Specialist/Sr. Specialist QC (Analytical Science & Technology)
- Employer
- CSL Behring
- Location
- Holly Springs, North Carolina
- Start date
- Jul 10, 2021
View more
- Discipline
- Information Technology, Business/Data Analytics, Quality
- Required Education
- Bachelors Degree
- Position Type
- Full time
Job Details
With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.
CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL’s therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.
We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!
Job Purpose
Reporting to the Analytical Science and Technology Sr. Manager in Holly Springs. The role is accountable for Quality Control method validation lifecycle management, method development and method standardization/robustness. The validation specialist is an SME in testing methodology, able to troubleshoot technical issues, develop current and existing methods and be current with the latest analytical testing technologies. The role requires the execution of intra site method transfers and SME input into regulatory filings/audits and investigations. Responsible for experimental design on key projects that involve new technologies and processes to QC. The employee is required to review data generated from validation activities and bring to the attention of Management any detrimental trend or deviation identified.
Major Accountabilities:- Complies with policies and procedures in order to maintain compliance with legal regulations, health and safety, and regulatory requirements as written
- Participates preventive action & continuous improvement programs to reduce operating costs
- Leads cross-training to support staff availability within QC department
- Owns, develops, and maintains methods and GSOPs
- Subject matter expert in assigned assays/techniques
- Writes applicable protocols and reports
- Leads method transfers, validations and verifications
- Owns/authors deviation and invalid assay assessments
- Performs peer review of data as required
- Plans and schedules routine operations with QC
- Attends project related meetings as departmental representation as required
- Participation in quality risk assessments
Bachelor’s degree in related scientific field
6+ years of laboratory experience OR 6+ years with advanced degree OR equivalent related to Virology
Experience within virology lab
Knowledge of GMPs, safety regulations and data integrity
Knowledge of method validation and transfer with in depth understanding of requirements, preferably related to Virology
Ability to communicate technical knowledge
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
- Phone
- 610-878-4000
- Location
-
1020 First Avenue
King of Prussia
Pennsylvania
19406
United States
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