Non Clinical Quality Control Reviewer II

GForce Life Sciences; Lexington (MA); On-site; USD 50,000 - 113,000; Full time

Job summary

GForce Life Sciences is seeking a Non Clinical Quality Control Reviewer II for on-site work in Lexington, MA. The ideal candidate will conduct quality control reviews of nonclinical study documentation, ensuring compliance with FDA guidelines. Essential functions include data verification and collaboration with writing teams. Preferred qualifications include a life science degree and experience in a pharmaceutical setting.

Benefits

Medical insurance

Vision insurance

Qualifications

• Minimum 3 years experience in a pharmaceutical/biotechnology environment.
• Prior experience with quality control of data for scientific reports.
• Familiarity with FDA and ICH guidelines preferred.

Responsibilities

• Perform QC review of raw data generated by ADME team.
• Verify data for accuracy, completeness, and compliance.
• Work closely with teams to resolve inconsistencies.

Skills

Attention to detail

Analytical skills

Communication

Interpersonal skills

Education

Bachelor's degree in life science discipline

Tools

MS Office (Word, Excel)

GraphPad Prism

Lab-based analytical software

Job description

Non Clinical Quality Control Reviewer II

Non Clinical Quality Control Reviewer II

Get AI-powered advice on this job and more exclusive features.

Non-Clinical Quality Control Reviewer II

On-site in Lexington, MA

Must be able to work on a W2

TOP 3 MUST HAVES:

1. Experience with QC of nonclinical study documentation

2. Familiarity with bioanalysis, pharmacokinetics, and pharmacology test systems and software

3. Detail oriented with strong analytical skill set

PURPOSE/JOB DESCRIPTION:

This position will work closely with nonclinical medical writing, toxicology, bioanalytical, pharmacology, and research teams to conduct QC activities to support delivery of accurate, compliant, and submission-ready documents, including study reports and regulatory summaries.

ESSENTIAL FUNCTIONS:

• Perform QC review of raw data generated by ADME team, including bioanalytical data generated by HPLC-FD and LC-MS/MS systems and qPCR
• Verify data for accuracy, completeness, and compliance with internal guidelines
• Work with team to resolve inconsistencies
• Work closely with nonclinical writing team to provide QC review of reports and nonclinical regulatory content; ensure final documents adhere to internal procedures as well as FDA/ICH guidelines
• Complete reviews per established timelines

QUALIFICATIONS:

• Minimum bachelor's degree in life science discipline
• 3+ years experience in pharmaceutical/biotechnology environment
• Prior experience with quality control of data for scientific reports and regulatory submission con-tent
• Familiarity with FDA guidance and ICH guidelines preferred
• Critical attention to detail and strong organizational skills
• High degree of fluency with written English
• Excellent communication and interpersonal skills
• Proficiency with MS Office (Word, Excel), GraphPad Prism, and understanding of lab-based analytical software.

Seniority level

• Seniority level

  Associate

Employment type

• Employment type

  Contract

Job function

• Job function

  Analyst, Quality Assurance, and Science

• Industries

  Pharmaceutical Manufacturing

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Inferred from the description for this job

Medical insurance

Vision insurance

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