Quality Assurance Specialist III - United States
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- The QA Specialist III will contribute to the completion of milestones associated with specific projects and supports quality systems related to document creation, reviews, training, change control, deviations, corrective actions/preventative actions, and investigations. Expedient retrieval of organized and complete records for internal requests, agency requests, and regulatory inspections is a key element to this position. Equally important is the ability to review documents for compliance to regulations, guidances, and internal procedures/policies. This position will provide the incumbent the unique opportunity to lead in various areas of GxP Quality Systems.
- The QA Specialist III will assist in daily activities for the ongoing development and operations of the GxP Archive with Quality. In support of Document Control, the candidate will take the lead in carrying out the operational requirements that result from policies, procedures, regulations, and guidances governing the management of records that exist in print and electronic form. This role will help manage record retention schedules, outreach to other internal/external archival support staff, and the acquisition of GxP Archive records.
- Performs all responsibilities in accordance with company policies, procedures, global regulations and safety requirements.
- Creates, edits, and/ or manages functional area documentation in compliance with established processes.
- Reviews records to certify compliance with procedures.
- Interacts professionally with company management, internal departments and other sites to effectively implement and maintain Quality Systems.
- Technical expert and liaison for FirstDoc database supporting New Haven functional areas.
- Works with colleagues to support timely completion of Deviations, CAPA, Change Controls, including SME assessments, Investigations, and Document Reviews
- Minimum 3-5 years’ relevant experience with solid knowledge of GxP requirements.
- Minimum 1-2 years’ relevant experience in document management, SOP authoring and review.
- Experience in developing, implementing, and evaluating archives or records management processes and systems. This includes cataloging, filing, and retrieving of records.
- Experience with GxP global regulatory requirements.
- Experience with electronic systems (e.g.FirstDocs and TrackWise) and databases.
- Knowledge of the creation and management of records retention schedules
- Knowledge of archival metadata and metadata management
- Ability to work in a fast-paced environment
- Demonstrated ability to achieve results in a highly matrixed environment.
- Comfortable communicating and working within all levels of the enterprise.
- Highly motivated, energetic learner possessing the highest professional and personal standards, unquestioned integrity and business ethics.
- Bachelor’s degree required.
New Haven, CT, 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.