Proclinical is currently recruiting for an experienced Quality Assurance Director with a pharmaceutical company located in Hicksville, NY. Successful candidate will oversee and ensure, quality policy and regulatory obligations, are implemented and followed company-wide.
- Perform and coordinate the QA department and duties within.
- Review SOPs, STPs and revise accordingly.
- Maintain all Quality Assurance and Quality Control master files.
- Review and update Quality manual accordingly.
- Prepare and carry out validation activities as required.
- Perform internal and vendor audits.
- Document and review quality requirements and agreements of raw materials with suppliers.
- Investigate and provide suggestions for quality and health and safety.
- Ensure that manufacturing processes comply with standards at both national and international level.
- Work with operating staff to establish procedures, standards, systems.
- Document and determine training needs.
- Record, analyze, distribute and archive statistical information.
Skills and Requirements:
- BS degree required.
- Experienced in ISO 13485:2016 Quality Management System (5 years).
- Experienced in SOPs, Reports and Document Control (5-10 years).
- Experienced in Complaint Handling, CAPA, NCMR (5-10 years).
- Coordinating outside contract laboratories as well as ISO certifications and reassessments.
- Must be familiar with: cGMPs, Part 11 compliance, ISO 13485:2016, CAPAs, Agency Audits, Internal / external cGMPs, GLP, CFR, Metrology SOP/STP.
- Health Canada, MDSAP program knowledge a plus.
- Regulatory experience is a plus.
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 Ysabel Capitan at (+1) 347-293-1123 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.