QC Microbiology Specialist
Company: CSL Behring
Location: Holly Springs
Posted on: August 7, 2022
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
- 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
- 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
- You will lead harmonization efforts with other Seqirus site
- 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
- 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
- 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
- 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
- Bachelor's degree and 3+ years' experience or equivalent
- 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
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