Senior Quality Specialist, Project QA, CQV
CSL
Summary
The growing demand for an expanding production line requires an expansion of CSL's manufacturing capacity. To support this growth, immunoglobulin (Ig) production activities—from plasma thawing through sterile filling—will be incorporated into the new Building under construction at the CSL Kankakee (KAN) site to accommodate Ig production. The new fill-finish facility is part of the Ig manufacturing expansion, known as Module (M) 7/8.
Job description
This role will provide Quality oversight for the Commissioning and Qualification activities associated with the M 7/8 Site Expansion Project at the CSL Behring Kankakee site.
Responsibilities
- Ensuring GMP-compliant planning and implementation of M7/8
- Maintains GMP-related quality systems including standard operating procedures (SOPs) and supportive systems to ensure cGMP compliance.
- Reviews and approves standards and procedures governing CQV quality systems and processes. Supports document management, change control, deviation handling, and supplier qualification.
- Supports all regulatory inspections, self-inspections and customer audits.
- Supports local & global change requests related to CQV activities
- Reviews and approves all CQV documents that include but are not limited to risk assessments, URSs, CQV protocols and reports.
Qualifications
Education
- Degree in relevant scientific discipline, or related (Pharmacy, Chemistry, Biology, Biochemistry)
Experience
- 5 years' experience in quality/GMP in the pharmaceutical/biotech industry.
- Demonstrates experience in quality assurance and regulatory compliance.
- with GxP, FDA, TGA, EU, and other regulatory agency guidelines and in
- manufacturing of biologics.
- Experience in quality oversight of GMP-compliant commissioning and
- qualification of production facilities, equipment, and cleanrooms.
- Strong quality process knowledge.
- Engineering experience desirable.
Competencies
- Knowledge of GMP, FDA, EU and other relevant GxP regulations
- Effective communication skills
- Good organizational and interpersonal skills
- Collaborate effectively with internal and external employees and
- stakeholders
Requirements
- Degree in relevant scientific discipline, or related (Pharmacy, Chemistry, Biology, Biochemistry)
- 5 years' experience in quality/GMP in the pharmaceutical/biotech industry
- Demonstrates experience in quality assurance and regulatory compliance
- Knowledge of GxP, FDA, TGA, EU, and other regulatory agency guidelines
- Experience in manufacturing of biologics
- Experience in quality oversight of GMP-compliant commissioning and qualification of production facilities, equipment, and cleanrooms
- Strong quality process knowledge
- Engineering experience desirable
- Effective communication skills
- Good organizational and interpersonal skills
- Collaborate effectively with internal and external employees and stakeholders
Benefits
- Incentive compensation
- Equity
Company overview
CSL Limited is an Australian multinational specialty biotechnology company that researches, develops, manufactures, and markets products to treat and prevent serious human medical conditions. Founded in 1916 as Commonwealth Serum Laboratories, CSL has grown to become the world's fifth largest biotechnology company with operations in over 35 countries. The company specializes in blood plasma derivatives, vaccines, antivenoms, and cell culture reagents used in medical and genetic research applications. CSL operates through several key divisions including CSL Behring (focusing on rare and serious diseases), CSL Seqirus (one of the world's largest influenza vaccine providers), CSL Plasma, and CSL Vifor. With over 32,000 employees globally, CSL maintains a strong R&D pipeline and has invested over US$3.3 billion in research and development over the past five years. The company is publicly traded on the Australian Securities Exchange and has its global headquarters in Parkville, Melbourne, Australia.