GxP QUALITY SPECIALIST II
Proclinical is currently seeking a GxP Quality Specialist for a biotechnology company located in Foster City, CA. successful candidate must possess knowledge of the drug development process and expertise in providing quality oversight for process, and supporting internal audits and regulatory inspections.
- Conducting process reviews by assessing procedural documents like SOPs, WRKs, MANs, and other Business Enabling Documents.
- Conducting TMF reviews of essential documents.
- Identifying risks, gaps and/or areas for process improvement and areas for improvement in existing PDs.
- Supporting internal audit and/or external regulatory authority inspection activities.
- Supporting and tracking CAPA activities.
- Assisting in tracking of Training records.
- Assisting in Vendor Oversight activities.
- Defining, implementing and tracking quality metrics.
- Collaborating with other quality and compliance functions.
- Supporting implementation of changes in processes andqualir PDs.
Knowledge and Skills:
- Demonstrated expertise in working in GxP Quality functions.
- Knowledge of Business Analysis and experience in creating and modifying process maps.
- Demonstrated ability to create/update documents with high degree of accuracy.
- Demonstrated ability to work independently with accuracy.
- Expertise in MS Word and other MS Office tools.
- Strong verbal, written, and interpersonal communication skills.
- Demonstrates facilitation skills and uses collaborative approach to solve problems.
- Demonstrates ability to complete high quality work on multiple concurrent projects under tight deadlines.
- Required experience working in Life Sciences and/or GxP environment.
- Prefer experience working in Clinical Operations or Biometrics.
- Prefer experience in interpreting regulatory agency guidance documents.
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 Sherron Howard at (+1) 267-435-8600 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.
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