Sr. Specialist - Training, Quality Assurance

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

What Quality Assurance contributes to Cardinal Health

Quality Assurance is responsible for the cGMP documentation review related to product release, material controls, laboratory controls, packaging and labeling, and production and process controls.

• Demonstrates knowledge of quality systems and approaches and an understanding of the relevant regulation, standards, and operating procedures.
• Assists in ensuring all aspects of employee training are kept up to date and compliant to all regulatory and quality requirements.
• Helps oversee the employee training program, including applicable materials, procedures, and in-person/virtual training.
• Assists in the responsibility of ensuring all quality standards and procedures are followed and projects manufactured are of the highest quality possible.
• Authorized to inspect products to ensure quality standards are met.
• Adheres to established policies and procedures.
• Provides technical guidance and training to others on SOPs and quality guidelines.

Job Summary

The Senior Specialist, Quality Assurance executes quality programs, policies, and procedures in a particular area of specialty (Training) in order to minimize risks, drive compliance, and adhere to regulatory requirements. Applying knowledge of quality assurance concepts and technical capabilities, the Senior Specialist supports the Supervisor, Quality Assurance in Training activities and develops actionable insights and recommendations for addressing complex quality issues.

Responsibilities

• Assists in the oversite, development, and maintenance of employee training program, materials, and procedures.
• Helps ensure all aspects of employee training are complaint to quality standards and procedures.
• Facilitates and/or delivers in-person training, including but not limited to, new employee orientation and quality procedures/systems.
• Effectively communicates and interacts with site personnel and management in a professional, collaborative, and respectful manner to ensure that their technical and compliance-based training requirements are met.
• Assists in the administration and maintenance of the electronic Learning Management System (eLMS) including the creation of new training items, curriculums, and user groups.
• Works with site management to identify training needs and in the development of training materials/curriculum.
• Evaluates training effectiveness.
• Keeps abreast of training and development research for new materials, methods, and techniques.
• Champion Quality, GMP compliance and EHS/Radiation Safety practices.
• Assist in the development and facilitation of GMP/GDP training of all employees. Follows/ mentors GDP/GMP requirements.
• Actively partner with plant management and personnel in troubleshooting quality deficiencies and implement corrective measures to eliminate quality problems, including but not limited to, employee training.
• Authors and optimizes SOPs and other documents as necessary and performs change controls, deviations, and CAPAs as needed.
• May assist in various Quality Assurance duties such as: change control and non-conformance processes and review/approval of quality events.
• Ability to network across business and functional units to achieve positive outcomes.
• Able to challenge, appropriately, the design, conduct, and reporting of GMP activities including metrics and annual reporting. In that context, has the knowledge of the production process of the product.
• Performs special projects or tasks as necessary based on skill set and/or development goals and business needs.

Qualifications

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

What is expected of you and others at this level

• Applies working knowledge in the application of concepts, principles and technical capabilities to perform varied tasks
• Works on projects of moderate scope and complexity
• Identifies possible solutions to a variety of technical problems and takes action to resolve
• Applies judgment within defined parameters
• Receives general guidance and may receive more detailed instruction on new projects
• Work reviewed for sound reasoning and accuracy

Anticipated salary range:$68,500.00-$88,020.00

Bonus eligible:No

Benefits

Cardinal Health offers a wide variety of benefits and programs to support health and well-being.

• Medical, dental and vision coverage
• Paid time off plan
• Health savings account (HSA)
• 401k savings plan
• Access to wages before pay day with myFlexPay
• Flexible spending accounts (FSAs)
• Short- and long-term disability coverage