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.
Responsibilities
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
Qualifications Required
Education
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
Physical
Education
Experience
Please Note: The provided salary information is a guideline. Your offered salary is based upon experience, qualifications, geographic location, as well as market and business considerations.
Salary range annually: $60,000 - $80,000