Specialist - Quality Assurance Operations, Client Quality

Specialist I – Quality Assurance (Client Quality)

Location:

Madison, WI |

Work Schedule:

Monday–Friday 8 am–5 pm | 100% on‑site

The Quality Assurance team at Catalent is responsible for ensuring compliance with FDA, EMA, ICH, and company internal standards. The role involves oversight of quality systems, deviations, CAPAs, change controls, document control, supplier quality management, raw material testing, equipment calibration, validation, and audit preparation. This position supports manufacturing operations and regulatory inspections.

• Represent QA in complex Deviations, Change Controls, CAPAs, and investigations.
• Lead continuous improvement projects for the QA Operations department.
• Review Master Batch Production Records and material specifications for prepared solutions and columns.
• Oversee control and management of Cell Bank inventory.
• Review and approve protocols and associated reports supporting manufacturing operations.
• Review and approve deviation investigation records.
• Provide training to QA and manufacturing personnel on QA topics.
• Consult and guide manufacturing personnel on execution of the Quality Management System.
• Oversee routine manufacturing operations: QA on the floor, issuance of controlled documents, review of CGMP documentation, and disposition of prepared solutions and columns.
• Notify management of potential quality or regulatory issues affecting product quality or compliance.
• Perform other assigned duties.

• Doctorate or Master’s Degree in a STEM discipline (minimum 0 or 4 years of related experience respectively) or Bachelor’s Degree in STEM (minimum 6 years) or Associate’s Degree in STEM (minimum 10 years).
• Ability to use Microsoft Excel, Word, and other office systems.
• Prior experience with quality management software such as Track Wise® or Compliance Wire®.
• Independently apply CGMPs in daily work.
• Maintain data integrity and ensure compliance with SOPs, specifications, cGMP, ICH, FDA, and EMA regulations or guidelines.
• Execute procedures of high complexity with high quality.
• Advanced understanding of pharmaceutical laboratory and/or production operations.

• 152 business‑day paid time off plus 8 paid holidays.
• Generous 401(k) match.
• Medical, dental, and vision benefits effective on day one.
• Tuition reimbursement.

Catalent is an Equal Opportunity Employer, without regard to disability or veteran status. If you require reasonable accommodation for any part of the application or hiring process due to a disability, please email Disabili with the job number, title, and location.