Onsite QA Specialist - Commercial Manufacturing

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

Benefits offered by this job

Paid time off

8 paid holidays

Tuition reimbursement

Medical, dental, vision benefits day 1

Job summary

Catalent Kansas City is seeking a Commercial Manufacturing Quality Assurance Specialist to support quality operations by reviewing batch records, releasing products, and ensuring adherence to FDA guidelines and GXPs in a fast-paced, science-driven environment.

The role involves cross-functional collaboration, training and mentoring, and contributing to continuous improvement initiatives while upholding internal standards and regulatory requirements.

Qualifications

• Bachelor's or higher in a scientific field with 1+ year QA/QC in GMP.
• Six Sigma or ASQ certification preferred.
• Experience reviewing batch records and ensuring product release.

Responsibilities

• Perform batch record review, product release, and disposition.
• Draft, review, and approve technical documents and master batch records.
• Ensure compliance with FDA guidelines, GXPs and SOPs.
• Develop and maintain QA programs, procedures and controls.
• Train, coach and mentor others on technical or business issues.
• Assist in data compilation for the annual product review.
• Provide QA advisement for project outcomes and customer interactions.
• Participate in process-related improvements and facility compliance.

Skills

Six Sigma

ASQ certification

Education

Master’s degree in a scientific discipline

Bachelor’s degree in a scientific discipline with 1+ years QA/QC/Regulatory in GMP

Associate’s degree with 3+ years FDA-regulated experience and 1+ QA/QC

High school diploma with 5+ years FDA-regulated experience and 1+ QA/QC

Job description

Catalent Kansas City is seeking a Commercial Manufacturing Quality Assurance Specialist to support quality operations by reviewing batch records, releasing products, and ensuring adherence to FDA guidelines and GXPs in a fast-paced, science-driven environment.

The role involves cross-functional collaboration, training and mentoring, and contributing to continuous improvement initiatives while upholding internal standards and regulatory requirements.