IT Quality Assurance Manager jobs in Iowa City, IA

IT Quality Assurance Manager manages a group of quality assurance analysts who evaluate, test, and validate software and/or IT services. Develops and implements quality assurance problem reporting processes and systems. Being an IT Quality Assurance Manager analyzes deficiencies in service or performance and recommends product or service improvements to address problems. Designs and implements defect reduction programs. Additionally, IT Quality Assurance Manager requires a bachelor's degree. Typically reports to head of a unit/department. The IT Quality Assurance Manager manages subordinate staff in the day-to-day performance of their jobs. True first level manager. Ensures that project/department milestones/goals are met and adhering to approved budgets. Has full authority for personnel actions. To be an IT Quality Assurance Manager typically requires 5 years experience in the related area as an individual contributor. 1 - 3 years supervisory experience may be required. Extensive knowledge of the function and department processes. (Copyright 2024 Salary.com)

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Radiopharmaceutical Quality Assurance Manager
  • Perspective Therapeutics
  • Coralville, IA FULL_TIME
  • Objective

    The Manager, Quality Assurance helps ensure the consistent production of safe, effective, and high-quality radiopharmaceutical products that meet regulatory requirements and industry standards at the site level.  This involves overseeing all aspects of quality assurance throughout the manufacturing process in alignment with company objectives, including testing, documentation, and compliance with Good Manufacturing Practices (GMP) and other relevant regulations.  Additionally, the Manager is responsible for implementing quality improvement initiatives, training staff, and facilitating communication between different departments to maintain and enhance the overall quality management system.

    Essential Functions
     
    • Directs the day-to-day activities of the Quality Assurance team at the designated facility.
    • Communicates aligned quality objectives and requirements to company management and co-workers with a goal to foster a company-wide culture of quality focus and compliance.
    • Manages and executes a quality management program consistent with pharmaceutical manufacturer requirements for API starting material and finished drug products.
    • Executes and enhances quality aspects of project-specific plans to support company goals.
    • Participates in company initiatives to apply quality principles to procedures and standards.
    • Reviews design specifications, procedures, and other technical documents to ensure GXP alignment with GXP requirements.
    • Oversees Change Control for TPI processes subject to quality requirements.
    • Develops personnel training related to quality and good manufacturing practices.
    • Oversees implementation and training of the Quality Management System (QMS).
    • Oversees batch record approval process and acts as responsible manager ensuring quality attributes of batch.
    • Manages the audit program, including regular internal audits and a supplier audit program.  Directs the resolution of findings and ensures proper follow-up.
    • Signatory to Quality Agreements associated with Supply Agreements.
    • Manages Corrective and Preventive Action (CAPA) program, Continuous Improvement initiatives, Risk Management, and Out-of-Specification Investigations.
    Qualifications
     
    To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

    Education / Experience
     
    • Bachelor's Degree in a science, health, or related field (extensive equivalent QA experience in a pharmaceutical discipline may be considered as a substitute for academic degree).
    • At least 7 years of progressive experience in GxP, QA management or QA positions in a Pharmaceutical and/or Medical Device industry is required.
    • Experience with manufacture of sterile products, with aseptic expertise preferred.
    • In-depth knowledge of radiopharmaceutical manufacturing processes is preferred, with a proven track record of implementing and maintaining robust quality management systems.
    • Experience in compliance with Current Good Manufacturing Practices for pharmaceuticals and FDA Part 210/211 is required, and experience with Good Clinical Practices preferred.
    • Must have experience with CAPA, Root Cause Analysis, Continuous Improvement, and OOS investigations.
    Knowledge / Skill / Ability
     
    • Understand the principles of radiation safety and apply worker safety considerations to procedures, with the guidance of Perspective radiation safety experts.
    • Understanding of sterile drug manufacturing requirements.
    • Must have keen attention to detail with the ability to read and interpret regulatory requirements and industry standards and apply information to quality standards.
    • Excellent written, verbal and interpersonal communication skills, with proven ability to collaborate, communicate and manage well at all levels of the organization.
    • Demonstrated ability to work independently, manage projects and lead change across the organization.
    • Ability to focus on critical issues and balance and respond to competing short-term and long-term priorities.
    • commitment to continuous improvement to drive excellence in aseptic, radiopharmaceutical quality assurance practices.
    • Commitment to continuous improvement to drive excellence in aseptic radiopharmaceutical quality assurance practices.
    • Ability to facilitate meetings and discussions in person and virtually.
    • Ability to travel up to 30%.
    Work Environment

    The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
     
    • Must be willing to work in a facility producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels.
    • Must be able to work outside of regular work hours, including off shift, weekend, and holiday work as business needs require.
    • May be required to sit or stand for long periods of 8 hours a day while performing duties. 
    • Occasional kneeling, crouching, twisting the upper body, bending, stooping, pushing, pulling, or reaching may be required.
    • Must possess good hand-eye coordination; close attention to detail is required.
    • Must be able to work indoors and outdoors with exposure to mechanical/moving parts, hazards including radioactive, corrosive, flammable and toxic material, dust, dirt, odors, and irritants.
    • Must be willing to wear a variety of Personal Protective Equipment (PPE), including eye and hearing protection, as needed.
    • Willingness to complete safety training within allotted timeframes, and work in a team-based environment.

    Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
     
    For information on Perspective Therapeutics, visit our website at: www.perspectivetherapeutics.com.

    Perspective Therapeutics provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

    This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
     
  • 18 Days Ago

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MANAGER, QUALITY ASSURANCE
  • Crown Holdings
  • Dubuque, IA FULL_TIME
  • Job Accountabilities CROWN Cork & Seal USA, Inc., a wholly owned company of Crown Holdings, Inc. is a global leader in the design, manufacture and sale of packaging products for consumer goods. At Cro...
  • 20 Days Ago

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Quality Assurance Manager
  • Impact Solutions Inc
  • Decorah, IA FULL_TIME
  • Job Title: Quality Assurance Manager Location: Decorah, Iowa Salary: $80-100K Job Summary of the Quality Assurance Manager: The Quality Assurance Manager is a member of the Processing Management Team,...
  • 1 Month Ago

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Quality Assurance Specialist I
  • Perspective Therapeutics
  • Coralville, IA FULL_TIME
  • ObjectiveThe Quality Assurance Specialist I will support the design, implementation and maintenance of QA and compliance programs including, but not limited to an SOP system and corrective action and ...
  • 16 Days Ago

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Quality Assurance Inspector
  • Berry Global, Inc
  • PEOSTA, IA FULL_TIME
  • Overview About BerryHarnessing the strength in our diversity and industry-leading talent of 40,000 employees across more than 250 global locations, we develop, design, and manufacture innovative produ...
  • Just Posted

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Quality Assurance Specialist
  • DW PRODUCTS
  • Rapids, IA FULL_TIME
  • Quality Assurance (Grow in this role!)We are currently seeking reliable and intelligent candidates for our Quality Assurance Team, someone to learn and reinforce our processes and to eventually take c...
  • 14 Days Ago

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0 IT Quality Assurance Manager jobs found in Iowa City, IA area

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Document Admin - Control Records Management Position!
  • Beacon Hill
  • Cedar Rapids, IA
  • Document Administration - Document Control Records Management Local to Cedar Rapids, IA Contract - 12+ months This posit...
  • 4/24/2024 12:00:00 AM

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Underwriting Business Process Analyst II
  • United Fire & Casualty Company
  • Cedar Rapids, IA
  • UFG is looking for anUnderwriting Business Process Analyst II to join the team who will support Commercial Underwriting ...
  • 4/24/2024 12:00:00 AM

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Telecom Field Engineer
  • Beacon Hill
  • Cedar Rapids, IA
  • Field Service Engineer II JOB SUMMARY: Performs non-routine to moderately complex engineering detail and field work, ens...
  • 4/23/2024 12:00:00 AM

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Program Integrity & Compliance Quality Assurance Manager
  • Public Consulting Group
  • Cedar Rapids, IA
  • OverviewPublic Consulting Group LLC (PCG) is a leading public sector solutions implementation and operations improvement...
  • 4/22/2024 12:00:00 AM

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UICC HR Recruitment Specialist 100%
  • The University Of Iowa
  • Iowa City, IA
  • The University of Iowa CommunityClinics (UICC)is seeking a Human Resources Recruitment Specialist to support ourgrowing ...
  • 4/22/2024 12:00:00 AM

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Service Coordinator
  • Reach For Your Potential
  • Iowa City, IA
  • Job Description Job Description POSITION SUMMARY: The Service Coordinator is the contact point for all services provided...
  • 4/22/2024 12:00:00 AM

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Automation Software Engineer
  • Integration International Inc.
  • Cedar Rapids, IA
  • Job Role: At least 3 years' experience in the specific role but may have some general working experience - focus on deve...
  • 4/21/2024 12:00:00 AM

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Telecom Field Engineer
  • Beacon Hill Staffing Group
  • Cedar Rapids, IA
  • Field Service Engineer II JOB SUMMARY: Performs non-routine to moderately complex engineering detail and field work, ens...
  • 4/20/2024 12:00:00 AM

Iowa City is a city in Johnson County, Iowa, United States. It is the home of the University of Iowa and county seat of Johnson County, at the center of the Iowa City Metropolitan Statistical Area. The U.S. Census Bureau estimated the city's population at 75,798 in 2017, making it the state's fifth-largest city. Iowa City is the county seat of Johnson County. The metropolitan area, which encompasses Johnson and Washington counties, has a population of over 171,000. Iowa City was the second capital of the Iowa Territory and the first capital city of the State of Iowa. The Old Capitol building i...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for IT Quality Assurance Manager jobs
$118,075 to $156,321
Iowa City, Iowa area prices
were up 0.8% from a year ago

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