Quality Assurance Specialist IV

JOB DESCRIPTION 

The Quality Assurance Specialist IV will be responsible for all activities involving quality assurance and compliance with applicable cGMP requirements.  Performs manufacturing batch record, test record and data forms review for the disposition of Phase III clinical product.  Independently prepares for and conducts internal and external audits, and reviews/analyzes data and documentation.

 

JOB RESPONSIBILITIES

 Assist in the implementation and execution of QA systems to support lot release, audit and trainingCritically evaluates investigations including OOSs, CAPAs (Corrective and Preventive Action) and complex deviations. Review method validation and process validation reports for complianceWrite, review and approve SOPs, batch records, material specs. and test recordsTrend and report QA related information (Deviations, CAPA, etc.)Performs manufacturing batch record, test record and data forms review for the disposition of Phase III clinical product.Review and approves Validation protocols (Manufacturing, Test Method Validation, Equipment (IQ, OQ, and Process Validation, Cleaning Validation, etc.)Independently prepares for and conduct audits (Internal, Vendors, Suppliers, Sub-Contractors Testing Facilities, Clinical).  Prepares final reports and assists in and monitors the implementation of corrective actions for close out.May initiate and/ or assist departments with investigations related to manufactured products.  Prepares routine updates and project status report of Quality Assurance activitiesIs expected to be able to critically evaluate their peer?s work for compliance to cGMP and specifications.Assist with preparation for FDA and other regulatory inspectionsPerform other duties as required.

 

 

 

QUALIFICATIONS

 BS/MS degree in a scientific discipline is required with at least 8 years of related QA experience in a cGMP pharmaceutical environment

ABOUT BIOVAX AND BIOVEST

Biovax, inc. is the manufacturing and production arm and a wholly owned subsidiary of Biovest International, a publicly traded company (BVTI.OB) and a pioneer in the development of individualized immunotherapies for life-threatening cancers of the blood system. Biovest's therapy for follicular non-Hodgkin's lymphoma, BiovaxID, is currently in a Phase 3 pivotal clinical trial at over 20 major centers in the U.S. being conducted under a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute. Biovax manufactures the BiovaxID vaccine in its GMP manufacturing facility in Worcester, MA. Biovest has also been a leader in the manufacture and development of automated cell culture instrumentation for over 20 years. It?s Advanced Instrumentation Division in Minneapolis is poised to introduce the innovative AutovaxID-C cell culture instrument that is expected to revolutionize the manufacture of personalized cell based therapeutics. Biovest and Biovax are seeking highly motivated individuals interested in joining a growing organization developing cutting-edge therapeutics. Biovax provides a competitive salary and a full range of benefits.

For further information, please visit Biovest's website: www.biovest.com.