Sr. Specialist, Quality Assurance

What Quality Assurance contributes to Cardinal Health

Quality Assurance is responsible for developing and implementing a compliant and cost effective quality system that assures products and services are reliable, safe and effective.

• Demonstrates knowledge of quality systems and approaches.
• Demonstrates an understanding of the relevant regulations, standards and operating procedures.
• Demonstrates ability to perform investigations / root cause analysis and develop corrective actions.
• Demonstrates an understanding of the requirements and has the ability to perform gap assessments to those requirements.
• Demonstrates an understanding of quality concepts such as: cost of quality, analytical metrics and / or statistics, trending, quality planning, validation, CAPA and problem solving.
• Works cross-functionally and has the ability to interpret the requirements as well as educate and influence others on those requirements.

Responsibilities

• Maintains accurate and current Quality records
• Performs real-time QA review of batch documentation and other GMP related documents.
• Issuance and reconciliation of product labels for production
• Perform AQL testing for visual inspection
• Understands technical/release product issues and evaluate their potential impact on product quality and compliance
• Champion Quality, GMP compliance and EHS/Radiation Safety practices
• Ability to network across business and functional units to achieve positive outcomes.
• Assists Quality Management with FDA and other regulatory agency activities.
• Demonstrates efforts to discovering, meeting and advocating for the customer’s needs.
• Takes actions to continually improve quality and safety in daily work. Actively participates in improving work processes to meet and exceed expectations. Identifies opportunities for improvement based on process observations, outcome measures, and feedback.
• Reports errors in a timely and appropriate manner. Takes initiative and is accountable for areas of responsibility meeting regulatory requirements including but not limited to maintaining required trainings as appropriate to position requirements
• Demonstrated ability to act calmly and patiently when working under pressure and/conditions of stress. Maintains integrity, composure, communicates with honesty, transparency, clarity and promotes alternative perspectives
• Performs other job duties as assigned

Qualifications

• Bachelor's in science related field (processing engineering, Chemistry, Biology) or equivalent work experience preferred
• 2+ years’ experience in related field preferred
• 2 years of relevant work experience working with 21 CFR 210, 211 in the FDA regulated industry (Pharmaceutical or Medical Device) preferred
• Possess an understanding of cGMP/compliance requirements for cosmetic and pharmaceutical products
• Working knowledge of Microsoft Office Suite specifically Microsoft Word and Excel strongly preferred
• Working knowledge of Adobe editing software strongly preferred
• Working knowledge of Document Management software (Trackwise and/or Smartsolve) strongly preferred
• Demonstrated ability to manage timelines and priorities
• Demonstrated to work independently with minimum guidance
• Demonstrated to multi-task and focus attention to detail
• 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

A Covid-19 vaccination is required in order to be employed in this position. This includes either: 

• 2 doses of the Moderna or Pfizer vaccine
• 1 dose of the Johnson & Johnson vaccine
• Please Note: vaccines may be required for the position subject to federal, state and/or customer requirements

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 actions to resolve
• Applies judgment within defined parameters
• Receives general guidance may receive more detailed instruction on new projects
• Work reviewed for sound reasoning and accuracy

Work Environment 

• The primary work environment consists of a radiopharmaceutical manufacturing facility. 
• Employ