Senior Quality Specialist, Project Quality, CSV

CSL Behring•Kankakee, IL

5d•Onsite

About The Position

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 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.

Requirements

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

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.