Quality Assurance Specialist III - United States
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The QA Specialist III contributes to the completion of milestones associated with specific projects and supports ongoing Quality Assurance responsibilities in support of the manufacture, testing, and release of product. May determine methods and procedures on new assignments and may provide guidance to other lower-level personnel. Performs all responsibilities in accordance with company policies, procedures, and federal regulations.
The QA Specialist III position reports directly into the Manager of Quality Assurance Operations at the Alexion Rhode Island Manufacturing Facility (ARIMF) located in Smithfield, RI. This position will provide coverage from Wednesday through Saturday on a 10-hour shift. The position requires the ability to gown and enter classified areas.
The QA Specialist III is responsible for ensuring continuous support for Commercial and Clinical manufacturing operations including, but not limited to: serving as the QA contact for major and critical deviations; support manufacturing process improvement, completed risk assessments and mitigation strategies for ARIMF operations, as well as mentoring of junior staff. QA Operations support includes performing CGMP compliance review of manufacturing batch records, log books, corrective work orders, deviations, CAPAs, and other GMP documents as needed.
The QA Specialist III position functions in an independent manner and provides strategic oversight for the manufacturing areas, with limited direction for area management. The QA Specialist III will work on problems of diverse scope in which analysis of situation data and a strong compliance background is essential. The Specialist will exhibit a great degree of ingenuity, creativity, and resourcefulness to completed tasks in accordance with site objectives.
- Reviews manufacturing and support records to certify compliance with specifications and procedures.
- Makes recommendation to Quality Assurance Management for the release of product based on Quality Assurance record review and approval.
- Works closely with Manufacturing and Quality Control to resolve open issues resulting from record reviews, on the floor walk through activities of the facility, and deviation issues.
- Reviews and assesses deviations; includes performing risk assessments, participating in root cause analysis investigations, tracking, follow-up and reporting/trending.
- Reviews and approves Corrective and Preventative Actions (CAPA); includes tracking, follow-up, and reporting/trending and evaluating CAPA for effectiveness.
- Interacts professionally with company management, internal departments and other sites to effectively implement and maintain Quality Systems.
- Representing Quality Assurance at various project and technical meetings, as needed.
- Working with all departments to ensure timely completion of Deviations, CAPA, Change Controls, Investigations, and Environmental Excursions
- Capturing and reporting metrics around Quality System and Batch Record review turnaround times and closure/approval times.
- Providing on the floor support to Manufacturing
- Reviewing Manufacturing batch records and completing required documentation for batch disposition
- Document creation and review, including Standard Operating Procedures, protocols, and reports
- Performing Internal Audits and Data Audits, as needed.
- Providing training to site personnel and contractors on GMP and the Quality System procedures
- Reviews and approves corrective maintenance, out of tolerance, critical alarms, and other equipment and maintenance management records for the ARIMF facility.
- Provides direct in the plant review of log books, manufacturing batch records and other GMP documents
- Collaborates with manufacturing and support functions to drive timely closure of deviations, CAPAs, and other GMP documents.
- Completes data verification for GMP technical documents and protocols.
- Inputs GMP information into electronic databases and generating reports from these systems for reporting of metrics related to Quality Systems
- Minimum of 5-8 years GMP related experience in biopharmaceutical / pharmaceutical or related industry with 3 years direct Quality experience in Commercial and/or Clinical CGMP pharmaceutical manufacturing.
- Excellent written and verbal communication and negotiating skills.
- Ability to prioritize daily activities in order to meet internal and external customer needs in a fast-paced environment.
- Ability to monitor and report on assigned tasks, goals and objectives.
- Ability to work on Quality projects where analysis of data requires evaluation of identifiable factors.
- Planning and organizational skills are required as are good interpersonal skills and the ability to communicate well, both verbally and in writing.
- Preferred Qualification, but not required includes experience with Quality Control analytical test methods and associated investigations.
- Bachelor’s degree required; preference given to candidates with degrees in chemistry or biological sciences
This position will work Wed – Sat, 10 hour days.
Smithfield, RI, United States
Alexion is a global biopharmaceutical company focused on developing and delivering life-transforming therapies for patients with devastating and rare disorders. Alexion developed and commercializes Soliris® (eculizumab), the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), two life-threatening ultra-rare disorders. As the global leader in complement inhibition, Alexion is strengthening and broadening its portfolio of complement inhibitors, including evaluating potential indications for eculizumab in additional severe and ultra-rare disorders. Alexion’s metabolic franchise includes two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare disorders, Strensiq® (asfotase alfa) to treat patients with hypophosphatasia (HPP) and Kanuma™ (sebelipase alfa) to treat patients with lysosomal acid lipase deficiency (LAL-D). In addition, Alexion is advancing the most robust rare disease pipeline in the biotech industry, with highly innovative product candidates in multiple therapeutic areas.
As a leading employer in our industry, Alexion is proud to offer a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Alexion, please visit www.alexionpharma.com or download our App for iPhones and Blackberries.
Alexion is an Equal Opportunity /Affirmative action employer