With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.
CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL’s therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.
We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!
Supervisor of 2 shifts of Quality Assurance professionals that provide on the floor support to manufacturing, laboratories, utilities, maintenance, and logistics. Provides technical support for the US Holly Springs site in all cGMP compliance related matters, including assurance that all aspects comply with cGMPs, regulatory requirements, the Quality Manual, and site SOPs. Supervises the activities and development of direct reports.
The weekend shifts cover Saturday 7am-Tuesday 7am in 12-hour increments, 7 to 7. The Supervisor, Front Line Quality Assurance (FLQA) will support their team during these hours with on-site support divided between the 2 shifts along with time dedicated to ensuring connectivity to the priorities and initiatives at the site.
Example schedules include: 2pm-12pm Friday-Monday or 1pm-1am Saturday-Monday with 4 hours allocated during business hours. Schedule flexibility will be considered when defining core hours for this role that balance personal preference and the needs of the team.
- Supervise a staff of QA Specialists (exempt level professional employees).
- Provide daily prioritization/workload allocation, coaching/mentoring on issue triage, and employee performance management.
- Ensure proper staffing, training, and development of team to support 24/7 operations.
- Develop, measure, and respond to team KPIs along with other FLQA Supervisors projects.
- Apply knowledge of regulatory requirements for pharmaceutical, biotech and vaccine industries.
- Ensures collaboration of the FLQA team with other functions and departments.
- Professional development of direct reports, through coaching, mentoring, and development.
- As needed to support team workload, performs the following FLQA core tasks:
- Perform real time batch record/logbook review.
- Perform routine quality walkthroughs in manufacturing.
- Support quality systems related to QA for in-process sampling and controls and all aspects of FLQA.
- Act as quality representative on the floor during manufacturing operations and troubleshooting.
- Provide quality oversight of site critical alarm reports and corrective maintenance program.
- Support the development and revision of SOPs and batch records.
- Perform activities related to change controls, writing deviations and investigations using electronic enterprise systems – Trackwise, SAP, LIMS, etc.
- Bachelor’s degree in related engineering or scientific field required.
- Minimum of 5 years’ relevant experience within the biopharmaceutical industry with experience in biotechnology and aseptic processing
- Demonstrated knowledge of GMPs and FDA requirements
- 2+ years Quality Assurance experience in a FDA regulated environment preferred
- 2+ years of supervisory experience or demonstrated leadership role preferred
- Previous experience directly operating or supporting a Bulk/API, Formulation, Filling, or Packaging process
- Strong technical understanding of the production processes used in the pharmaceutical/biotechnology industry