Senior Quality Specialist, Project Quality, CSV

The growing demand for an expanding production line requires an expansion of CSLs manufacturing capacity. To support this growth immunoglobulin (Ig) production activitiesfrom plasma thawing through sterile fillingwill 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 for computerized systems.

The position partners closely with colleagues in Technical Operations IT and Global Engineering for Ig expansion project (M7/8) to ensure consistent application of quality principles systems and documentation standards. A key responsibility is to ensure alignment globally in processes documentation and execution.

RESPONSIBILITIES

• Ensuring GMP-compliant planning and implementation of M7/8 for CSV.
• Maintains GMP-related quality systems including standard operating procedures (SOPs) and supportive systems to ensure cGMP compliance.
• Reviews and approves standards and procedures governing CSV quality systems and processes. Supports document management change control deviation handling and supplier qualification.
• Supports all regulatory inspections self-inspections and customer audits.
• Ensures IT/ExS procedures and tools accurately integrate and align with computerized system validation (CSV) requirements.
• Reviews and approves all CSV documents that include but are not limited to risk assessments URSs protocols and reports.
• Provides QA oversight and approval of project and operational changes deviations and investigations involving GxP Computerized Systems including approval of CAPA plans and subsequent tracking of implementation aligned actions.

QUALIFICATIONS

Education

• Degree in relevant scientific discipline or related (Pharmacy Chemistry Biology Biochemistry).

Experience

• 5 years experience in Quality IT or Validation.
• Pharma/Biotech or similarly regulated environment experience desirable.
• Experience in Quality Assurance IT Quality Control Validation Production or Regulatory Affairs.
• Knowledge of GxP GAMP FDA and EMA requirements specifically CFR21 part11 and Annex 11.

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 $76000- $95000. 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 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.

About CSL Behring

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients needs by using the latest technologies we discover develop and deliver innovative therapies for people living with conditions in the immunology hematology cardiovascular and metabolic respiratory and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation recombinant protein technology and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the worlds largest plasma collection networks CSL Plasma. Our parent company CSL headquartered in Melbourne Australia employs 32000 people and delivers its lifesaving therapies to people in more than 100 countries.

To learn more about CSL CSL Behring CSL Seqirus and CSL Vifor visit and CSL Plasma at Benefits

For more information on CSL benefits visit How CSL Supports Your Well-being CSL .

You Belong at CSL

At CSL Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy we are able to better understand and connect with our patients and donors foster strong relationships with our stakeholders and sustain a diverse workforce that will move our company and industry into the future.

To learn more about inclusion and belonging visit Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process please visit Experience:

Senior IC