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Quality Assurance Specialist

Job Post Index 200166-Sy##
Location Andover, MA
Description: Description
  • Prepares and reviews required documentation such as GMP, GLP, GCP procedure manuals, quality control manuals, engineering documents, manufacturing instructions, and change authorizations
  • Coordinates the review and revision of procedures; specifications; and forms.
  • Oversees ongoing projects and reviews status of projects.
  • Assesses project issues and develops resolutions to meet productivity; quality; and client-satisfaction goals and objectives.
  • Develops mechanisms for monitoring project progress and for intervention and problem solving.
  • Work is achieved by individual or through project teams; utilizing technical or subject matter expertise to achieve results.
  • Accountable for investigation of quality issues and reviews the results of Manufacturing or Quality Laboratory investigations.
  • Responsible for deviation investigations and out-of-specification and atypical result investigations.
  • Investigates events to gather relevant information necessary to develop investigation.
  • Ensures that reports are aligned with regulatory requirements; site standard procedures; and company policies.
  • Reviews protocols; analytical results and/or documents associated with investigations.
  • Ensures the compliance with regulations for the quality of the investigations; the identification of the root cause; the identification of the appropriate correctives and preventative actions; and the product impact and disposition.
  • Utilize six-sigma methodology.
  • Accountable for activities involved in the evaluation process related documents to determine if product specifications are met; ensuring that established sampling and statistical process control procedures are followed
  • Identifying and reviewing deviations from established standards in the manufacturing and/or packaging of products; and reviewing and approving investigations and change control activities to ensure compliance with configuration management policies
Skills: Qualifications
  • Skilled in Technical Writing; Quality Systems Documentation/Records Control; Product Manufacturing; Product Release; Incident Investigation; Corrective and Preventive Action (CAPA); and GMP.
  • Requires relevant scientific education; skills; and knowledge
  • Skilled at the use of Enterprise systems including Quality Tracking System (QTS); Laboratory Information Management System (LIMS); SAP and company document repositories
  • Quality, Global Quality Tracking System (GQTS), Quality Assurance/Quality Control

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