Senior Specialist, Quality Assurance

• Ensures fulfillment of external reporting requirements related to area of specialty, such as submitting necessary materials for product recalls. Submits reports for internal review prior to submission to regulatory bodies.
• Executes internal programs to define Quality guidelines and track adherence to these guidelines. Provides guidance to internal stakeholders regarding adherence to internal Quality Assurance policies and procedures as well as external requirements.
• Responds to significant quality issues and in support of the Manager, conducts root cause analyses, reports on relevant quality metrics and trends, and develops insights for internal stakeholders. Collaborates with Quality Assurance Specialists in other specialty areas as necessary to develop recommendations.
• Supports of the Change Control Program, by assessing Quality Assurance implications and impacts of operational and product changes, with a focus on specialty area.
• Updates standard operating procedures in response to product changes and regulatory developments under the general guidance of the Manager. Resolutions to significant quality issues, such as recalls or customer complaints, may set precedent for updates to SOPs.
• Prepares responses to regulatory queries, regulatory audits, and corporate audits and gathers necessary information from products and operations stakeholders.
• Supports the Manager, Quality Assurance in quality audits and inspections of distribution centers within the region. Records quality issues and provides draft reports and insights to the Manager, for delivery to the Operations stakeholders.
• Provides guidance to junior level Specialists on complex issues, assists with onboarding trainings, and frequently reviews the work of Specialists prior to delivery to a Manager.
• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
• While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to stand; walk; use hands to finger, handle or feel; and reach with hands and arms; balance; stoop, kneel, crouch or crawl. The employee must occasionally lift or move up to 25 pounds. Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, depth perception and the ability to adjust focus.
• The primary work environment consists of a professional office environment within a radiopharmaceutical manufacturing facility, the materials warehouse as well as the laboratory setting.
• The facility is operated under well-controlled and closely monitored conditions that are regulated by both State and Federal agencies, and that are enforced by the corporate internal quality and regulatory groups. Each staff member will receive specific training in keeping radiation exposures within regulatory guidelines and he/she will be routinely monitored for their exposure to radiation. Noise levels are considered low to moderate.

• 2-4 years of experience, preferred
• Bachelor's degree in related field, or equivalent work experience, preferred

• 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

• This is a night position. Typically, Monday – Friday between either 1:00 am -11:00 am or 4:00 am- 1:00 pm and every other Saturday.
• Candidate must be flexible to work different shifts or schedules based on business need. Candidate must be comfortable staying until work is completed each business day. Work hours may be subject to change.

• 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
• Work-Life resources
• Paid parental leave
• Healthy lifestyle programs

Cardinal Health