Sr. Quality Assurance Associate

Purpose & Scope:Review and approve batch records, deviation investigations, and reports. Provide inter- andintradepartmental support in the preparation and review of documentation related to and including manufacturing processes, equipment, and computer systems that affect GMP-related activities.Administers the QA deviation and CAPA system, internal audit system, supplier audit system, andall other necessary quality systems. Provides GMP guidance to other departments and projectteams.Essential Job Responsibilities:Assist in the investigation, reporting, and resolution of major deviationsReview and approval of validation protocols and reportsReview and approval of all GMP document revisions including SOP's, MPR's, specifications, test methods, etc.Administration of the deviation and CAPA systemAdministration of the internal audit and supplier audit programPerformance of internal and external auditsHost and support for audits of APT by third parties, Avara corporate, and all regulatory bodiesReview and approval of CAPA plans and completionFollow up on CAPA and deviation to ensure effectivenessRepresentation of QA on site-wide and regional and global project teamsProvide GMP guidance to all affected departments at APTDevelopment and preparation of all QA metrics and reporting the results to APT and regional and global management (Q10)Development and administration of APT OJT and GMP training programUse of statistical analysis tools to evaluate dataDevelopment and use of risk assessment toolsQuantitative Dimensions:This position has direct impact on batch processing and release, disposition of materials andcomponents, approval and disposition of minor and major level deviations, the compliance state ofAPT, and site wide project support. This position has direct interaction with international regulatoryagencies, APT suppliers and vendors, and other Avara affiliates and departments. This position hasan indirect impact on Avara-wide compliance and other company-wide projects.Organizational Context:Reports to the Manager of Quality AssuranceNo direct reportsQualifications:Required3-5 years previous experience with GMP within the pharmaceutical industry3-5 years direct QA experienceGood verbal and written communication skills with basic computer skills.Attention to detail and accurate record keeping.Able to multi-task.Basic understanding and knowledge of GMPs and the pharmaceutical industry, quality practices and standardsExperience with statistical data analysis preferredMust be able to read, write and understand the English language (statement common to all Job Descriptions)Must be able to work independently with some supervision.Must be able to gather and evaluate data to make sound decisions.Must be able to exercise judgment in the resolution of problems.Office environment; must be able to sit at a desk for extended periods of time.Occasionally requires ability to climb stairs and the ability to perform while wearing required personal protective equipment, such as respiratory protection, eye protection, hearing protection and safety shoes.Knowledge of CFR parts 210 &211Experience with Microsoft programs (Excel, Word, etc.)PreferredBachelor’s degree