Sr Specialist, R&D Frontline QA

Company: CSL Behring
Location: Holly Springs
Posted on: May 14, 2022

Job Description:

Job DescriptionJob Summary:This position in R&D QA provides Front Line QA oversight of bulk and fill finish manufacturing activities for clinical trial material produced in Small Scale Filling Holly Springs, NC and related changes and deviations. Provides support in Holly Springs for assuring quality during GMP clinical manufacturing activities, liaising with site colleagues to align on the preferred approach for proposal to stakeholders. Supports the development and maintenance of quality procedures and systems related to area of expertise.Major Accountabilities:Provide Quality oversight of R&D activitiesMajor Accountabilities:

• Perform real time batch record/logbook/document review concurrent with manufacturing on the floor
• Reviews and approves executed batch records and development/validation/qualification protocols
• Perform routine quality walkthroughs of site GMP facilities and operations
• Act as the 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
• Support the development, revision and implementation of SOPs, protocols, and other GMP documents
• Provide oversight of the SSF area's quality systems and compliance
• Use of computerized systems: SAP, TrackWise, GLIMS, Delta V, and BAS
• Utilize knowledge of root cause analysis and risk based decision-making
• Collaborate with cross-functional teams while triaging issues and when pursing improvements
• As needed, supports 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 mattersAdditional Accountabilities:
  • Ensures 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.
  • Supports 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.
  • Ensures data integrity and by checking information back to source in reports, product specification file (PSF), regulatory filings etc. to ensure compliance and completeness.
  • Authors phase appropriate FLQA procedures for oversight of clinical manufacturing activities
  • Provides 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.
  • Provides QA oversight to level 0 changes and minor/msjot deviations related to clinical trial manufacturing, and owns actions and otherwise supports higher level changes/deviations
  • Supports the implementation of 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 improvementEstablishes relationships with R&D QA and other global Quality functions:
    • Advises R&D on applicable requirements, partnering with more senior members in R&D QA for complex issues
    • Acquires 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 marketsHelps maintain the Quality System in R&D
      • Identifies and escalates risks to compliance to senior management
      • Provides QA support and assists R&D in use of existing systems to manage documentation, changes, deviation investigation, CAPA, internal audit processes, commitments to Health Authorities
      • Supports internal audits and helps prepare for regulatory inspections
      • Supports inspection finding responses related to applicable area of oversight
      • Supports the provision of accurate and timely reports on metrics, findings, risks and trendsMinimum Requirements:
        • Bachelor's degree in a scientific discipline / Life Sciences required (e.g., Biology, Microbiology, Chemistry or Pharmacy). Masters or PhD preferred.
        • 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.
        • Experience working across different market areas and different phases of R&D preferred (Product Development/ GLP Toxicology, Clinical Phase 1, 2 and 3 and commercialization)
        • Requires conceptual and practical expertise in QA oversight of R&D work (non-regulated, GLP and preparation for GMP tech transfer)
        • Demonstrated leadership capabilities in ethics and values, integrity and trust, decision quality, functional/technical skills, peer relationships, and problem solving
        • Experience in biopharmaceutical development either as a technical expert or providing QA oversight in one or more of various disciplines including (but not limited to) Analytical, Molecular Biology, Virology, Cell Culture, Purification, Drug Product
        • Effective delivery of objectives in a complex matrix environment and ability to deal with rapid change
        • Effective verbal & written communication skills in a cross functional environment with attention to detail
        • Ability to present solutions to complex and strategic issues
        • Evidence of commercial awareness in technical strategies
        • Excellent customer focus with demonstrated management of customer expectations
        • Effective presentation skillsAbout UsOur BenefitsSeqirus 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 SeqirusSeqirus 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 usAs a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at Seqirus.Do work that matters at Seqirus!

Keywords: CSL Behring, Cary , Sr Specialist, R&D Frontline QA, Other , Holly Springs, North Carolina