QAO Specialist II
- Full-Time
- Kankakee, IL
- CSL Behring
- Posted 3 years ago – Accepting applications
Job Description
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 the second largest influenza vaccine company 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!
Provides oversight for development and maintenance of quality programs, systems, processes and procedures to ensure compliance with company standards and regulatory guidelines. Leads preparation for audits/inspections and resolution of findings; liaises with auditing groups and inspectors throughout audits. Coordinates legal requests in support of government investigations or litigations. Ensures quality assurance programs and policies are maintained and modified regularly. Facilitates uniform standards worldwide, sharing of best practices, and achievement of the company's mission globally.
Responsibilities
Under direct supervision, supports Quality Assurance activities to ensure compliancewith company and cGMP standards
Participates in investigation meetings with responsible department and any requiredsupport group(s)
Performs inspections and maintains quality records for analysis of raw materials,materials in process, and finished products
May conduct internal audits including audits of regulatory submissions
Assists in preparation for regulatory and customer inspections and participates ininspections to ensure quality standards
Executes training/awareness related to investigation and GMP changes to production team
Qualifications
Bachelor degree in a relevant scientific discipline (Pharmacy, Chemistry, Biology,Biochemistry)
0-2 years' experience working in a cGMP regulated environment
Worker Type:
Employee
Worker Sub Type:
Regular
Apply to this Job
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 the second largest influenza vaccine company 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!
Provides oversight for development and maintenance of quality programs, systems, processes and procedures to ensure compliance with company standards and regulatory guidelines. Leads preparation for audits/inspections and resolution of findings; liaises with auditing groups and inspectors throughout audits. Coordinates legal requests in support of government investigations or litigations. Ensures quality assurance programs and policies are maintained and modified regularly. Facilitates uniform standards worldwide, sharing of best practices, and achievement of the company's mission globally.
Responsibilities
Under direct supervision, supports Quality Assurance activities to ensure compliancewith company and cGMP standards
Participates in investigation meetings with responsible department and any requiredsupport group(s)
Performs inspections and maintains quality records for analysis of raw materials,materials in process, and finished products
May conduct internal audits including audits of regulatory submissions
Assists in preparation for regulatory and customer inspections and participates ininspections to ensure quality standards
Executes training/awareness related to investigation and GMP changes to production team
Qualifications
Bachelor degree in a relevant scientific discipline (Pharmacy, Chemistry, Biology,Biochemistry)
0-2 years' experience working in a cGMP regulated environment
Worker Type:
Employee
Worker Sub Type:
Regular