Specialist, QC (Immunology)

Provides Technical SME support in the Quality Control Department at CSL Seqirus of the relevant laboratory for Assays and Equipment, Compliance Records, Regulatory Audits, Deviation Management, CAPAs, Work Orders, Reports, Trends/Metrics and Document Creation/Revisions.

Major Accountabilities:

• Technical SME for all assays and equipment. Analyst must have experience in areas including immunological assay (SRID, Ouchterlony), SDS-Page, UV-Vis, PCR, Cell-based assays/techniques including cell passaging, or viral titers.
• Supports all Analysts in the relevant laboratory with troubleshooting, assisting with equipment breakdowns, and assessing new equipment implementation.
• Assist with training of Analysts in the laboratory as relevant laboratory assay SME.
• Be liaison between multiple internal organizations and relevant laboratories to assist with and perform method validations/verifications.
• Leads deviation (DR) investigations to adequately identify root cause and implement appropriate corrective and preventative actions (CAPAs) to prevent reoccurrence and serve as QC liaison with other department investigation writers to ensure complete and timely resolution. Employs standardized root cause analysis, investigation tools and methodologies.

• Participates in continuous improvement programs/gemba kaizen events to eliminate non-value add activities/maximize efficiency.
• Provides support with assigned business process systems (e.g. SAP, LIMS, EDMS, LMS, TrackWise, Veeva etc.).
• Responsible for the Work Order Tracking system for tracking and coordinating the initiation, execution and completion of work orders.
• SME input on QC Change Control Evaluation and Implementation Actions, Corrective Actions /Preventative Actions (CAPAs) and Document revision/Periodic Review workflows to support the Quality Control department.
• Complies with policies and procedures to maintain compliance with legal regulations, health and safety, and regulatory requirements as written.
• Responsible for reviewing and analyzing trend reports to identify areas requiring additional action (e.g. quarterly reports, APQR, invalids, OOS/OOT).
• Assist in departmental metrics and key performance indicators (KPIs) by attendance through QCOLT for Senior leadership review.
• Be the relevant laboratory’s technical SME during regulatory and self-inspection audits according to all cGMP regulatory (e.g. USP/EP) and Seqirus Quality Manual requirements.

Minimum Qualifications:

• Bachelor’s degree and 3+ years’ experience or equivalent (minimum)
• Basic knowledge of cGMP and FDA requirements preferred
• Knowledge of Laboratory Systems and Investigation/Deviation/CAPA writing is desirable
• Excellent organizational, planning and time management skills.
• Strong oral, written and interpersonal communication skills. Demonstrated technical writing skills.
• The ability to work effectively in both a team environment and an individual contributor role.

Our Benefits

CSL Seqirus 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 CSL Seqirus.

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.

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