Onsite Commercial QA Specialist - GMP Batch Release

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

Benefits offered by this job

Competitive PTO

8 paid holidays

Medical, dental, vision benefits from

Tuition reimbursement

Job summary

Catalent's Kansas City facility is seeking a Commercial Manufacturing Quality Assurance Specialist to support quality operations by reviewing batch records, ensuring FDA/GXP compliance, and maintaining product quality. This onsite, M-F role in Kansas City, MO offers opportunities to contribute to continuous improvement and collaborate across cross-functional teams.

Join a science-driven environment focused on quality and regulatory excellence, with training and career growth within Catalent's

Qualifications

• Master’s degree in a scientific discipline with no experience, or Bachelor’s degree in a scientific discipline with 1+ years in QA/QC/regulatory compliance in GMP.
• Six Sigma or ASQ certification preferred.
• Perform batch record review, product release, and disposition.

Responsibilities

• Perform batch record review, product release, and disposition.
• Draft, review, and approve technical documents such as procedures or master batch records.
• Ensure products are manufactured, tested, and released per FDA guidelines, GXPs, and SOPs.
• Develop and maintain quality assurance programs, procedures and controls to meet standards and guidelines.
• Provide quality assurance advisement for projects and customer interactions.
• Support process-related improvements and manufacturing floor activities.

Skills

Quality Assurance

Quality Control

Regulatory Compliance

Education

Bachelor’s in science

Master’s in science

Associate’s in science

High school diploma with FDA-regulated field experience

Job description

Catalent's Kansas City facility is seeking a Commercial Manufacturing Quality Assurance Specialist to support quality operations by reviewing batch records, ensuring FDA/GXP compliance, and maintaining product quality. This onsite, M-F role in Kansas City, MO offers opportunities to contribute to continuous improvement and collaborate across cross-functional teams.

Join a science-driven environment focused on quality and regulatory excellence, with training and career growth within Catalent's