Senior Quality Specialist, Project QA, CQV

CSL; Kankakee (IL); Vor Ort; USD 76.000 - 95.000; Vollzeit

Zusammenfassung

CSL Behring is expanding its Kankakee site to support Ig production through M7/8 CQV activities. This role provides quality oversight for commissioning and qualification of the new facility, ensuring GMP-compliant planning, SOP maintenance, and document control.

You will also support inspections, change controls, and CQV document approvals. The ideal candidate has 5+ years in quality/GMP, with strong regulatory knowledge across GxP frameworks and experience in biologics manufacturing.

Qualifikationen

• 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.

Aufgaben

• Ensuring GMP-compliant planning and implementation of M7/8
• Maintains GMP-related quality systems including 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 regulatory inspections, self-inspections and customer audits.
• Supports local & global change requests related to CQV activities
• Reviews and approves all CQV documents including risk assessments, URSs, CQV protocols and reports.

Kenntnisse

GxP knowledge

Quality assurance

Regulatory compliance

CQV oversight

Interpersonal communication

Ausbildung

Degree in relevant scientific discipline (Pharmacy, Chemistry, Biology, Biochemistry)

Jobbeschreibung

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.

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

The expected base salary range for this position at hiring is $76,000 - $95,000. Please note this salary range reflects the minimum and maximum base pay that CSL expects to pay for this position at the listed location as of the time of this posting. Individual base salary for a successful candidate is determined by qualifications, skill level, experience, competencies and other relevant factors. In addition to base salary, total compensation for this role may also include incentive compensation and equity.

Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.