Quality Assurance Manager - Healthcare jobs in Iowa
Quality Assurance Manager - Healthcare manages and implements the quality management and quality improvement programs for a healthcare facility. Oversees quality assurance and compliance functions. Being a Quality Assurance Manager - Healthcare ensures programs and services are implemented at the highest standards and patients receive the highest level of care. Responsible for monitoring and updating policies and procedures to include regulatory changes. Additionally, Quality Assurance Manager - Healthcare requires a bachelor's degree. Requires a certification of registered nurse. Typically reports to a head of a unit/department. The Quality Assurance Manager - Healthcare typically manages through subordinate managers and professionals in larger groups of moderate complexity. Provides input to strategic decisions that affect the functional area of responsibility. May give input into developing the budget. To be a Quality Assurance Manager - Healthcare typically requires 3+ years of managerial experience. Capable of resolving escalated issues arising from operations and requiring coordination with other departments. (Copyright 2024 Salary.com)
Recently Added Quality Assurance Manager - Healthcare jobs
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 / AbilityFor information on Perspective Therapeutics, visit our website at: www.perspectivetherapeutics.com.
- 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%.
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.
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
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...
- 21 Days Ago
Quality Assurance Manager
- Procter & Gamble
-
Iowa, IA
FULL_TIME
- Job Location Cincinnati Job Description Job Description P&G is the largest consumer packaged goods company in the world. We have operations in over 75 countries, with 65 trusted brands that improve li...
- Just Posted
Assistant Quality Assurance Manager
- BoDeans Baking Group
-
Le Mars, IA
FULL_TIME
- JOB SUMMARYThe Assistant Quality Assurance Manager will support the Le Mars Cone and Wafer/Cookie Facilities by facilitating and maintaining the food safety and quality programs under the direction of...
- 13 Days Ago
Quality Assurance Manager
- iLocatum
-
Fort Madison, IA
FULL_TIME
- Ensures food safety and quality of all products produced in the plant. Responsible for ensuring specifications are defined and communicated. Performs inspections of processes, employee training, compl...
- 13 Days Ago
Quality Assurance Operations Manager
- ByHeart, Inc
-
Allerton, IA
FULL_TIME
- ByHeart is an infant nutrition company built from the ground up to deliver real innovation on behalf of babies and parents. Our mission is simple: make the best formula in the world. That’s why we stu...
- 1 Month Ago
Quality Assurance Manager - Healthcare jobs at Popular Companies
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- Memorial Hermann Health System
-
Houston, TX
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-
Houston, TX
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- Memorial Hermann Health System
-
Houston, TX
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Director of Quality Management- Healthcare
- Sobriety Centers of New Hampshire
-
Laconia, NH
- Position will require frequent travel between Antrim, NH and Laconia, NH The Director of Quality Management is responsib...
- 4/24/2024 12:00:00 AM
Director of Quality Management / Registered Nurse
- HealthCare Support
-
San Leandro, CA
- Director of Quality Management HealthCare Support is actively seeking a Director of Quality Management to fill an openin...
- 4/24/2024 12:00:00 AM
Material Handler I (Depot, 2nd Shift)
- Epson America, Inc.
-
Indianapolis, IN
- ** Material Handler I (Depot, 2nd Shift)** Location: Indianapolis, IN, US Requisition ID: 5169 Company: Epson America, I...
- 4/24/2024 12:00:00 AM
Director of Quality Management- Healthcare
- Sobriety Centers of New Hampshire
-
Laconia, NH
- Position will require frequent travel between Antrim, NH and Laconia, NH The Director of Quality Management is responsib...
- 4/22/2024 12:00:00 AM
About Iowa
Iowa (/ˈaɪəwə/ (listen)) is a state in the Midwestern United States, bordered by the Mississippi River to the east and the Missouri River and Big Sioux River to the west. It is bordered by six states; Wisconsin to the northeast, Illinois to the east, Missouri to the south, Nebraska to the west, South Dakota to the northwest and Minnesota to the north.
In colonial times, Iowa was a part of French Louisiana and Spanish Louisiana; its state flag is patterned after the flag of France. After the Louisiana Purchase, people laid the foundation for an agriculture-based economy in the heart of the Corn...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Quality Assurance Manager - Healthcare jobs
$97,321 to $123,722
Most Popular Cities in Iowa for Quality Assurance Manager - Healthcare Jobs
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