Specialist I/II, QA (Fill Finish Expansion) 4th Shift

About CSL

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!

Job Description

Job Purpose

The Specialist will be a member of the Quality Operations team responsible for Quality Assurance oversight of the Holly Springs Fill Finish Expansion (FFE) project. The Specialist will help provide strategic and technical expertise for the US FCC expanded Fill Finish facility with full GMP compliance to both US and EU regulations.

Hours: 4th Shift: Saturday-Monday 7:00am-7:00pm

Some extended hours may be required during specific phases of the project.

For training , this role will require the individual to work Monday-Friday; standard business hours.

Once trained, the individual will move to their designated shift.

The Fill Finish Expansion Project is a $140-million expansion of Seqirus' Holly Springs, NC, manufacturing facility. The expansion allows Seqirus to increase capacity for formulation, fill, and finish manufacturing of cell-based and adjuvanted influenza vaccines for global markets and will create 120 permanent highly skilled jobs, adding to the current workforce at the site of more than 600 employees.

Responsible for Quality Assurance oversight to ensure the facility is built and released according to GMP regulations and procedures.

This role will work collaboratively with all relevant departments on operational readiness activities needed to ensure that the Expansion is GMP ready. Core responsibilities include providing quality oversight related to the process, equipment, and business systems that drive strategic improvements within Fill Finish.

This position will provide front line quality assurance support and oversight on production and process-specific issues for the expansion. This position will conduct QA activities for the project including review/approval of project documentation as well as the responsibility for training other members of their shifts on the FLQA commercial support of the FFE operations.

Major Accountabilities:

• Support the Fill Finish Expansion Project by providing QA oversight for technical and operational equipment/process issues.
• Ensure that equipment works to its specification and capacity and is in compliance with all GMP regulations.
• Work with the FFE team in identifying and implementing continuous improvement projects to improve yield, reliability, process robustness, and safety, as applicable.
• Assist with the QA oversight of the enrolling, commissioning, and qualification of new materials and equipment.
• Responsible for training other members of their shift on the FLQA commercial support
• Work with cross functional leads of the project to establish recommended QA oversight and guidelines.
• Provide QA oversight (review and approval) of manufacturing documentation (procedures, batch records, training materials, specifications, etc.).
• Work with Manufacturing (MFG), Engineering and Front Line QA (FLQA) teams to ensure the expansion areas and the current Fill Finish operations have consistent policies and procedures.
• Aid in the review and approval of all relevant documents to ensure full GMP release of the areas within scope of the project in alignment with the project timeline.
• Assist in developing and training employees in SOPs, GMPs and OJTs as they relate to the Expansion Project to ensure training effectiveness.
• Support the work order, deviation and corrective action programs as it relates to the Fill Finish Expansion Project as needed.
• Establish/maintain knowledge of the current Manufacturing Fill Finish Operations and FLQA processes and procedures in order to bring continuity to the FFE project. This individual is to work towards continued alignment of the current MFG Fill Finish Operations and the delivery of the new line to the Fill Finish area.
• Ensure production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.
• Perform activities related to authoring and reviewing work flows, writing deviations and investigations, and using electronic enterprise systems Trackwise, SAP, LIMS, EDMS, etc.
• Perform real time documentation (batch record, logbook, etc.) review concurrent with manufacturing operations on the manufacturing floor.
• Perform routine quality audits in Manufacturing.
• Review and assess quality system information (i.e. alarm reports, work orders)
• Support quality systems related to QA for in-process sampling and controls, and all aspects of shop floor QA.
• Support the development and/or revision of SOPs and batch records.

Minimum Qualifications:

• Bachelor's degree in Science / Engineering discipline preferred or equivalent experience in the biotechnology or pharmaceutical industry
• Minimum of 3 years in Quality Assurance and/or in a GMP regulated environment within the pharmaceutical industry required.
• Direct experience with regulated environments (i.e. cGMP, OSHA, EPA) required.
• Previous experience directly supporting MFG and/or MFG experience in Aseptic Filling/Inspection/Packaging operations with technical understanding of the production processes used in the pharmaceutical or biotechnology industry is required.
• Experience in the delivery of a new GMP facility, i.e. Delivery of requirement, acceptance testing, qualification, and validation, strongly preferred.