Pharma Compliance Specialist III – GMP & Documentation

Catalent; Kansas City (MO); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Medical, dental, and vision benefits

8 paid holidays

Tuition reimbursement

Job summary

Catalent’s Kansas City facility is seeking a Compliance Specialist III to support the preparation, review, and approval of technical and regulatory documentation onsite in Kansas City, MO. You will ensure compliance with current Good Manufacturing Practices and internal procedures, contributing to high-quality pharmaceutical operations.

Key responsibilities include authoring and reviewing protocols and batch records, maintaining lab notebooks, and ensuring readiness for on-site clients within a

Qualifications

• Bachelor’s degree in a related field or equivalent regulated-industry experience.
• Strong ability to prepare, review, and approve regulatory documents.
• Experience ensuring compliance with current Good Manufacturing Practices.

Responsibilities

• Author and approve technical documents such as protocols, reports, and SOPs.
• Review documents for accuracy and regulatory compliance.
• Review batch records for GMP conformance to SOPs and protocols.
• Draft batch records for use by pharmaceutics and operations personnel.
• Draft SOPs for processes used by pharmaceutics and operations personnel.
• Perform spot-checks of experimental areas and track lab notebooks.
• Track and trend batch record initiation, approvals, updates, and feedback after execution.
• Maintain readiness for on-site clients.
• All other duties as assigned.

Skills

Bachelor's degree

Microsoft Word

Microsoft Excel

Attention to detail

Regulatory compliance

Documentation

Education

Bachelor's Degree

Tools

Microsoft Word

Microsoft Excel

Job description

Catalent’s Kansas City facility is seeking a Compliance Specialist III to support the preparation, review, and approval of technical and regulatory documentation onsite in Kansas City, MO. You will ensure compliance with current Good Manufacturing Practices and internal procedures, contributing to high-quality pharmaceutical operations.

Key responsibilities include authoring and reviewing protocols and batch records, maintaining lab notebooks, and ensuring readiness for on-site clients within a