Senior Quality Assurance Training Specialist

cardinalhealth; Indianapolis (IN); On-site; USD 69,000 - 88,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Paid time off plan

Health savings account (HSA)

401k savings plan

Access to wages before pay day with my

Job summary

Cardinal Health in Indianapolis is seeking a Senior Specialist, Quality Assurance focused on Training. You will execute quality programs and support the Supervisor in Training activities, providing actionable insights for addressing complex quality issues.

The role requires 2+ years in FDA-regulated environments, experience with 21 CFR parts 210/211, and strong technical writing skills. Anticipated salary range is provided with a comprehensive benefits package.

Qualifications

• Bachelor’s degree or equivalent in a related field.
• 2+ years of relevant work experience working with 21 CFR 210, 211 in the FDA regulated industry (Pharmaceutical or Medical Device).
• Experience in authoring documentation such as SOPs, Change Controls, CAPAs, Deviations and Laboratory Investigations.
• Understanding of cGMP and compliance requirements for pharmaceutical products.
• Proficient in Microsoft Word and Microsoft Excel and possess strong technical writing skills.

Responsibilities

• Assists in the oversite, development, and maintenance of employee training program, materials, and procedures.
• Helps ensure all aspects of employee training are compliant to quality standards and procedures.
• Facilitates and/or delivers in-person training, including new employee orientation and quality procedures/systems.
• Communicates with site personnel and management to meet training requirements.
• Assists in the administration and maintenance of the electronic Learning Management System (eLMS).
• Works with site management to identify training needs and develop training materials/curriculum.
• Evaluates training effectiveness.
• Keeps abreast of training and development research for new materials and techniques.
• Champions Quality, GMP compliance and EHS/Radiation Safety practices.
• Assist in GMP/GDP training and mentoring of GDP/GMP requirements.
• Partners with plant management to address quality deficiencies and implement corrective measures.
• Authors and optimizes SOPs and performs change controls, deviations, and CAPAs.

Skills

cGMP compliance knowledge

Technical writing

SOP development

Regulatory understanding

Education

Bachelor’s degree or equivalent in related field

Tools

Microsoft Word

Microsoft Excel

Job description

Cardinal Health in Indianapolis is seeking a Senior Specialist, Quality Assurance focused on Training. You will execute quality programs and support the Supervisor in Training activities, providing actionable insights for addressing complex quality issues.

The role requires 2+ years in FDA-regulated environments, experience with 21 CFR parts 210/211, and strong technical writing skills. Anticipated salary range is provided with a comprehensive benefits package.