Do you want to work with a company that tackles fascinating problems and find solutions to complex challenges? CSL 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 CSL 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.
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You will report to the Associate Director, Product Development and Research Quality and will work onsite at our CSL Seqirus location in Holly Springs, NC. You will provide frontline QA oversight of bulk and fill finish manufacturing activities for clinical trial material produced in Holly Springs, NC and related changes and deviations. Provide support in Holly Springs for assuring quality during GMP clinical manufacturing activities. You will also supports the R&D QA batch disposition teams, and development and early phase laboratories. Benefits Include an annual bonus, Onsite Café, walking trail and other outdoor amenities, Medical, Dental, Vision, Life Insurance, 401K with a 6% match, and PTO available from your first day of hire.
Responsibilities
- Provide QA oversight on the shop floor to the manufacture and distribution of products for clinical trials in Holly Springs, including sterile manufacturing and liaising with BPD (Biopharmaceutical Process Development), Operations, QC, sterility assurance etc.
- Provide QA oversight of Formulation, aseptic operations, inspection and packaging activities
- Review executed batch records, development/validation/qualification protocols for compliance and completeness.
- Ensure data integrity by checking information back to source in reports, product specification file (PSF), regulatory filings etc. to ensure compliance and completeness.
- Coordinate approval of documents to support batch release activities with Clinical Batch Dispo and commercial QA/Qualified Person (QP)
- Help develop and implement standard operating procedures (SOPs), work instructions and batch production document(s) governing GMP production and QA oversight activities
- Identify non-compliances with GMP production of bulk and semifinished material and reports.
- Perform and approve minor deviations investigations and product technical compliant investigations
- 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
- Establish relationships with R&D QA and other global Quality functions:
- Acquire and maintain knowledge of Seqirus SOPs and Policies, regulatory requirements and guidance (e.g., Good Laboratory Practice, Good Manufacturing Practice, Quality by Design), 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
- Help maintain the Quality System in R&D by identifying and escalating 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
Minimum Qualifications
- Bachelor's degree in a scientific discipline / Life Sciences required (e.g., Biology, Microbiology, Chemistry or Pharmacy)
- 2+ 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 preferred
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.
Do work that matters at CSL Seqirus!
Watch our 'On the Front Line' video to learn more about CSL Seqirus