Senior PET Radiochemist – Quality Specialist Level 1 in Rochester

Full-time @Mayo Clinic in Radiology
  • Rochester, Minnesota View on Map
  • Apply Before : January 7, 2023

Job Description

Looking to join family of clinics, hospitals and other health care facilities in Rochester? Mayo Clinic is hiring Full-Time Senior PET Radiochemist – Quality Specialist Level 1 in Rochester Minnesota to provide an unparalleled experience as the most trusted partner for health care.

 

Job Title : Senior PET Radiochemist – Quality Specialist Level 1

Location : Rochester, Minnesota

Job Type : Full-Time

Category: Radiology

Job ID: 192924BR

 

Job Details :

Why Mayo Clinic
Mayo Clinic is the nation’s best hospital (U.S. News & World Report, 2022-2023) and ranked #1 in more specialties than any other care provider. We have a vast array of opportunities ranging from Nursing, Clinical, to Finance, IT, Administrative, Research and Support Services to name a few. Across all locations, you’ll find career opportunities that support diversity, equity and inclusion. At Mayo Clinic, we invest in you with opportunities for growth and development and our benefits and compensation package are highly competitive. We invite you to be a part of our team where you’ll discover a culture of teamwork, professionalism, mutual respect, and most importantly, a life-changing career!

Mayo Clinic offers a variety of employee benefits. For additional information please visit Mayo Clinic Benefits. Eligibility may vary.

Position description
Primarily responsible for design, implementation, and management of a Quality System according to the directives of Nuclear Medicine Staff and in partnership with the Enterprise Nuclear Medicine Radiopharmaceutical manufacturing and compounding operation leadership. The position will require development of a Quality Plan and a Quality Manual, describing the objectives and details of the Enterprise Nuclear Medicine Radiopharmaceutical Quality Management System. The position will identify and determine quality requirements of customers across Mayo Clinic enterprise radiopharmaceutical/isotope production and quality control operations. The position requires the incumbent develop efficient and effective frameworks that ensure customer needs are met. The position will require the incumbent to perform site visits as well as work remotely in order to perform enterprise support functions. The incumbent will develop and establish a robust documentation framework for enterprise radiopharmaceutical/isotope production and quality control operations. The incumbent will be responsible for development and establishment of a Quality Assurance Unit ensuring independent quality control of radiopharmaceuticals and isotopes. The position will be responsible for composition and review of product and process specifications. The incumbent will be responsible for development of statistical methods and tools for monitoring radiopharmaceutical production and quality control operations. The position will be responsible for ensuring that production and quality control operations are appropriately monitored. The position will also require that routine Radiopharmaceutical production, Radiopharmaceutical development, and quality control practices comply with the directives in the quality manual. The position will require the incumbent to develop standards and acceptance criteria for vendors supplying materials for radiopharmaceutical/isotope production and quality control operations. The position will also require the incumbent to design and implement a program verifying vendor compliance with requirements as stated in the Quality Manual.

The position requires that the incumbent ensures compliance with both Federal and State CGMP and related regulations related to radiopharmaceutical production. The incumbent will maintain an advanced knowledge of FDA and State quality related regulations. The position will be responsible for maintenance and upkeep of current FDA approved CMC documentation for radiopharmaceutical/isotope production and quality control operations. The position will update and maintain current information stored in Global Summit Review. The position will require a working knowledge of Electronic Common Technical Document composition and submission processes. The position will also require the incumbent develop an appropriate framework and program to ensure that staff working in enterprise radiopharmaceutical/isotope production and quality control operations have sufficient training associated with Good Manufacturing Practice and quality related functions.

The position will require the incumbent communicate with vendors for which radiopharmaceutical/isotope production and quality control operations is an acting Contract Manufacturing Organization (CMO). The position requires that quality agreements are reviewed and complied with while the CMO is active. The position also requirer’s that the incumbent work with the sponsor or sponsor’s representative during a site inspection ensuring compliance with the quality standards expected by the sponsor.

Qualifications
Master’s degree in chemistry or a chemistry-related field, or a Bachelor’s degree in chemistry or a chemistry-related field with a minimum of four years’ experience producing and/or developing PET drug products. Background in analytical chemistry, preferably organic chemistry. Experience working with radioactivity such as in a PET radiochemistry laboratory, nuclear medicine environment, or commercial nuclear pharmacy specializing in PET drug production. Strong word processing and database skills, specifically with Microsoft Word and Excel.

Additional qualifications
Prior experience teaching, training, group interactions and presentations.

Exemption status
Exempt

Compensation Detail
$84,614 – $126,963 / year

Benefits eligible
Yes

Schedule
Full Time

Hours / Pay period
80

Schedule details
40 Hours week. No night or weekend shifts

Weekend schedule
Mondays through Fridays only

International Assignment
No

Site description
Mayo Clinic is located in the heart of downtown Rochester, Minnesota, a vibrant, friendly City : that provides a highly livable environment for more than 34,000 Mayo staff and students. The City : is consistently ranked among the best places to live in the United States because of its affordable cost of living, healthy lifestyle, excellent school systems and exceptionally high quality of life.

Recruiter
Kianne Wohlfert

EOE
As an Affirmative Action and Equal Opportunity Employer Mayo Clinic is committed to creating an inclusive environment that values the diversity of its employees and does not discriminate against any employee or candidate. Women, minorities, veterans, people from the LGBTQ communities and people with disabilities are strongly encouraged to apply to join our teams. Reasonable accommodations to access job openings or to apply for a job are available.

 

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