QC Data Reviewer

3 weeks ago


Lexington, United States Integrated Resources, Inc ( IRI ) Full time

Job Description:

Must haves:

  • Experience being responsible for quality control of all scientific data generated within the Nonclinical Pharmacology group.
  • Familiarity with Bioanalytical sample and data analysis
  • Attention to detail and experience with raw data QC.


Summary:

  • This position is responsible for the quality control of all nonGLP data generated in the Nonclinical Pharmacology group within GNAT unit.
  • Key Responsibilities:
  • Work closely with scientists within the ADME group to verify bioanalytical data generated using HPLC-FD and LC-MS/MS.
  • Work closely with scientists within the in-vivo pharmacology group to verify in-vivo and Pharmacodynamic (qPCR) data.
  • Review and verify all data to ensure accuracy, completeness, and compliance with internal guidelines and acceptance criteria.
  • Generate reports/checklist for all QC findings, along with subsequent discussions with relevant scientists in order to resolve issues.
  • Interpret data and provide insight for in-vivo studies, ensuring alignment with study objectives and protocols.
  • Collaborate with cross-functional teams to support raw data verification.
  • Ensure data integrity and quality by adhering to internal and other regulatory guidelines. .
  • Enhance QC initiatives through the identification and implementation of best practices in data review and analysis.


Qualifications:

  • Strong analytical skills with a keen eye for detail.
  • Familiarity with analytical software’s.
  • Familiarity with regulatory guidelines and standards related to bioanalytical data review.
  • Excellent communication and collaboration skills.
  • Experience:
  • Prior experience in quality control of Scientific data.
  • Minimum of 1 year experience with data review/QC, preferred 3-5 years of experience.
  • Education:
  • A degree in a relevant scientific discipline, such as Biochemistry, Biotechnology, Pharmacology, or related fields


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