Quality Assurance Technician

Description

Orano Med


Orano Med has developed new processes for producing high-purity lead-212, a rare radioactive isotope. Lead-212 is currently at the heart of promising research projects in nuclear medicine to develop new treatments against cancer. The innovative approach, known as targeted alpha therapy (TAT), recognizes and destroys cancer cells while limiting the impact on nearby healthy cells.


The QA Specialist supports 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.


Key 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 / instrumentation documentation in support of GMP 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
• Other duties as assigned.

Requirements
All candidates must meet the following minimum requirements in order to be considered for this opportunity. Candidates who exceed minimum qualifications may be considered for a higher-level position.


Minimum Qualifications:

• High Diploma/GED, Bachelor's degree in science related field

Required Skills and Competencies:

• Have experience in writing SOPs and other associated GMP documentation
• Proficient in Microsoft Office, Excel, and Power Point
• Strong written and verbal communication skills.
• Strong organization skills.
• Able to easily switch between multiple ongoing projects, adjusting priorities based on business needs.

Differentiating Qualification(s):

Specific lab experience