Quality Control Analyst

1 month ago

Cambridge, United States Proclinical Staffing Full time

Quality Control Analyst - Contract - Cambridge, MA

Proclinical is seeking a Quality Control Analyst for a contract role in Cambridge, MA.

Primary Responsibilities:

The successful candidate will be responsible for ensuring the completeness, consistency, and accuracy of regulatory filings, laboratory data, and reports. This role offers flexibility for remote work, with some on-site presence expected. Occasional travel to CMO/CTL sites may also be required.

Skills & Requirements:

  • Degree in chemistry, biology, biochemistry, or a related scientific field.
  • Experience in a GMP Quality Control function within the pharmaceutical/biotech industry.
  • Knowledge of method transfer and analytical method implementation.
  • Strong technical writing skills, particularly for investigations.
  • Proficient in data analysis and interpretation with excellent attention to detail.
  • Solid problem-solving skills and experience in conducting investigations and implementing CAPA.
  • Strong organizational skills with the ability to manage multiple tasks autonomously.
  • Excellent communication and teamwork abilities.
  • Proficiency in LabWare LIMS, Excel, Word, and PowerPoint preferred.

The Quality Control Analyst's responsibilities will be:

  • Verify the integrity and traceability of regulatory dossier sections.
  • Review regulatory dossier sections against associated reference methods and reports for accuracy.
  • Review analytical data for accuracy and completeness.
  • Ensure data integrity in laboratory notebooks, worksheets, logbooks, and electronic data.
  • Review complex notebooks involving analytical method validation, verification, and transfer testing.
  • Ensure electronic data generation follows applicable procedures.
  • Discuss necessary corrections to analytical data or reports with clients.
  • Adhere to Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMP).
  • Consult with management regarding assignment priorities and communicate any deviations/discrepancies.
  • Provide feedback and suggest improvements to the review process.
  • Perform additional duties as assigned by management.

If you are having difficulty in applying or if you have any questions, please contact Anderson Maldonado at a.maldonado@proclinical.com

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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