Quality Line Inspector

Cardinal Health•Indianapolis, IN

3d•$67,500 - $96,400•Onsite

About The Position

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. Hours: Weekend Shift Friday and Monday - 7AM to 4PM Saturday and Sunday - 7AM to 7 PM

Requirements

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 preferred
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 preferred
Demonstrated to work independently with minimum guidance preferred
Demonstrated to multi-task and focus attention to detail 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 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

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

Benefits

Cardinal Health offers a wide variety of benefits and programs to support health and well-being.
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