Overview
Quality Control Lead Jobs in Massachusetts, United States at Integration International Inc.
Title: Quality Control Lead
Company: Integration International Inc.
Location: Massachusetts, United States
Job Title: Non-Clinical Quality Control Reviewer II
Duration: 06-12 months contract
Pay Rate: $50 – $55/hr on W2
Key Responsibilities:
QC of nonclinical documentation: Reviewing raw data, study reports, and regulatory summaries for accuracy, completeness, and compliance.
Collaboration: Work closely with medical writing, toxicology, bioanalytical, pharmacology, and research teams to ensure documents meet regulatory and internal standards.
Data Verification: Specifically verifying bioanalytical data (HPLC-FD, LC-MS/MS systems, qPCR) for consistency and alignment with internal guidelines.
Must-Have Skills/Experience:
QC Experience: Previous experience performing quality control of nonclinical study documentation.
Technical Knowledge: Familiarity with bioanalysis, pharmacokinetics, pharmacology test systems, and software (e.g., HPLC-FD, LC-MS/MS, GraphPad Prism).
Detail-Oriented & Analytical: Strong attention to detail and ability to assess complex data.
Qualifications:
Education: Minimum of a bachelor’s degree in a life science discipline.
Experience: 3+ years in a pharmaceutical or biotechnology setting.
Technical Proficiency: Familiar with FDA/ICH guidelines, lab-based analytical software, and MS Office (Word, Excel).
Communication: Strong written and verbal English communication skills.
Organizational Skills: Ability to meet deadlines and manage multiple reviews efficiently.
