Sr. Specialist - Training, Quality Assurance

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.

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.

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.

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