Clinical Nurse Auditor - remote
06/08/2022,
University of Massachusetts Medical School
Boston, MA
Auditor
Senior QA Auditor (CMC Laboratory)
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Senior QA Auditor (CMC Laboratory)
Job Description:
The Opportunity Do you want to find solutions to complex challenges in a modern Research environment? Seqirus has an exciting opportunity to join the growing team at our Research center in the Waltham/Cambridge MA area. With expertise in influenza science, our team works on the latest research, pioneering technologies in influenza vaccines. We continue to explore novel concepts for longer term transformational approaches to influenza protection. We operate as one integrated global research and development organization, drawing together expert staff from different countries to collaborate with us. Together, we're working to protect communities from seasonal influenza and global pandemic threats. Reporting to the Head, R&D QA GxP, you will provide QA oversight of lab-based / small-scale activities performed at the site level by R&D under non-regulated or GLP or GCLP conditions. Develop quality systems related to area of oversight. The Role You will provide Quality oversight of R&D activities at the site levelConfirm that activities in Technical Development (TD), Clinical Research and in Research are compliant with GLP or GCLP and data integrity is maintained on an ongoing basis.Develop Quality Systems and author QA standard operating procedures (SOPs) and supplemental documents and support implementation.Provide QA oversight and help R&D use existing systems to manage documentation, changes, deviation investigation, CAPA, internal audit processes, commitments to Health AuthoritiesAudit documentation for compliance, completeness and data integrity and escalate risks to senior managementPerform study-based inspections (important phase and data audits) for GLP or GCLP areas and support regulatory inspectionsConduct due diligence assessments for proposed external vendor relationshipsOversee and track metrics for the site You will establish relationships with Technical Development to support daily activitiesAdvise R&D on applicable requirements, deferring to more senior members in CRQA for complex issuesAcquire and maintain knowledge of Seqirus SOPs and Policies, regulatory requirements and guidance (e.g., Good Laboratory Practice, Good Clinical Laboratory Practices, Good Clinical Practices), to ensure that advice and appropriate QA technical support on all quality/compliance-related matters are provided to R&D at the site level for relevant markets Your skills and experience Bachelor's degree in a scientific discipline / Life Sciences required (e.g., Biology, Microbiology, Chemistry or Pharmacy). Graduate degree acceptable.3+ years in Quality Assurance in a GxP regulated environment within the pharmaceutical industry.Previous work in a laboratory (in vitro or animal studies) in a QC, Research, Development, or Quality role required.Experience working across different market areas and different phases of R&D preferred (Product Development/ GLP Toxicology, Clinical Phase 1, 2 and 3) Benefits: Medical, Dental, Vision, Life Insurance, 401K, and PTO available from your first day of hire. Our Benefits Seqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives. Learn more about some of the benefits you can participate in when you join Seqirus. About Seqirus Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about Seqirus. We want Seqirus to reflect the world around us As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at Seqirus. Do work that matters at Seqirus! Watch our ‘On the Front Line’ video to learn more about Seqirus