JOB DESCRIPTION

Orano Med is seeking a detail-oriented Quality Assurance Specialist for radiopharmaceutical manufacturing at ATLab Indianapolis (“ATLab IND”), a new facility for commercial-scale manufacturing of sterile therapeutic radiopharmaceuticals.
The Quality Assurance Specialist will be responsible for supporting GMP manufacturing of raw materials and sterile drugs for clinical trials. The individual in this role will review documentation related to raw materials, components, and completed batch records followed by giving a disposition of each. Assist with quality systems improvements.

IDEAL QUALIFICATIONS

Qualifications Required

EDUCATION

• Associate’s degree, bachelor’s degree preferred

EXPERIENCE

• 2+ years of quality assurance experience
• 1+ years of quality assurance experience in Pharmaceuticals or related industry
• 1+ years of Aseptic Manufacturing
• Cleanroom: gowning, cleaning, environmental monitoring, and aseptic technique
• Experience in writing SOPs and other associated GMP documentation.
• Proficient in Microsoft Office, Excel, and PowerPoint
• Excellent written and verbal communication skills
• GMP regulations and compendial guidelines
• Able to easily switch between multiple ongoing projects, adjusting priorities based on business needs

EDUCATION

• BA/BS in a scientific field

EXPERIENCE

• Radiopharmaceutical experience
• FDA: Submission (IND, DMF, NDA); onsite inspections

• Inspect, review documentation, and release incoming raw materials

and packaging components.

• Update Quality SOP’S and perform secondary review of

documentation.

• Perform area release for manufacturing, as needed.
• Oversee sterile manufacturing process, provide sterile gowning and

practices instruction.

• Review production batch records, logbooks, and associated

documentation to assess completeness, accuracy, and compliance

with SOPs.

• Review of equipment and instrumentation documentation in support of

GMP manufacturing and testing operations.

• Scanning manufacturing documentation such as batch records, raw

materials, audits, investigations, CAPA, and change control.

• Release/disposition GMP products for Macrocyclics and OM.
• Follow up on investigations, CAPAs and change controls for time

completion.

• Review of documentation related to technology transfer from R&D for

manufacturing activities.

• Perform Internal audits of GMP labs and other non-GMP processes

as directed.

• Additional responsibilities as assigned