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Analyst II/III, QC -Stability Coordinator

Employer
CSL Behring
Location
Holly Springs, North Carolina
Start date
May 13, 2022

View more

Discipline
Clinical, Clinical Project Management, Quality
Required Education
Bachelors Degree
Position Type
Contract

Job Details

Job Description

Job Purpose:

Assist with authoring and executing Stability protocols.

Performs associated tasks without errors per applicable SOPs and protocols.

Complies with policies and procedures in order to maintain compliance with legal regulations, health and safety, and regulatory requirements as written.

Assist in distribution of all samples destined for various QC labs on 24/7 basis. This includes scheduling and performing timepoint pulls for stability.

Responsible for ordering and inventory control for glassware and sterile supply to the various QC labs.

Major Accountabilities:

  • Support LIMS builds for stability studies.
  • Support minor SOP writing and revisions.
  • Support third party contract lab shipping of QC samples and receipt of incoming samples.
  • Operate the QC Parts washer and autoclave. Maintain Temperature controlled chambers.
  • Perform sample aliquoting in a Biosafety cabinet using aseptic technique
  • Support inventory control of all retain, reference and reserve samples, including stability samples.
  • Support for timely and effective investigation of area DR’s
  • Support entering all required data into LIMS (materials, projects, products, testing)
  • Specific training requirements to be determined by functional manager depending on activities assigned.
  • Participates in preventive action & continuous improvement programs to reduce operating costs
  • Participates in cross-training to support staff availability within QC department

Minimum Qualifications:

  • Bachelor’s degree in Scientific discipline or associate’s degree and 3+ years of industry experience or equivalent.
  • 1+ years of directly related laboratory experience OR equivalent.
  • Understanding of ICH Guidelines as they pertain to Stability Studies and programs
  • Technical Writing Skills
  • Sample collection/distribution/testing/shipment. Performing Stability timepoint pulls
  • Knowledge of GMPs, safety regulations and data integrity preferred.
  • GMP documentation in a production environment
  • Use of electronic document management systems
  • Proficiency in use of LIMS systems
  • Material receipt and inventory control
  • Glass washing activities and restocking of supplies
  • Aseptic technique and sample manipulation in a Biosafety Cabinet

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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