Quality Assurance Engineer

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.

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

Responsibilities

• Support Manufacturing and perform Inspection
• 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

• Bachelors 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

Job Type: Full-time

Pay: $75,216.00 - $80,424.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Employee discount
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Parental leave
• Professional development assistance
• Tuition reimbursement
• Vision insurance

Experience level:

• 1 year
• 2 years

Schedule:

• Monday to Friday

Work Location: In person