Quality Auditor
📋 Role Overview & Responsibilities
Our client - a trailblazing global pharmaceutical powerhouse - is seeking a Quality Auditor to join their growing team.
Type: Contract (one year)Pay: $31.82/hrLocation: Remote
Responsibilities:Maintain an expert level of knowledge related to GMP requirements and industry trends.Advise supported areas on requirements for all assigned project responsibilities.Independently audit applicable regulatory filings. Ensure compliance with regulatory requirements. Work with areas to resolve any audit findings.Identify training needs and oversee, develop and/or conduct training or orientation sessions for internal staff and client groups as well as staying current with own training requirements.Identify need for and/or develop SOPsSupport preparations for regulatory agency inspections. Lead audits.Keep close track of submission timelines and meets deadlines while still maintaining all audit goals.Identify and manage issues on a continuous basis.Provide guidance to the project teams.Update the auditing team with changes in Submission Timelines, or other changes (Specifications, Methods, etc.)Provide tracking, trending and metrics for GMPQ auditing activities.
Qualifications:B.S., M.S. and/or PhD. degree in an appropriate Science, Engineering discipline.Minimum of 5-10 years’ experience with B.S./M.S., or five (5) years with PhD. (Experience should be in pharmaceutical/biotechnology, quality or compliance role). Extensive working knowledge of cGMPs and technical aspects of support area are required.Experience supporting Internal and/or external audits preferred.
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