Senior QA Training & Compliance Specialist

Cardinal Health, Inc.; Legendary Hills (IN); On-site; USD 69,000 - 88,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Paid time off

Health savings account (HSA)

401k savings plan

Access to wages with myFlexPay

Flexible spending accounts (FSAs)

Disability coverage

Work-Life resources

Paid parental leave

Healthy lifestyle programs

Job summary

Cardinal Health, Inc. seeks a Senior Specialist, Quality Assurance (Training) to execute quality programs and drive regulatory compliance within a training specialty.

This role supports the Supervisor, Quality Assurance in Training and develops actionable insights for addressing complex quality issues. You will help develop and maintain the employee training program, deliver training, manage the eLMS, and collaborate with plant management to identify training needs and deliver GMP/GDP training

Qualifications

• Bachelor’s degree or equivalent in a related field.
• Minimum 2 years of FDA-regulated experience (21 CFR 210, 211).
• Experience in authoring SOPs, Change Controls, CAPAs, Deviations and Laboratory Investigations.
• Understanding of cGMP and pharmaceutical compliance requirements.
• Proficient in Microsoft Word and Excel with strong technical writing skills.

Responsibilities

• Assist in the oversight, development, and maintenance of the employee training program, materials, and procedures.
• Ensure training aligns with quality standards and procedures.
• Deliver in-person training, including new employee orientation and quality procedures/systems.
• Communicate professionally with site personnel to meet training requirements.
• Administer and maintain the eLMS, including creation of training items, curriculums, and user groups.
• Identify training needs and develop training materials/curricula.
• Evaluate training effectiveness.
• Stay updated on training and development research.
• Champion GMP compliance and EHS/Radiation Safety practices.
• Assist in GMP/GDP training and mentor GDP/GMP requirements.
• Collaborate with management to address quality deficiencies and implement corrective actions.
• Authorize and optimize SOPs; perform change controls, deviations, and CAPAs as needed.
• Assist in change control and non-conformance processes and review quality events.
• Network across units to achieve positive outcomes.
• Challenge GMP activities, including metrics and annual reporting, with knowledge of production processes.
• Perform special projects as needed.

Skills

Bachelor's degree

FDA (21 CFR 210, 211)

Documentation (SOPs, CAPAs, Deviations

cGMP compliance

Technical writing (Word/Excel)

Education

Bachelor's degree

Job description

Cardinal Health, Inc. seeks a Senior Specialist, Quality Assurance (Training) to execute quality programs and drive regulatory compliance within a training specialty.

This role supports the Supervisor, Quality Assurance in Training and develops actionable insights for addressing complex quality issues. You will help develop and maintain the employee training program, deliver training, manage the eLMS, and collaborate with plant management to identify training needs and deliver GMP/GDP training