Sr. Specialist, Quality Assurance

Cardinal Health has partnered with a Global leader in Specialty Medicine, to launch a new drug into the US market.  Come be a part of an amazing team.

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.
• Works cross-functionally and has the ability to interpret the requirements as well as educate and influence others on those 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 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

Responsibilities:

• Handles CGMP documentation review related to product release, facilities and equipment, material controls, laboratory controls, packaging and labeling, and production & process controls.
• Handles CGMP documentation review related to product release, facilities and equipment, material controls, laboratory controls, packaging and labeling, and production & process controls.
• Engage and collaboration with operations department to drive quality system and cGMP requirements.
• Support the production and laboratory operations by being a QA presence on the shop floor; conduct real-time documentation reviews, ensure compliance to site procedures and regulations, and provide guidance where appropriate.
• Assist Quality Management with Regulatory Body Inspections.
• Performs other duties as assigned

Qualifications:

• Bachelor of Science degree preferred or equivalent work experience
• 3-5 years of relevant work experience in GMP and/or FDA regulated industry (Pharmaceutical or Medical Device) preferred
• Must work well with others and understand how to be successful in a Team environment. 
• Must be detail oriented, organized, able to multi-task, a self-starter, and self-motivated
• ISO experience a plus
• Quality Assurance background preferred

Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.

Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.