Arbor Vita Corporation (AVC) was founded in 1998 and its strategy is to develop and market innovative protein-based diagnostics by making user friendly and more accurate diagnostic test kits. AVC focuses on the development of novel diagnostics and therapeutics using their proprietary PDZ proteomics platform to improve healthcare worldwide. AVC was the first to obtain FDA clearance for a rapid test for H5N1 Avian Flu in 2009 and recently developed a new rapid H7N9 Influenza detection test kit. AVC has launched its CE IVD marked cervical cancer biomarker test that is the first in AVC’s suite of tests based on its OncoE6TM test platform. AVC also maintains an active program to develop a therapeutic solution for HPV-induced cancers.
Arbor Vita Corporation is seeking a candidate with the ability, expertise, and passion to promote quality achievement and to improve performance across the organization. AVC’s Quality Assurance (QA) is responsible for leading the development, implementation, and maintenance of quality assurance processes and systems while ensuring highest quality practices are observed within AVC and its contract partners. As a standard, the QA is responsible for approving the release of all production lots that support commercial operations.
Further responsibilities include:
• Ensure adherence to AVC internal quality standards for product and process quality including appropriate GMP and regulatory requirements (FDA 21 CRF 820).
• Work with AVC colleagues to improve internal Standard Operating Procedures (SOPs) that document processes necessary to assure product and process quality
• Lead coordination with any regulatory audits of AVC business practices to ensure cGMP and regulatory compliance.
• Create and maintain a change management process to ensure appropriate business, legal, regulatory, technical and quality alignment on product and process changes.
• Review all product package, label and insert changes to ensure quality compliance
• Coordination of pre-approval and annual quality inspections of all production, distribution, warehousing and laboratory vendors supporting quality product supply. Make recommendations for and implement corrective actions as necessary to ensure product conformity with AVC and Government standards.
• Responsible for appropriate training of AVC personnel in critical aspects of Quality Assurance and for documentation of training
• Manage QA staff, with oversight for quality assurance responsibilities:
o Writing, implementing, and/or approving changes to controlled documents (e.g. SOPs, specifications, protocols, reports, manufacturing procedures, change controls, etc.) and rework procedures as needed.
o Ensuring timely review and approval of manufacturing batch records, quality control records for in-process and finished goods release, NC reports, CAPA plans, etc., to facilitate product release and demonstrate compliance to governing regulations and AVC’s internal procedures.
o Performing Incoming Inspection of Raw Materials and Material Disposition and a wide variety of activities to ensure compliance with quality systems, quality procedures, and applicable regulatory requirements.
• Manage document control staff, with oversight for document control responsibilities:
o Issuing numbers for DCO, NC, CAPA, SCAR, CC, parts, and such documents, maintaining logs or master lists, and publishing approved documents onto company network
o Maintaining approved documents, training records, and logs in Document Control
o Informing affected parties upon release of new documents
The ideal candidate has a required minimum of a Bachelor's Degree, preferably in a scientific or technical field, as well as 6-8 years direct experience within the commercial medical device or pharmaceutical industry. Candidates should have extensive knowledge of quality systems and regulatory requirements. Experience in starting, directing, and maintaining a broad corporate quality system is highly desired. Experience with supplier evaluations and ongoing interactions with supplier partners are desired. Experience working in a contracted supply environment with significant outsourced production and/or distribution is needed. Possessing strong written and verbal communication skills is highly desired. The ability to work independently to resolve complex issues and negotiate best solutions is highly desired.