Senior Specialist, Quality Assurance Job
Job Description Job Attributes+
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Job ID
3b49a6b1-c705-431d-98ae-a9f40cc0dae7
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Req #
20144004
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Job Location
9866 Windisch Rd
West Chester, OH 45069, US -
Job Category
Quality
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Job Type
Regular
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Schedule
Full time
What Quality Assurance contributes to Cardinal Health
Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications.
Quality Assurance develops and implements a compliant and cost effective quality system that assures products and services are reliable, safe and effective. This job family provides oversight of production/manufacturing activities, training to operational and quality control personnel, and educates business leaders on Quality policies and procedures and ensures that all products and services are properly reviewed for quality and documented.
Job Summary
The quality assurance specialist (QAS) performs all quality review and approval/release decisions at an FDA-regulated drug manufacturing facility. The facility manufactures two sterile liquid injection drugs, FDG and NaF, that are used for Positron Emission Tomography (PET) scans.
Responsibilities
Handles 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 activities.Engages and collaborates with operations department to drive quality system and CGMP requirements.Performs product release activities per CGMP requirements.Monitors CAPA in investigations and closes when completed or escalates (if necessary).Performs aseptic review of the site with operations and documents results.Reports quality system issues to the RQM and others as necessary. This includes timely escalation of discrepancies upon identificationSchedule: 1am-9am Monday through Friday and 3am-7am every other Saturday and Sunday. Rotating schedule to accommodate weekend coverage is required.
Location: Onsite in West Chester, OH (Cincinnati)
Qualifications
2-4 years of experience, preferredBachelor's degree in related field, or equivalent work experience, preferredProficiency with MS Excel and MS WordInterpersonal skillsAttention to detailPrior experience working nightshift, preferredPrior experience maintaining a filing system, preferredProject management, preferredPrior experience in a cGMP environment, preferredWhat is expected of you and others at this level
Applies 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 action to resolveApplies judgment within defined parametersReceives general guidance and may receive more detailed instruction on new projectsWork reviewed for sound reasoning and accuracyAnticipated salary range: $66,500 - $95,000
Bonus eligible: No
Benefits: Cardinal Health offers a wide variety of benefits and programs to support health and well-being.
Medical, dental and vision coveragePaid time off planHealth savings account (HSA)401k savings planAccess to wages before pay day with myFlexPayFlexible spending accounts (FSAs)Short- and long-term disability coverageWork-Life resourcesPaid parental leaveHealthy lifestyle programsApplication window anticipated to close: 08/14/2024 *if interested in opportunity, please submit application as soon as possible.
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.
