CGMP QA Specialist — Night Shift Drug Manufacturing

Cardinal Health; Kentucky; On-site; USD 67,000 - 95,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

PTO

HSA

401k

Wages on demand

FSAs

Disability insurance

Parental leave

Job summary

Cardinal Health is seeking a Quality Assurance Specialist (QAS) for an FDA-regulated drug manufacturing facility in Columbus, OH. The role focuses on CGMP documentation, product release, and quality system management to ensure compliance with 21 CFR 212.

The role requires 2–4 years of experience, proficiency in MS Excel and MS Word, and strong attention to detail. Night shifts and filing/system management experience are preferred, with opportunities for process improvement and collaboration with

Qualifications

• 2-4 years of experience
• Bachelor's degree in related field, or equivalent work experience
• Proficiency with MS Excel and MS Word
• Interpersonal skills
• Attention to detail
• Preferred: night shift
• Preferred: filing system
• Preferred: project management
• Preferred: prior experience in a cGMP environment

Responsibilities

• Reviews CGMP documentation related to product release, facilities and equipment, material controls, laboratory controls, packaging and labeling, and production & process controls.
• Establishes and reports metrics related to products and processes as required by the Regional Quality Manager (RQM).
• Ensures the site manufactures products to meet 21 CFR 212 CGMP requirements.
• Handles and ensures quality of documentation (control, retention, archival) to support CGMP activities.
• Collaborates with operations to drive quality systems and CGMP requirements.
• Performs product release activities per CGMP requirements.
• Monitors CAPA in investigations and closes or escalates as needed.
• Performs aseptic review of the site with operations and documents results.
• Reports quality system issues to the RQM and others as necessary.
• Escalates discrepancies in a timely manner.

Skills

Interpersonal skills

Attention to detail

Education

Bachelor's degree or equivalent

Tools

MS Excel

MS Word

Job description

Cardinal Health is seeking a Quality Assurance Specialist (QAS) for an FDA-regulated drug manufacturing facility in Columbus, OH. The role focuses on CGMP documentation, product release, and quality system management to ensure compliance with 21 CFR 212.

The role requires 2–4 years of experience, proficiency in MS Excel and MS Word, and strong attention to detail. Night shifts and filing/system management experience are preferred, with opportunities for process improvement and collaboration with