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Senior Specialist, R&D FLQA
3 months ago
Do you want to work with a company that tackles fascinating problems and find solutions to complex challenges? Seqirus has an exciting opportunity to join our expanding team in Holly Springs, NC. With an advanced manufacturing facility and expertise in influenza science we are one of the world leaders in the production of the influenza vaccine. We operate as one integrated global company, drawing together expert staff from different countries to collaborate. Together, we're working on the front line to protect communities from seasonal influenza and global pandemic threats. When you join Seqirus, you join a team dedicated to making a difference in people's lives. It's a feeling of possibility, creativity, and purpose that inspires us every day.
This position in R&D QA reports to the Associate Director, Quality and will provide Front Line QA oversight of bulk and fill finish manufacturing activities for clinical trial material produced in Small Scale Filling onsite in our Holly Springs, NC facility and related changes and deviations. Benefits Include flexible hours M-F, Onsite Café, Medical, Dental, Vision, Life Insurance, 401K, and PTO available from first day of hire.
Responsibilities
Perform real time batch record/logbook/document review concurrent with manufacturing on the floor and review executed batch records and development/validation/qualification protocolsPerform routine quality walkthroughs of site GMP facilities and operationsBe a quality representative on the floor during troubleshooting and issue resolution. Escalate potential product or process related issues as needed.Provide quality oversight of SSF critical alarm reports and corrective maintenance program, and area's quality systems and complianceUse of computerized systems such as: SAP, TrackWise, GLIMS, and BASSupport greater R&D FLQA organization including quality approval of deviations and/or change controls, quality support of suite teams, and quality representation on site projects.Responsible for knowledge of current local and international regulatory requirements ● Provide advice and appropriate technical support on all quality/compliance matters Additional Accountabilities:Ensure bulk and semifinished material for clinical batches comply with applicable Investigational New Drug (IND)/ Investigational Medicinal Product Dossier (IMPD) requirements, current clinical trial protocol registered with the applicable health authority and phase-appropriate cGMP.Support the development of batch production records, SOPs for manufacturing and testing, specifications, justifications of specifications, development/validation/qualification protocols and reports etc. to comply with site and global SOPs/Policies and applicable regulatory requirements for the phase of development.Ensure data integrity and by checking information back to source in reports, product specification file (PSF), regulatory filings etc. to ensure compliance and completeness.Author phase appropriate FLQA procedures for oversight of clinical manufacturing activitiesProvide QA oversight on the shop floor to the manufacture and distribution of products for clinical trials in Holly Springs, including sterile manufacturing and liasing with TD, Operations, QC, sterility assurance etc. as required.Implement the quality strategy for phase-appropriate manufacturing of clinical trial material, which may be either internal or outsourced to Contract Manufacturing Organizations, and identified areas for continuous improvement Establishes relationships with R&D QA and other global Quality functions:Advise R&D on applicable requirements, partnering with more senior members in R&D QA for complex issuesAcquires and maintains knowledge of Seqirus SOPs and Policies, regulatory requirements and guidance (e.g., Good Laboratory Practice, Good Manufacturing Practice, Quality by Design), to ensure that expert advice and appropriate QA technical support on all quality/compliance-related matters are provided to R&D at the site level for relevant marketsIdentify and escalate risks to compliance to senior managementProvide QA support and assists R&D in use of existing systems to manage documentation, changes, deviation investigation, CAPA, internal audit processes, commitments to Health AuthoritiesSupport internal audits and helps prepare for regulatory inspections, inspection finding responses related to applicable area of oversight and the provision of accurate reports on metrics, findings, risks and trendsMinimum Requirements:
Bachelor's degree in a scientific discipline / Life Sciences (e.g., Biology, Microbiology, Chemistry or Pharmacy).3+ years in Quality Assurance and/or in a GxP regulated environment within the pharmaceutical industry.Previous work in a Front Line QA organization, QC, Research, Development, Manufacturing or Quality role required.#LI-Onsite
Our Benefits
CSL Seqirus employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL Seqirus offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL Seqirus has many benefits to help achieve your goals.
Please take the time to review our benefits site to see what’s available to you as a CSL Seqirus employee.About CSL Seqirus CSL Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about CSL Seqirus.
We want CSL 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 CSL Seqirus.
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