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Specialist, Quality Assurance

5+ years
Not Disclosed
10 Jan. 27, 2025
Job Description
Job Type: Full Time Education: B.Sc, M.Sc, B.Pharm, M.Pharm, LifeScience Graduates Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Specialist, Quality Assurance
Location: Mobile, AL
Company: Jubilant DraxImage, Inc. (dba Jubilant Radiopharma)

Equal Opportunity Employer
Jubilant Radiopharma is an equal opportunity 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.


Company Overview:
At Jubilant Radiopharma, we combine global clinical expertise with a leading pharmacy network to advance nuclear medicine. As an industry leader, we specialize in developing, manufacturing, and distributing high-quality diagnostic and therapeutic agents. Our mission is to improve lives through nuclear medicine on a global scale.


Position Overview:

We are seeking a Specialist, Quality Assurance to join our dynamic team in Mobile, AL. This role offers the opportunity to make a meaningful impact on patient lives by ensuring the highest standards of quality in the manufacturing of radiopharmaceuticals. You will be an integral part of our Quality Assurance team, ensuring compliance with FDA regulations and industry standards, promoting best practices, and driving continuous improvement in our processes.


Key Responsibilities:

  • Daily Inspections & Quality Checks:
    • Perform routine inspections and quality checks on manufacturing processes and equipment to ensure compliance with FDA regulations, cGMP, and industry standards.
  • Documentation & Record Review:
    • Review and approve batch records, test results, and other production documentation to ensure accuracy, completeness, and compliance with applicable regulations.
  • cGMP & Documentation Practices:
    • Promote and ensure adherence to cGMP, good documentation practices (GDP), and data integrity requirements, including compliance with 21 CFR Part 11.
  • Radiation Safety Officer (RSO):
    • Comply with ALARA (As Low As Reasonably Achievable) practices and serve as the Radiation Safety Officer (RSO).
  • Quality Issue Investigation & CAPA:
    • Identify and investigate quality issues, deviations, non-conformances, and CAPA (Corrective and Preventive Actions) in collaboration with manufacturing personnel, ensuring timely resolution.
  • Internal Audits:
    • Conduct internal audits to verify compliance with standard operating procedures and identify opportunities for continuous improvement.

Qualifications:

  • Education:
    • Bachelor's degree in a scientific discipline (chemistry, biology, pharmacy, or a related field).
  • Experience:
    • Minimum of 5 years of experience in quality assurance or regulatory affairs within a pharmaceutical or medical device manufacturing environment.
    • Experience with PET radiopharmaceuticals is preferred.
  • Knowledge & Skills:
    • In-depth knowledge of FDA regulations, GMPs, and other relevant industry standards.
    • Strong attention to detail and ability to maintain accurate records and documentation.
    • Proven ability to investigate and resolve quality issues effectively.

What We Offer:

  • A career, not just a job
  • Career growth and development opportunities
  • Supportive work culture
  • Competitive base salary
  • Comprehensive medical, dental, and vision benefits
  • 401(k) with company matching
  • Paid Time Off and paid holidays
  • Short and long-term disability coverage

Jubilant Radiopharma is committed to building a diverse and inclusive workplace.
We value diverse perspectives, experiences, and backgrounds, and we strive to create an environment where all employees can thrive.


How to Apply:
If you are passionate about making a difference and meet the qualifications, we invite you to apply for the Specialist, Quality Assurance position. We look forward to discussing this exciting career opportunity with you.

For accommodations or assistance in applying, contact Human Resources at 407-455-6700.

Jubilant Radiopharma is proud to be an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status about public assistance, genetic status, or any other status protected by law.