CGMP Quality Assurance Specialist — Night Shift

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

Benefits offered by this job

Medical, dental and vision coverage

401k savings plan

Paid time off plan

Health savings account (HSA)

Flexible spending accounts (FSAs)

Disability coverage

Job summary

Cardinal Health is seeking a Quality Assurance Specialist to perform all quality review and release decisions at an FDA-regulated drug manufacturing facility in Columbus, OH. The role ensures CGMP-compliant processes for sterile injectables and supports documentation, audits, and CAPA closure.

The position requires 2–4 years of experience, a related bachelor’s degree, and proficiency with MS Excel/Word. Night shift experience and filing-system skills are preferred.

Qualifications

• 2-4 years of experience, preferred
• Bachelor's degree in related field, or equivalent work experience, preferred
• Proficiency with MS Excel and MS Word
• Interpersonal skills
• Attention to detail
• Prior experience working nightshift, preferred
• Prior experience maintaining a filing system, preferred
• Project management, preferred
• Prior experience in a cGMP environment, preferred

Responsibilities

• Handles CGMP documentation review related to product release, facilities and equipment, material controls, laboratory controls, packaging and labeling, and production & process controls.
• Establishes and reports metrics related products and processes as deemed necessary by the Regional Quality Manager RQM.
• Ensures the site manufactures products to meet the requirements of 21 CFR 212 (CGMP).
• Handles and ensures quality of documentation (control, retention, and archival) to support CGMP activities.
• Engages and collaborates with operations department to drive quality system and CGMP requirements.
• Performs product release activities per CGMP requirements.
• Monitors CAPA in investigations and closes when completed or escalates (if necessary).
• Performs aseptic review of the site with operations and documents results.
• Reports quality system issues to the RQM and others as necessary. This includes timely escalation of discrepancies upon identification

Skills

Interpersonal skills

Attention to detail

Night shift experience

Project management

cGMP knowledge

Education

Bachelor's degree or equivalent

Tools

MS Excel

MS Word

Job description

Cardinal Health is seeking a Quality Assurance Specialist to perform all quality review and release decisions at an FDA-regulated drug manufacturing facility in Columbus, OH. The role ensures CGMP-compliant processes for sterile injectables and supports documentation, audits, and CAPA closure.

The position requires 2–4 years of experience, a related bachelor’s degree, and proficiency with MS Excel/Word. Night shift experience and filing-system skills are preferred.