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.