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

MGC Diagnostics

VP of Finance & Accounting Job at MGC Diagnostics

 ...role has the ability to promote to CFO. Summary of a VP of Finance & Accounting's Role: Financial Leadership: The VP of...  ...plans, projections and budgets. Represent company to banks, public / private auditors and officials. Remain current on audit best... 

Digital Health New York

RN - Psychiatric Job at Digital Health New York

We are seeking a dedicated RN - Psychiatric to join our team in New Britain, CT, offering $2,322/week. Responsibilities Assess and monitor patients' mental health status and develop individualized care plans. Administer medications and provide therapeutic interventions... 

Breakwater Oral Surgery

Surgical Assistant Job at Breakwater Oral Surgery

 ...Surgery & Dental Implants breakwatersurgery.com Dental Assistant Oral Surgery Surgical Assistant Oral Surgery Location...  ...preferred. Licensed dental assistant status is preferred. Radiology certification is a plus. We are an Equal Opportunity... 

24 Seven Talent

Handbag Accessories Designer Job at 24 Seven Talent

Handbag Accessories Designer About the Role We are looking for a talented and meticulous Designer to join our creative team, focusing on handbags and backpacks for Juniors and Kids categories. The perfect candidate will bring strong expertise in textile print design...

Zeitview

Flight and Field Capture Specialist (Drone Pilot) Job at Zeitview

 ...Zeitview is active in over 70 countries. The Flight and Data Capture Specialist is responsible for conducting flight operations utilizing drones, various payloads, and Zeitviews proprietary software to collect imagery for critical infrastructure. The primary function...