Quality Assurance Specialist

Company: Cardinal Health
Location: East Hartford
Posted on: November 18, 2022

Job Description:

What Quality Assurance contributes to Cardinal HealthQuality Assurance is responsible for developing and implementing a compliant and cost-effective quality system that assures products and services are reliable, safe and effectiveDemonstrates 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.ResponsibilitiesHandles CGMP documentation review related to product release, facilities and equipment, material controls, laboratory controls, packaging and labeling, and production & process controls.Establishes and reports metrics related products and processes as deemed necessary by the Regional Quality Manager RQM.Ensures the site manufactures products to meet the requirements of 21 CFR 212 (CGMP)Handles and ensures quality of documentation (control, retention, and archival) to support CGMP activitiesEngages and collaborates with operations department to drive quality system and CGMP requirementsPerforms product release activities per CGMP requirementsReports quality system issues to the RQM and others as necessary. This includes timely escalation of discrepancies upon identification.QualificationsBachelor's degree in related science field, or equivalent work experience (Microbiology, Chemistry, Biology, Physics) preferred2+ years of experience in related science field preferred1-2 years of experience in Quality Assurance and/or regulated environment highly preferred - cGMP experience a plusPharmaceutical or medical device experience a plusISO experience a plusA Covid-19 vaccination or a legitimate accommodation is required in order to be employed in this position. Covid-19 vaccination includes:2 doses of the Moderna or Pfizer vaccine1 dose of the Johnson & Johnson vaccinePlease 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 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 accuracyAbility to manage several tasks at the same time; Ability to focus on tasks ; Ability to evaluate operating conditionsAbility to exercise sound judgment Personal Protective EquipmentSchedule: 40 hours per week. Overnight position. Typically Monday - Friday 1:00 am - 9:00 am. Additionally, one Sunday per month.Benefits eligible on Day 1 Medical, dental and vision plans.Paid time off plan offered401k savings planFlexible spending accounts (FSAs)Health savings account (HSA) Parental leaveEducation assistanceCardinal 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.To read and review this privacy notice click here

Keywords: Cardinal Health, East Hartford , Quality Assurance Specialist, Other , East Hartford, Connecticut