QA Specialist III

Orano; Brownsburg (IN); On-site; USD 70,000 - 95,000; Full time

Benefits offered by this job

Competitive compensation

Health, Dental, and Vision insurance

401(k) with employer matching

Life insurance and Disability coverage

Generous Paid Time Off and holidays

Training and Development opportunities

Job summary

Orano Med is seeking a Quality Assurance Specialist to ensure products and processes meet regulatory standards. You will support production and QC testing, perform audits, review documentation, investigate deviations, and drive continuous improvement across the site.

Responsibilities include leading internal audits, handling CAPA activities, coordinating training, and maintaining records in alignment with GMP and FDA/ISO requirements.

Qualifications

• Bachelor’s degree in scientific or technical discipline preferred.
• Four plus years of experience in a regulated industry (pharma, biotech, medical devices, food).
• Experience with GMP/GLP and quality standards.

Responsibilities

• Audit production and QC processes and review deviations.
• Author, review and approve batch records and SOPs.
• Lead investigations for non-conformances and CAPA actions.
• Collaborate with cross-functional teams to support quality initiatives.
• Lead site internal and customer audits and support regulatory inspections.

Skills

GMP/GLP knowledge

Attention to detail

Quality systems

Strong communicator

Team collaboration

MS Office proficient

Education

Bachelor’s degree in scientific or technical discipline

Tools

Quality Management System (QMS)

Microsoft Office

Job description

Orano Med, a subsidiary of Orano USA, is at the forefront of research in nuclear medicine and is developing new therapies against cancer. Based on its unique expertise in the extraction and purification of lead-212 (Pb-212) and radiolabeling technologies, Orano Med is developing innovative Pb-212-based treatments which consist of selectively destroying cancer cells while limiting the impact on surrounding healthy cells.

With a solid portfolio of development projects covering a diverse range of biological molecules capable of recognizing and targeting various forms of cancerous tumors, and a reliable supply chain for Pb-212, Orano Med aims to become a leader in targeted alpha therapies, in particular addressing needs of patients currently without effective therapeutic solutions among the existing approaches.

Position Summary

The Quality Assurance (QA) Specialist is responsible for ensuring the products and processes meet established quality standards and regulatory requirement. This role supports production and quality control (QC) testing operations by performing audits, reviewing documentation, investigating deviations, and promoting continuous improvement across the site.

Key Responsibilities

• Monitor and enforce compliance with internal procedures, industry standards, and regulatory requirements (e.g., FDA, ISO, Good Manufacturing Practices (GMP)).
• Conduct in-process inspections, environmental monitoring reviews, and final product reviews.
• Author, review and approve batch records, procedures, and other quality-related documentation.
• Act as lead investigator for non-conformances, deviations, customer complaints, and assist in root cause analysis, and corrective/preventive actions (CAPA).
• Collaborate with cross-functional teams (e.g., Production, QC, Facilities, etc.) to support quality initiatives andresolve issues.
• Lead site internal audits and partner audits along with supportexternal inspections.
• Serve to corrdinate training for new personnel and provide guidance to site QA procrdures and best practices.
• Maintain records and documentation in accordance with company policies and regulatory standards.
• Support qualification and validation activities (e.g., equipment, systems, processes)
• Escalate quality concerns appropriately and timely to ensure product integrity and patient safety.
• Act as backup in assigning tasks and managing quality initiatives in absence of department leaders.
• Perform other related duties as assigned or required.

Requirements

Qualifications

Education

• Bachelor’s degree in scientific or technical discipline (e.g., Biology, Chemistry, Engineering) preferred.
• Four plus years of experience in a regulated industry (e.g., pharmaceutical, biotech, medical devices, food manufacturing)

Experience

• Strong understanding of GMP, GLP, and other relevant quality standards.
• Strong attention to detail and organizational skills.
• Proficiency in quality management systems and Microsoft Office Suite.
• Excellent written and verbal communication skills.
• Ability to work independently and collaboratively in a team environment.
• Flexibility to work assigned shift and occasional weekends or holidays as needed.

Work Skills

• Demonstrate ability to mobilize cross-functional teams through influence and inspiration
• Strong problem-solving skills and the ability to prioritize task effectively.
• Proficient with word processing, spreadsheet, and database software, and standard business communication tools (e.g., Microsoft Outlook).
• Ability to prioritize and manage a high volume of complex activities with rapidly changing priorities.
• Excellent written and verbal communication skills in English.
• Detail-oriented with the ability to meticulously compare details in multi-page documents while managing urgent customer needs.
• Demonstrated team participation with leadership behaviors is preferred.

Attitude

• Character: integrity; honesty; respect authority; obey rules/policies/laws
• Exemplify values of safety, quality, customer service, and problem solving
• Excellent interpersonal skills
• Servant leadership; service attitude
• M ake firm decisions in difficult situations
• Seize opportunities to learn, accept a project, help with a task
• Identify problems, take initiative, overcome obstacles; strive toward ambitious goals/timelines

• 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…

Present in the United States for 60 years, Orano USA is a leading technology and services provider to the U.S. commercial and federal markets.

Orano’s activities in the U.S. include developing uranium enrichment facility in Oak Ridge, TN ; packages and transportation of uranium & nuclear fuel assemblies ; fabricating & installing used nuclear fuel dry storage canisters and casks, conducting pool-to-pad used nuclear fuel transfers ; providing solutions to the National Labs and to the Dept of Energy ; and supplying U.S. nuclear energy utilities with uranium, conversion, and enrichment services.

In the nuclear medicine field, Orano Med is at the forefront of research in nuclear medicine and is developing a new generation of targeted therapies against cancer using the unique properties of lead-212.

In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.

This position requires a pre-employment background check and drug screening.

Orano is an Equal Opportunity Employer. Orano and all subsidiaries abide by applicable legal requirements. We ensure that all personnel actions such as recruitment, compensation, career development, benefits, and company-sponsored training are administered without regard to race, color, religion, sex, national origin, age, disability, sexual orientation, protected veteran, or other protected status.