Sr. Specialist, Quality Assurance (Pharmaceutical) Job
Job Description Job Attributes+
4343 W 62nd Street
Indianapolis, IN 46268, US
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.
AccountabilitiesMaintains accurate and current Quality recordsPerforms real-time QA review of batch documentation and other GMP related documents.Issuance and reconciliation of product labels for productionPerform AQL testing for visual inspectionUnderstands technical/release product issues and evaluate their potential impact on product quality and complianceChampion Quality, GMP compliance and EHS/Radiation Safety practicesAbility 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 requirementsDemonstrated 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 perspectivesPerforms other job duties as assigned
QualificationsA Covid-19 vaccination is required in order to be employed in this position. This includes either: 2 doses of the Moderna or Pfizer vaccine1 dose of the Johnson & Johnson vaccineBachelor's in science related field (processing engineering, Chemistry, Biology) or equivalent work experience preferred2+ years experience in related field preferred2 years of relevant work experience working with 21 CFR 210, 211 in the FDA regulated industry (Pharmaceutical or Medical Device) preferredPossess an understanding of cGMP/compliance requirements for cosmetic and pharmaceutical productsWorking knowledge of Microsoft Office Suite specifically Microsoft Word and Excel strongly preferredWorking knowledge of Adobe editing software strongly preferredWorking knowledge of Document Management software (Trackwise and/or Smartsolve) strongly preferredDemonstrated ability to manage timelines and prioritiesDemonstrated to work independently with minimum guidanceDemonstrated to multi-task and focus attention to detailWhile 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
What is expected of you and others at this levelApplies working knowledge in the application of concepts, principles, and technical capabilities to perform varied tasksWorks on projects of moderate scope and complexityIdentifies possible solutions to a variety of technical problems and takes actions to resolveApplies judgment within defined parametersReceives general guidance may receive more detailed instruction on new projectsWork reviewed for sound reasoning and accuracy
The primary work environment consists of a radiopharmaceutical manufacturing facility. Employees may handle radioactive materials and may be exposed to very low amounts of radiation that are deemed safe by current standards. 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 group. 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.
Your safety is our top priority. We regularly consult with medical professionals on best practices in COVID-19 prevention to protect our employees. We train our employees on these best practices and regularly clean our sites in accordance with CDC guidelines. Please note: All individuals entering our facilities are required to complete a self-health check, wear a mask and follow all posted guidelines
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.