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

Maintenance Mechanic - Night Shift Job at Knauf North America

 ...employees to do the same, as necessary. This includes understanding and complying with the lock-out/tag-out procedures. Determines if machines need to be taken out of production for repairs or service. Takes an active role in the requisitioning of parts/materials... 

Taurus Industrial Group, LLC

Electrical Foreman Job at Taurus Industrial Group, LLC

Summary Responsible for assisting the Assistant Superintendent or Project Manager on large project or several small projects. Small job responsibilities would be for total project with support from the home office project manager. On a larger project with several foreman...

Farm Job Search

Dairy Farm Herdsman Job at Farm Job Search

 ...Dairy Farm Herdsman (6203) Location: New York State JobNumber: 6203 Dairy Farm Herds Person position available immediately on modern 1,000 cow plus dairy farm in Central New York State. MUST have experience with fresh and sick cows, helping with vet checks, vaccinations... 

Tandym Group

Licensed Clinician (LMSW, LCSW, LMHC, or LMFT) Job at Tandym Group

A nonprofit organization on Long Island (Suffolk County) is currently seeking a licensed professional (LMSW, LCSW, LMHC, or LMFT) to join their team as their new Licensed Clinician. In this role, the Licensed Clinician will be responsible for working with adults navigating...

SGS Consulting

Production Assistant Job at SGS Consulting

 ...Job Responsibilities: Assist in several manufacturing areas to include the Press, Plate and Mail rooms of the nightly printing plant...  ...and relaying information to management Operation of production information management system software (PDIMS) to record nightly...