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

Knauf North America

Production Associate Job at Knauf North America

Knauf Insulation North America is the world's fastest-growing insulation manufacturer. We are wholly committed to the conservation of the environment while also sustainably developing and manufacturing a comprehensive line of acoustical fiberglass insulation for residential...

Belcan

Electrical Technician Job at Belcan

 ...Job Title: Electrical Technician I Location: Livonia, MI Zip Code: 48150 Duration:6 Months Education and Experience (required): * High school diploma or equivalent. * No previous experience required Essential Duties and Responsibilities: * Assemble,... 

120 DEGREEZ MEP Engineering

Mechanical Engineer (Multiple Levels) Job at 120 DEGREEZ MEP Engineering

 ...Job Description: Mechanical Engineer (Mechanical Drafter | Mechanical Engineer | Senior Mechanical Engineer) Location: Downtown San Diego, CA 92101 We are seeking skilled and motivated Mechanical professionals across multiple experience levels to join our team in... 

Pride Health

Phlebotomist Job at Pride Health

 ...Duration: 26 Weeks Shift: 5x8 (9:00 AM-5:00 PM) HS diploma/GED (required). Prior veni-puncture experience (preferred). Phlebotomy Certification, computer skills, blood collection experience 2 years+, and great customer services skills Benefits: Pride... 

Stellar

Senior Mechanical Engineer Job at Stellar

 ...the candidate can design such systems with limited direction, can mentor others, and be capable of supervising the work of other engineers and designers while serving as the lead engineer on any given project. The candidate must have a working knowledge of the International...