- 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.
- 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.
- 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%.
- 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.
-
Omega Dynamics Johnson City, United StatesCreate something fascinating: Your tasks · Assembly or functional testing of complex complete devices · Dismantling of simple devices within a defined product range · Preparation of components and spare parts according to inspection lists at the workplace · Quality assurance thro ...
-
Janitorial Supervisor
2 weeks ago
Allied Universal Coralville, United States Full timeOverview · Allied Universal Janitorial Services is uniquely capable and personally committed to delivering exceptional janitorial services. We offer medical, dental and vision coverage, life insurance, retirement plan, employee assistance programs, company discounts, perks and m ...
-
Regional Director of Sales
3 days ago
Kinseth Hospitality Coralville, United States Full timeThis position will be based out of the Omaha/Council Bluffs area. Applicants must be a resident of that area or willing to relocate. · SUMMARY · Assists in overseeing property Director of Sales and/or General Manager/AGM to increase revenues at area properties and assist in train ...
-
Beverage Production Manager
2 weeks ago
Wilson's Orchard Iowa City, United StatesAs Beverage Production Manager you will be responsible for producing outstanding beverages for the Wilson's Orchard and Sutliff brands. You will directly oversee our fast growing beverage production team and you will be responsible for all operational tasks involved in producing, ...
-
Supervisor, Central Sterilizing
2 weeks ago
University of Iowa Iowa City, United StatesThis position provides a specialized level of technical service relative to the processing of instruments for the Main OR and UIHC clinics. This includes responsibility for staff education, equipment maintenance, and supplies.The supervisor collaborates with clinical and non-clin ...
-
Quality Manager
1 week ago
A. O. Smith Corporation Johnson City, United StatesCompany / Location Information · A. O. Smith is a global leader applying innovative technologies and energy-efficient solutions to products manufactured and marketed worldwide. The company is one of the world's leading manufacturers of residential and commercial water heating equ ...
-
Dean of the College of Nursing
2 weeks ago
InsideHigherEd Johnson City, United States Executive Administration Jobs ,Dean of the College of Nursing · East Tennessee State University · East Tennessee State University (ETSU) invites applications and nominations for an experienced, creative, student-focused, and dynamic leader to serve as Dean of the College of Nursing. We seek a visionary who wil ...
-
Clin Trials Rsrch Asst/Data Mg
6 days ago
University of Iowa Iowa City, United States Full timeBASIC FUNCTION · Support, conduct and manage clinical trials to deliver and evaluate research protocols and clinical trials in the Gastroenterology and Hepatology Division of Internal Medicine. Key areas of responsibility include protocol development/management and study respons ...
-
Research Assistant-Department of Otolaryngology
2 weeks ago
University of Iowa Iowa City, United StatesThe Department of Otolaryngology at the University of Hospitals and Clinics is seeking a Research Assistant under the supervision of Dr. Alex Claussen. Alexander Claussen, MD is an Otolaryngologist specializing in Otology and Neurotology. His clinical practice and research focus ...
-
Office Manager Job
6 days ago
FYZICAL Therapy & Balance Centers Johnson City, United StatesOffice Manager Job – Johnson City, NY 49040 · Why You'll Love This Job · FYZICAL Therapy and Balance Centers, the country's leading health and wellness provider, is looking for a natural-born leader with a passion for making a lasting impact on the healthcare industry to join ...
-
CAT Repair Solution Site Manager
3 days ago
Sedgwick Iowa City, United States Full timeTaking care of people is at the heart of everything we do, and we start by taking care of you, our valued colleague. A career at Sedgwick means experiencing our culture of caring. It means having flexibility and time for all the things that are important to you. It's an opportuni ...
-
Licensed Practical Nurse
2 weeks ago
University of Iowa Iowa City, United StatesUniversity of Iowa Hospitals & Clinics—recognized as one of the best hospitals in the United States—is Iowa's only comprehensive academic medical center and a regional referral center. Each day more than 12,000 employees, students, and volunteers work together to provide safe, qu ...
-
Nursing Practice Leader
2 weeks ago
University of Iowa Iowa City, United States Full timeUniversity of Iowa Hospitals & Clinics-recognized as one of the best hospitals in the United States-is Iowa's only comprehensive academic medical center and a regional referral center. Each day more than 12,000 employees, students, and volunteers work together to provide safe, qu ...
-
Physician Assistant
1 week ago
University of Iowa Iowa City, United StatesBASIC FUNCTION · Provide patient care for the adult outpatient Hematology service, a multi-specialty service, under the direction of the attending physician(s). Provide overall medical care and management for patients, exercising autonomy in the services provided. Plan, deliver ...
-
Licensed Practical Nurse
4 weeks ago
University of Iowa Iowa City, United StatesUniversity of Iowa Hospitals & Clinics—recognized as one of the best hospitals in the United States—is Iowa's only comprehensive academic medical center and a regional referral center. Each day more than 12,000 employees, students, and volunteers work together to provide safe, qu ...
-
50% ARNP
6 days ago
University of Iowa Iowa City, United StatesBASIC FUNCTION AND RESPONSIBILITY · Will perform pre-operative/pre-anesthesia assessment for patients scheduled for surgery in UIHC; the ARNP will exercise autonomy in medical decision-making and services provided. · CHARACTERISTIC DUTIES AND RESPONSIBILITIES · • Perform preope ...
-
50% ARNP
2 weeks ago
University of Iowa Iowa City, United States Full timeBASIC FUNCTION AND RESPONSIBILITY · Will perform pre-operative/pre-anesthesia assessment for patients scheduled for surgery in UIHC; the ARNP will exercise autonomy in medical decision-making and services provided. · CHARACTERISTIC DUTIES AND RESPONSIBILITIES · • Perform preopera ...
-
Physician Assistant
1 week ago
University of Iowa Iowa City, United States Full timeBASIC FUNCTION · Provide patient care for the adult outpatient Hematology service, a multi-specialty service, under the direction of the attending physician(s). Provide overall medical care and management for patients, exercising autonomy in the services provided. Plan, deliver, ...
-
Admin Services Specialist-Radiology
2 weeks ago
University of Iowa Iowa City, United States Full timeThe University of Iowa Hospitals and Clinics department of Radiology is seeking an Administrative Services Specialist to oversee the administrative operations. This position will work under the direction of the Clinical Department Administrator and Department Chair. Ensures the d ...
-
Clinic Supervisor
2 weeks ago
University of Iowa Iowa City, United States Full timeThe University of Iowa Community Clinics (UICC), Downtown Clinics is seeking a Clinic Supervisor to support our Urology Clinic in Iowa City. In this pivotal role, you'll play a vital part in the day-to-day management of medical clinics and staff. Your responsibilities will span s ...
Radiopharmaceutical Quality Assurance Manager - Coralville, United States - Perspective Therapeutics
Description
Job Description
Job DescriptionObjectiveThe 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
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
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.
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:
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.
Powered by JazzHR
fT18koI9zk