Senior Specialist, Quality Assurance

  • Regular/Permanent
  • USA / Indiana
  • Telework not possible

Welcome to Orano Med

Orano Med is at the forefront of research in nuclear medicine and is developing new therapies against cancer. Based on its unique expertise in the production of lead-212 (Pb-212) and radiolabeling technologies, Orano Med is developing innovative radioligand therapies which consist of selectively destroying cancer cells while limiting the impact on surrounding healthy cells.
With a solid portfolio of molecules in development capable of targeting various forms of cancer, and a reliable supply chain for Pb-212, Orano Med aims to become a leader in targeted alpha therapies, in particular for patients with currently unmet medical needs.

Job description

Orano Med is seeking a Senior Specialist, Quality Assurance or Quality Assurance Specialist for ATLab Indianapolis, a new state-of-the-art facility for commercial-scale, sterile manufacturing of therapeutic radiopharmaceuticals. This position offers the opportunity to help establish a new facility with high standards for quality, volume, speed, and reliability.

Setup Phase

  • Documents: Draft/review/approve SOPs, other QA documents (SVMP, QAAs, FMECA, Risk Analysis)
  • Review IQ/OQ/PQ for new cleanrooms, equipment, software
  • Tech transfer: PV runs, final report
  • Vendor qualification
  • Recruit employees
  • Relocate to the area by 2023-Q3; Travel <20%

Production Phase
Top Priority: Batch Release

  • Document Control: Release batch record/QC test records
  • Materials: Release from Controlled Storage
  • Manufacturing floor: maintain QA presence; process confirmation
  • Prompt review of documents for batch release
  • React to urgent problems
  • Operational line clearances/AQL inspections
  • Typical shift 3 PM-12 AM; OT, off-shifts if needed

QA Functions

  • Equipment: Review completed PM/RQ
  • Review GMP documents (records, equipment/service logs, certificates)
  • Expert on QMS: speak to management/inspectors
  • Materials: Inspect; Review COAs/acceptance sheets
  • Document Control
  • Qualify staff:
    o Read & Understand
    o Production: gowning, media fills, process
    o Training matrix
  • Work 100% on-site; Travel <10%Continuous Improvement
  • Work with Production/QC/Shipping teams for mutual improvement
  • Internal audits, FMEAs
  • Oversee investigations to resolve equipment/process deviations/OOS/recalls/complaints
  • Coordinate CAPAs/Change Controls; effectiveness evaluation
  • Prioritize time in balancing production timelines with product quality assurances
  • Continue duties from Project Phase as needed

Leadership

  • Set tone in QA Team
  • Embody/promote culture of quality with continuous improvement
  • Example of determination, problem solving, servant leadership
  • Lead toward ambitious goals/timelines

Other duties as needed.

Our Full-Time Benefits

  • Competitive compensation 
  • Health, Dental, and Vision insurance – with generous employer contributions 
  • 401(k) with employer matching and contribution amounts 
  • Life insurance and Short- and Long-Term Disability insurance provided by the company  
  • Generous Paid Time Off and holiday schedules 
  • Numerous Training and Development opportunities 
  • and more…   

Ideal qualifications

Required

Experience

  • QA any industry: 3+ years
  • QA pharmaceutical: 2+ years
  • Aseptic Manufacturing: 1+ years
  • Cleanroom: gowning, cleaning, environmental monitoring, aseptic technique
  • GMP regulations, compendial guidelines

Physical

  • Stand for 6+ hours
  • Wear cleanroom PPE

Preferred

Education

  • BA/BS in a scientific field

Experience

  • Radiopharmaceuticals o FDA: Submission (IND, DMF, NDA); On-site Inspection
  • Performing audits: Internal/External
  • Software Experience with eQMS, eBR, LIMS, BMS
  • New facility: new systems, construction, people

Work Skills

  • High-pressure environment with same-day deadlines; work with urgency
  • Challenging technical problems
  • Strong attention to detail; meticulous documentation
  • Adaptable: independent work, direct supervision, leading a team
  • Efficient but clear oral/written communication; public speaking; answering questions
  • Collaborating with cross-functional teams
  • Extremely organized

Attitude/Leadership

  • Character: intergrity, honesty, respect authority, obey rules/policies/laws
  • Embody safety, quality, customer service, and problem-solving
  • Excellent interpersonal skills
  • Servant Leadership; service attitude
  • Leadership experience with training, motivating, and conflict resolution
  • Make firm decisions in difficult situations
  • Seize opportunities to learn, accept a project, help with a task

Senior Specialist, Quality Assurance

Ref: 2023-13106

Regular/Permanent

Brownsburg

Orano Med is at the forefront of research in nuclear medicine and is developing new therapies against cancer. Based on its unique expertise in the production of lead-212 (Pb-212) and radiolabeling technologies, Orano Med is developing innovative radioligand therapies which consist of selectively destroying cancer cells while limiting the impact on surrounding healthy cells. With a solid portfolio of molecules in development capable of targeting various forms of cancer, and a reliable supply chain for Pb-212, Orano Med aims to become a leader in targeted alpha therapies, in particular for patients with currently unmet medical needs.

Find out more about Orano Med
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