Auditor - San Francisco, CA, United States - AA2IT
Description
Job Description
Job Description
Title: Quality Auditor
Remote Role
Education Minimum Requirement: B.S., M.S. and/or PhD. degree in an appropriate Science, Engineering discipline.
Required Experience and Skills : 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.
Previous experience required to perform job responsibilities may include: computer science, IT, quality assurance, auditing, or regulatory submission requirements.
Must have Experience and Skills: Experience supporting Internal and/or external audits. Role is 100% remote.
Responsibilities:
• Maintain an expert level of knowledge related to GMP requirements and industry trends as described in applicable worldwide regulations.
• Advise supported areas on requirements for all assigned project responsibilities as related to quality and communicate project status to management.
• 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 SOPs to ensure practices are accurately reflected.
• Represent GMPQ on inter-departmental and cross-functional teams, ensuring the flow of information and providing quality guidance.
• Support preparations for regulatory agency inspections. Lead Auditor Requirements include:
• Foster Collaboration, Drive Results, Make Rapid Disciplined Decisions. Demonstrate excellent organization skills. Can effectively manage multiple projects, and delegate audits to support team/auditors. Request additional resources as necessary. Maintains positive working relationships within CMC auditing team and client areas. Share and apply lessons learned. Holds self and other accountable. Clear communication skills (express in a clear, concise manner).
• Act as a single point of contact
• Keep close track of submission timelines and meets deadlines while still maintaining all audit goals.
• Identify and manage issues on a continuous basis (e.g. Unacceptable source documents, late submission of audit documents, delay in comments resolution that impacts submission time lines.)
• Provide guidance to the project teams in specific situations in terms of sources, audit maps, and workflows.
• Prioritize audit sections based on CMC request.
• Effectively listen to the auditee and seek to understand differing perspectives to resolve audit issues. Specific and/or additional duties may include, but are not restricted to:
• Provide tracking, trending and metrics for GMPQ auditing activities, Provide technical guidance to senior management in evaluating systems/tools. Assist GMPQ staff and client areas with the technical aspects related to the use of electronic audit tools.
• Support Process Improvement initiatives for CMC client and auditing area
AA2IT is in this business to make you successful. Strategy, Execution and Value. There are too many businesses that have solid, well-thought-out strategies that sit in a drawer somewhere collecting dust. Executing on Strategy effectively and measuring what matters drives the value. We start with your business strategy, align technology strategy, and create a roadmap that gets your business value.
AA2IT is a global firm providing Staffing and IT Solutions. We are headquartered in Texas, delivering successful talent acquisition and technology services. We are fully digital organization with a people centric and a technology driven vision.Company Description
AA2IT is in this business to make you successful. Strategy, Execution and Value. There are too many businesses that have solid, well-thought-out strategies that sit in a drawer somewhere collecting dust. Executing on Strategy effectively and measuring what matters drives the value. We start with your business strategy, align technology strategy, and create a roadmap that gets your business value.\r\rAA2IT is a global firm providing Staffing and IT Solutions. We are headquartered in Texas, delivering successful talent acquisition and technology services. We are fully digital organization with a people centric and a technology driven vision.
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