Lead QA Specialist (07-1-2040-10B)

Lead QA Specialist (07-1-2040-10B) Department/Division: Quality Assurance/Safety Job Type: Full Time, Employee Company: Vertex Pharmaceuticals Inc. Location: US-MA-Boston Job Reference Id: 544   Description: This position is responsible for the Validation oversight at Vertex Contract manufacturing Organizations, development and administration of Quality Agreements and Investigation Management. In addition, this position is responsible for review of master and executed Drug Substance, Intermediate Drug Product, Bulk Drug Product, Packaged & Labeled Drug Product and management of all applicable investigations associated with product, materials and Technical Complaints. The selected candidate will ensure that technical and compliance issues are consistently in a manner consistent with cGMP requirements, and will drive the review process to timely completion in order to support product disposition. Qualified candidates will minimally have a Bachelor's degree in Chemistry or a related scientific discipline and at least 8 years of experience in the biopharmaceutical/pharmaceutical industry, including direct experience in a GMP environment. Strong and proven knowledge of cGMP, ICH and other requlatory requirements as they apply to API and Drug Product manufacturing and validation are required. Additional expectations for this position are: Ability to work independently, highly motivated with initiative to fill gaps identified in regulated systems, good investigative skills and the ability to assure that non-conformances are adequately investigated to uncover root cause conditions, ability to work as a strong team player (internal to the Vertex organization and with Vertex contract manufacturing organizations). The candidate must also have Validation expertise covering API, Intermediates, Final Dosage forms, Packaging, Shipping, Cleaning, Support Systems, Computers, and Equipment Qualifications. In addition this individual must have proven knowledge in managing Quality Agreements. Experience with electronic data systems (LIMS) or electronic documentation systems (Documentum, QUMAS, TrackWise) would be a plus. Minimum Education Requirements: Bachelor's Degree, Chemistry or related science M.S. (or equivalent degree) and 3 – 5 years of relevant work experience, or B.S. (or equivalent degree) and 8+ years of relevant work experience in a Biotech, Pharmaceutical, or Bio-Pharmaceutical Manufacturing site in a Quality Assurance or combination of QA/Operations role Apply Now