Quality Control Analyst IV Job at Meet Life Sciences, Cambridge, MA

dzA3R2tMeklOUnZ3azhGYTY5Ry9rYjM4eGc9PQ==
  • Meet Life Sciences
  • Cambridge, MA

Job Description

*W2 Only

Overview:

The Analyst IV is responsible for ensuring quality and compliance standards are met to support the commercialization of pharmaceutical/biotech programs. This role ensures completeness, consistency, and accuracy of regulatory filings, laboratory data, and reports through thorough review processes. This position offers remote flexibility with occasional on-site presence in Norton, MA, and Cambridge, MA, and potential travel to CMO/CTL sites.

Key Responsibilities:

  • Verify integrity and traceability of regulatory dossier sections against reference methods and reports.
  • Review analytical data for accuracy, completeness, and correct entries, including electronic data and laboratory documentation (notebooks, worksheets, logbooks).
  • Ensure complex notebooks for analytical method validation, verification, and transfer testing are compliant with approved protocols.
  • Audit electronic data trails to confirm adherence to applicable procedures.
  • Resolve data discrepancies with clients and ensure all corrections are implemented.
  • Adhere to SOPs and cGMP standards, providing management with regular updates on deviations or discrepancies.
  • Suggest improvements to the review process and perform other assigned duties as needed.

Qualifications:

  • B.S. in Chemistry, Biology, Biochemistry, or related scientific field.
  • Minimum 5 years of experience in GMP Quality Control within the pharmaceutical/biotech industry.
  • Experience with method transfer, analytical method implementation, and method lifecycle management.
  • Strong technical writing, data analysis, and problem-solving skills, including CAPA implementation.
  • Excellent organizational, communication, and teamwork abilities.
  • Proficiency in LabWare LIMS, Excel, Word, and PowerPoint preferred.

Job Tags

Remote job,

Similar Jobs

Talentoma

Remote Customer Support Specialist Job at Talentoma

 ...questions and support others No experience required paid training is provided Customer service experience (call center, retail,...  ...remote work from the comfort of home ~ Paid training starting day one ~ Flexible scheduling options (including weekends based on... 

PMC Works

Certified Medical Assistant Job at PMC Works

 ...Currently Seeking Certified Medical Assistants in Tennessee Temp to Hire and Direct Hire Your Role with the Company: Your role as a clinical medical assistant is providing direct patient care. As a clinical medical assistant, you'll handle tasks such as taking... 

Medix™

Office Scheduler-247652 Job at Medix™

 ...Job Title: Medical Office Administrative Assistant Location: Santa Monica, CA Schedule: Full-Time, MondayFriday, 8:30 AM4:30 PM Compensation: $21$24/hr DOE Interview Availability: Thursday & Friday morning (11/611/7) Overview We are seeking a... 

Musselman & Hall Contractors

Preconstruction Intern Job at Musselman & Hall Contractors

 ...We are looking for an energetic and eager individual to join our Internship Program for the summer! Throughout your internship, you will have the opportunity to immerse yourself in the diverse facets of Preconstruction. This experience promises not only exposure to the... 

Vacuum Process Engineering, Inc.

Machine Operator Job at Vacuum Process Engineering, Inc.

 ...that is seeking a long-term career with a stable company. Pay Range: $27-33/hour Summary/Objectives: The goal of the Machine Operator will be to increase workflow in the shop by being able to setup, operate, and troubleshoot jobs independently. The candidate...