QC Data Review Specialist

3 weeks ago


Irving, Texas, United States Medisca Full time
Job Title: QC Data Reviewer

CED Analytics, a Medisca Partner, is seeking a highly skilled QC Data Reviewer to join our team. As a QC Data Reviewer, you will play a critical role in ensuring the accuracy and quality of laboratory data, including routine QC testing and stability study testing.

Responsibilities:
  • Perform data review on all types of analytical testing, including identification testing, wet bench testing, titration, HPLC, GC, ICP-MS, etc.
  • Verify all laboratory notebooks and associated printouts for correctness of raw data and ensure all reagents, standards, and equipment used are within acceptable limits.
  • Work with analysts to ensure timely document corrections and provide guidance on documentation requirements as needed.
  • Notify Quality management of any out-of-specification results and provide support in the investigation process as needed.
  • Ensure all data is reviewed quickly and accurately according to laboratory SOPs.
  • Generate Certificates of Analysis for completed routine testing.
Requirements:
  • Bachelor of Science in Chemistry or a Science-related field.
  • Minimum of three (3) years of experience in a pharmaceutical environment/cGMP laboratory.
  • Two (2) - three (3) years in Quality Control.
  • Experience with reviewing all forms of Analytical Chemistry Data.
  • Strong working knowledge of cGMP/GLP, USP/NF, ICH, and FDA regulations.
  • Experience working with a Laboratory management system (LIMS) preferred, but not required.
  • Knowledge of Microsoft Office suite (Word, Outlook, Teams, and Excel).
  • Excellent communication skills; fluent English (oral & written) required.
  • Able to work independently and with minimal supervision.
  • Strong organizational skills, ability to prioritize multiple projects, detail-oriented.
What We Offer:
  • Work/Life Balance - PTO, vacation policy, and paid statutory holidays.
  • Invest in your health - Group Benefit plan and health savings account.
  • Your well-being is important - Wellness program offered.
  • Your Future is Bright - Opportunities to learn and grow within CED.
  • Save for your Future - CED contributes to a 401k plan when you invest in the plan.
  • Help us grow - Employee Referral Program.
  • We like to have fun - company events throughout the year.

We thank all applicants for their interest; however, only candidates to be interviewed will be contacted. We are an equal opportunity employer.



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