US-Durham-NorthCarolina: Sr Quality Assurance Specialist
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Sr. Quality Assurance Specialist
Assist with developing, implementing and maintaining QA systems. Conduct periodic reviews of SOPs and quality systems and implement corrective actions Participate in regulatory agency inspections and third-party site audits Lead/ coordinate the auditing function and take appropriate action to assure compliance in PV activities, perform quality assurance, perform client and internal audits. Track and trend different elements of the quality system and prepare trending reports that will be submitted to Management. Provide QA guidance for the review and disposition of deviation, investigations and CAPAs Provide QA guidance for the Change Control process for equipment, utilities, computer systems, document control and processes Prepare vendor assessments, evaluations, and updating the Vendor database in support of the Vendor Program Write, review and approve Standard Operating Procedures (SOPs), specifications, protocols, final reports, and other related documents as QA representative Develop, schedule and conduct GCP compliance training Provide QA review of documentation submitted to regulatory standards agencies Comply with all relevant regulatory procedures Ensure that QA programs are current with industry standards and regulations May direct the work of other associates Perform other duties as needed
Bachelors degree required (life science, nursing, or pharmacy discipline preferred) Minimum 8+ years QA experience in a regulated environment at a biotech, pharmaceutical, veterinary health or consumer health products company with the ability to effectively advocate strategic quality systems approaches and promote compliance within the organization. Computer software validation experience a plus. Must have strong understanding of GMP and/or GCP regulations and applicable guidance documents Must be detail oriented and have exceptional organizational and interpersonal skills. Must have the ability to work in an environment of rapidly changing priorities and workload; manage multiple activities and assignments; to work both as a member of a team and in an independent, self-directed manner; to manage and organize work to meet timelines and to meet the attention of detail required to successfully complete assignments; to communicate effectively in English, both verbally and in writing; to implement training programs and to critically review documents; to effectively present information in front of groups of people; to maintain client and corporate confidentiality. This position requires occasional travel.
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Team SQAFYI - Software QA Resource FYI