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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