of experience in the Biopharmaceutical/pharmaceutical industry
• Experience in quality control
• Experience with ALCOA principles

Nice To Haves

• Attention to detail
• Working knowledge of cGXP, Data integrity, ALCOA principles
• System experience preferred- SAP/ERP, LES, Webstatistica, Empower, Hamilton
• Analytical experience preferred (e.g Separations- such as CGE/CE-SDS/HPLC/cIEF, Immunoassay- ELISA/qPCR/SPR/Bioassay, Compendia and/or Microbiology-Bioburden/Endotoxin)
• Experience using Excel, Word and Powerpoint
• Strong organizational and task management skills
• Strong leadership skills
• Strong data analysis, data trending and communication skills
• Ability to work independently or as part of a team with minimal supervision

Responsibilities

• 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.

Benefits

• Comprehensive benefits program
• Opportunities for career growth
• Supportive work environment
• Diversity and inclusion initiatives

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree