Quality assurance officer job description

Responsibilities include, but are not limited to:

• Monitors, reviews, and evaluates clinical records, concurrently and retrospectively, to ensure compliance with clinical policy, and regulatory and accreditation guidelines.
• Reports audit or clinical findings to appropriate staff or others to ensure appropriate outcome and/or follow-up for improvement as indicated.
• Assists the Clinical Director in assessing, planning, implementing, and evaluating the performance improvement programs of the organization.
• Assists and/or coordinates clinical performance improvement audits as requested by the Clinical Director and/or Quality Assurance Committee.
• Participates in performance improvement meetings and reports findings to the Clinical Director and Executive Management.
• Evaluates documentation for appropriate interventions and teaching based on the patient’s clinical status.
• Actively participates in established agency committees.
• Attends regular and mandatory agency meetings, case conferences and in-service education programs.
• Maintains confidentiality and complies with HIPPA regulations for all patients, employees, and agency.
• Ensures compliance with CMS & The Joint Commission’s Conditions of Participation and all other regulatory requirements.
• Other job duties as assigned

Job Type:
Part-time, Contract

Application Question(s):

• Must have Medical Coding/QA experience.
• Minimum Requirement: RN with active and unencumbered MI License, 1yr current Home Health Experience.

Work Location:
One location + Remote

About Care Seniors:

“Restoring healthy lives one block at a time.”We have always pivoted our services and programs in this guide. Care Seniors, LLC is totally dedicated in rendering superb quality service to its clients so that health is restored to them. Through the years, we have grown from a small home care facility to one that now encompasses four counties. Our presence in Lucas, Ottawa, Wood, Fulton and Henry counties is a testament that more and more clients have trusted us with our wide range of services.Care Seniors, LLC believes that the growth in our business is not solely just the work of us. It is due in part of the satisfied clients that we have worked together with. It is through the word of mouth that we have grown our business. It was our clients in the past that have helped us market our brand—the brand which is now known across the four counties and still continues to grow.With the growing number of clients that are coming to us for help, we are even more challenged to improve our services. We see the growing number of new clients as a proof of the trust that our previous clients have on us, as they influence others to seek for better home health services from us. We will continue to grow, and we will continue to polish the sterling name we have etched in our client’s hearts.

Responsibilities

Under the supervision of the

Director of the Human Gene and Cell Therapy Facility (HGCTF), you will be responsible for the day-to-day Good

Manufacturing Practices (GMP) quality assurance compliance activities including

document control.

Qualifications

+ Bachelor of Science Degree or Master's degree in Biology, Chemistry, or related field and a minimum of one year of GMP quality assurance experience.

+ Previous experience directly involved with federal regulations regarding GLP and GMP.

+ Strong interpersonal communication skills to effectively and diplomatically interact with physicians, staff, administration & sponsors.

+ Demonstrated skill in gathering pertinent data, preparing narrative reports, statistical reports, charts, graphs, and tables.

+ Demonstrated ability to carry out analytical tasks, to identify and define issues and alternatives, to resolve problems, and to draw logical conclusions.

+ Demonstrated skill in reviewing data and material compiled by others for completeness and accruacy to ensure that incorrect/incomplete data is corrected.

+ Ability to work on a diverse variety of projects simultaneously, organize multiple projects for efficiency and cost-effectiveness.

+ On occasion, ability to work flexible hours. Ability to attend off-site staff meetings, conferences and investigator meetings.

+ Strong oral and written communication skills.

+ Exceptional database and computing skills.

+ Working knowledge of some medical and scientific terminology for protocol abstracting and conversation with research personnel.

+ Demonstrated skills with personal computers, spreadsheets, databases and word processing applications for the maintenance of administrative records, analysis of data, and the preparation of reports.

+ Demonstrated skill in utilizing programs such as Word, Excel, and other database software. Ability to learn other systems/software as required.

+ Demonstrated knowledge of FDA Good Laboratory Practice, Good Tissue Practice and Good Manufacturing Practice guidelines.

+ Demonstrated ability to develop and monitor quality improvement plans and SOPs.

UCLA is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected Veteran status.

UCLA Health welcomes all individuals, without regard to race, sex, sexual orientation, gender identity, religion, national origin or disabilities, and we proudly look to each person's unique achievements and experiences to further set us apart.

RESPONSIBILITIES

I. JOB SUMMARY/RESPONSIBILITIES:

• In collaboration with the Radiochemist, responsible for the operations of the cyclotron facility including isotope production, and synthesis. Ensures operations comply with regulatory requirements and the policies and procedures of The Queen's Medical Center (QMC).

• In collaboration with Radiation Safety Officer, ensures compliance with radiation safety program and policies in the manufacture and distribution of quality positron emitting radiopharmaceuticals. Coordinates and leads all quality assurance programs in performance metrics and guidelines within the Cyclotron Lab specific to the production of F18 Fludeoxyglucose based on the QMC (Abbreviated New Drug Application) ANDA.

• Applies quality assurance (QA) processes and procedures at the site level to ensure product quality and regulatory compliance with 21 CFR Part 212 and related regulations and regulatory guidance.

• Serves as the Quality Assurance Officer of the cyclotron facility.

II. TYPICAL PHYSICAL DEMANDS:

• Essential: standing, walking, finger dexterity, seeing, hearing, pushing/pulling up to 50 pounds of force; frequent gripping of an object.

• Frequent: speaking; reaching below shoulder level; repetitive arm/hand motions.

• Occasional: sitting, stooping/bending, kneeling, squatting, twisting body, lifting and carrying weight of 20 pounds up to 30 pounds; reaching above and at shoulder level.

III. TYPICAL WORKING CONDITIONS:

• Not substantially subjected to adverse environmental conditions.

• Work involves handling hazardous material.

IV. MINIMUM QUALIFICATIONS:

A. EDUCATION/CERTIFICATION AND LICENSURE:

• Current Hawaii State license as a Pharmacist.

• Completion of a Nuclear Pharmacy program. If program is not completed upon hire, must have prior nuclear medicine experience and completion of a Nuclear Pharmacy program within one (1) year of entrance into the position.

• Recognition as a Board Certified Nuclear Pharmacist by the Nuclear Regulatory Commission (NRC) under The Queen's Medical Center facility preferred.

B. EXPERIENCE:

• Two (2) years experience as a radio-pharmacist at a cyclotron (radiopharmaceutical-PET) facility preferred.

• Experience to demonstrate the following:

o Knowledge and ability of cyclotron production of radioisotopes.

o Knowledge and familiarity with PET cyclotron requirements including GMP and ANDA compliance issues.

o Proficient in a variety of automated and non-automated synthesis procedures and processes.

o Proficient in a variety of computer and lab equipment.

• Ability to initialize and maximize system performance for both cyclotron and synthesis units preferred.

• Cyclotron lab administration experience preferred.

• Research experience preferred.

• CTI cyclotron experience preferred.

• CTI synthesis module experience preferred.

Equal Opportunity Employer/Disability/Vet