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Specialist, QC (Microbiology)

Employer
CSL Behring
Location
Holly Springs, North Carolina
Start date
Mar 18, 2023

View more

Discipline
Quality, Quality Control, Science/R&D, Microbiology
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Best Places to Work

Job Details

Job Description

Job Summary:

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. 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 AS&T and relevant laboratory to assist with and perform method validations/verifications.
  • Leads harmonization efforts with other Seqirus site relevant laboratories.
  • 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, 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 required
  • 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.

About Us

Our Benefits

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 Seqirus.

About Seqirus

Seqirus 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 Seqirus.

We want Seqirus to reflect the world around us

As a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at Seqirus.

Do work that matters at Seqirus!

Company

As the third largest global biotechnology company with employees in more than 35 countries, CSL Behring is focused on serving patients with serious and rare diseases, including coagulation disorders, primary immune deficiencies, hereditary angioedema, respiratory disease and neurological disorders. We collaborate with patient and biomedical communities to improve access to therapies, advance scientific knowledge and support future medical research. 


CSL Behring's dynamic environment fosters innovation and attracts the best and brightest who share a commitment to helping save lives. People here are free to live their Promising FUTURES where they can fulfill their individual career aspirations and realize their potential. 


CSL Behring is committed to diversity and inclusion, both of which underpin our Values of patient focus, innovation, collaboration, integrity and superior performance. We believe that by harnessing and honoring the unique capabilities, experiences and perspectives of our people, we are better able to serve our patients.


CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. The parent company, CSL Limited, headquartered in Melbourne, Australia, employs more than 27,000 people, and provides its life-saving medicines in more than 70 countries. 
For more information visit www.cslbehring.com. Help us deliver on our promise to save lives and protect the health of people around the world. Promising FUTURES start at CSL Behring!

Stock Symbol: CSL

Stock Exchange: Australian Securities Exchange

Company info
Phone
610-878-4000
Location
1020 First Avenue
King of Prussia
Pennsylvania
19406
United States

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