Orano Med Theranostics
Orano Med is seeking a detail-oriented GMP Manufacturing Technician
We are seeking a highly motivated GMP Manufacturing Technician who will be responsible for non-clinical GMP manufacturing, maintaining the GMP suite and GMP equipment, as well as ensuring that all necessary documentation is maintained accurately in accordance with all applicable regulations. The GMP Manufacturing Technician assists with clinical material manufacturing as well as preparation for clinical product manufacturing. This position conducts routine maintenance of areas and equipment and maintains accurate records of operations within GMP suite.
Key Responsibilities
- Follow written procedures for non-clinical manufacturing
- Complete batch records, forms, equipment logs, and other production records as directed per company procedures and GMP guidelines
- Work concurrently with Quality Assurance (QA) and Quality Control (QC) personnel to deliver a high-quality product
- Follow and adhere to production schedules and timelines
- Execute room and equipment preparation for manufacturing operations
- Perform room sanitization activities as needed to maintain controlled environment conditions
- Participate in isolator and room monitoring
- Participate in room and isolator preparation for manufacturing
- Stocking materials in the GMP labs
- Identify and communicate process and equipment failures during manufacturing to supervisor and equipment team
- Identify process errors and report to supervisor
- Participate in deviation investigations and follow management guidance for corrective and preventive actions
- Clean, sanitize and sterilize equipment and components to support production operations
- Initiate cleaning procedures for the labs, perform routine maintenance on equipment, restock labs.
- Demonstrate ability to perform tasks with minimal guidance once trained
- Complete training on Master Batch Records, Formulation Records, and Protocols related to non-clinical manufacturing
- Complete on the job training for cleaning, gowning, GMP suite access, and equipment
Orano strives to provide a total compensation package that brings value to our employees. We also offer highly competitive health and wellness programs, 401(k) contributions, and industry leading paid time off.
Education & Experience
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:
- Associate/Bachelors degree in a related field or comparable work experience
- 0 - 1+ year's experience
- Chemistry or Microbiology lab experience, knowledge of chemical safety and lab hygiene
Required Skills & Competencies:
- Chemistry or Microbiology lab experience, knowledge of chemical safety and lab hygiene
- Ability to work side by side with the quality assurance department.
- Excellent documentation skills and attention to detail
- Excellent communication, problem-solving and organizational skills
- Ability to follow written and verbal instruction and work under supervision
- Computer literacy and proficiency with Microsoft Office
- Ability to understand and exercise basic mathematical calculations and more complex calculations with various available tools and calculators
- Ability to work in a very fast-paced, high-growth team environment
- Ability to perform duties using proper aseptic technique
Preferred Skills & Competencies:
- Communications Skills, Ability to Learn, Initiative, Dependability, Productivity, Quality of Work, Safety, Teamwork.
