Proclinical is currently recruiting for a QA Specialist for a biotechnology firm located in New York, NY. Successful candidate will assist in the review and approval of component and product specs, batch records, and COA's, with a focus on AAV Gene Therapy programs.
Skills and Responsibilities:
- Review and manage Gene Therapy production batch records and associated data for product release. Determine if records are within range of cGMP regulations. Review data obtained for compliance specifications and report abnormalities.
- Ensure completeness and accuracy of the information contained in all documents, document files, databases, and documentation systems.
- Assist in the review, approval and follow-up of exception documentation. Exposure to events that occur in the Gene Therapy operational environment is a plus.
- Assist in the Supplier Management program. Plan, execute and oversee material transfers.
- Assist in the review and approval of Change Controls.
- Work proactively with functional area SOP-owners to assure upkeep of their governing SOPs.
- Ensure orderly storage and expedient retrieval of Quality System documents. Update documentation database as needed.
- Classify documents and accurately archive them for seamless retrieval.
Skills and Requirements:
- BS in a relevant discipline with significant QA experience in the pharmaceutical or biotech industry.
- Experience performing Gene Therapy batch record review activities and performing systems related internal and external audits is essential.
- Proficient in FDA, EU, and ICH regulatory requirements and guidelines related to cGMP operations.
- Effective communication (verbal and written) and strong interpersonal and teamwork skills.
- High attention-to-detail.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Matt Tong at (+1) 646-878-6308 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
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.