Specialist, R&D Frontline QA
This position in R&D QA provides frontline QA oversight of bulk and fill finish manufacturing activities for clinical trial material produced in Holly Springs, NC and related changes and deviations. Provides support in Holly Springs for assuring quality during GMP clinical manufacturing activities. As required also supports the R&D QA batch disposition teams.
Provide Quality oversight of R&D 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
Reviews executed batch records, development/validation/qualification protocols for compliance and completeness.
Ensures data integrity by checking information back to source in reports, product specification file (PSF), regulatory filings etc. to ensure compliance and completeness.
Coordinates approval of documents to support batch release activities with Clinical Batch Dispo and commercial QA/Qualified Person (QP)
Supports the development and implementation of standard operating procedures (SOPs), work instructions and batch production document(s) governing GMP production and QA oversight activities
Identifies non-compliances with GMP production of bulk and semifinished material and reports as appropriate.
Performs minor deviations investigations and product technical compliant investigatons
As needed supports R&D QA batch disposition activities
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 Organisations, and identified areas for continuous improvement
Establishes relationships with R&D QA and other global Quality functions:
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 markets
Helps 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 trends
Bachelor’s degree in a scientific discipline / Life Sciences required (e.g., Biology, Microbiology, Chemistry or Pharmacy)
0+ years in Quality Assurance and/or in a GxP regulated environment within the pharmaceutical industry
Previous work in a QC, Research, Development, Manufacturing or Quality perferred
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