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
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