QC Microbiology Specialist

Company: CSL Behring
Location: Holly Springs
Posted on: August 7, 2022

Job Description:

Job DescriptionQC Specialist Job Purpose:Reporting to the Manager of Quality Control, the QC Specialist provides Technical SME guidance in the Quality Control Department at 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:

• You will lead 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. - (50% of work time dedicated to this accountability)
• Technical SME for all assays and equipment. You will support all analysts in the relevant laboratory with troubleshooting, assisting with equipment breakdowns, and assessing new equipment implementation.
• You will assist with training of Analysts in the laboratory as relevant laboratory assay SME.
• You will be the liaison between AS&T and relevant laboratory to assist with and perform method validations/verifications.
• You will lead harmonization efforts with other Seqirus site relevant laboratories.
• 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, 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.
• You will 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 requiredAbout UsOur BenefitsSeqirus 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 you can participate in when you join Seqirus.About SeqirusSeqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about .We want Seqirus to reflect the world around usAs a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about at Seqirus.Do work that matters at Seqirus!

Keywords: CSL Behring, Cary , QC Microbiology Specialist, Other , Holly Springs, North Carolina