SQAFYI - Software QA Resource - FYI

US-Durham-NorthCarolina: Sr Quality Assurance Specialist

To see other opportunities, please visit http://sqa.fyicenter.com
Date: 20-Sep-2010

Sr. Quality Assurance Specialist

• Assist with developing, implementing and maintaining QA systems. • Conduct periodic reviews of SOP’s 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

• Bachelor’s 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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Thank you,
Team SQAFYI - Software QA Resource FYI

US-Durham-NorthCarolina: Sr Quality Assurance Specialist