Production Scientist 1
MiraVista Diagnostics is actively seeking a Production Scientist
If you’re interested in joining the MiraVista team, please apply for this position using the form on our website Career Center or email your resume to firstname.lastname@example.org if you have any problems with the web form.
Positions Overview for Production Scientist
Responsibilities include formulation of buffers, purifying antibodies, labeling antibodies with detector molecules, assembling IVD/LDT kits and method verification and validation. Plan and schedule day to day manufacturing
Responsible for compliance with MiraVista Diagnostics’ policies and procedures.
Job Responsibilities for Production Scientist
- Plan and schedule day to day manufacturing. Direct resources to complete tasks on time.
- Establish and maintain Manufacturing Operations QMS documents (SOP, WI, etc.)
- Prepare technical SOPs as required for review and approval.
- Participate on project teams as Technical Lead and Manufacturing representative.
- Develop and execute process verifications and validations.
- Write GMP documents related to product manufacturing and quality assurance, progress reports, publications, SOP’s, MSDS, etc.
- Positively interact with staff in R&D, QA, Regulatory Affairs and the Clinical Lab.
- Be part of team tasked with improvement/development of diagnostic products.
- Equipment function checks and related functional verification with data entry for various pieces of laboratory equipment. Laboratory equipment preventative maintenance tasks.
- Ensure work is aligned with all relevant quality requirements.
Qualifications for Production Scientist
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
- Minimum BS in Life Sciences or a related science field; Experience in diagnostic industry is preferred.
- Minimum 5 years of experience with FDA/GMP regulated medical device manufacturing.
- ELISA and or lateral flow experience with a proven track record of maintaining sufficient inventory to meet internal and external demands.
- Proven ability to successfully transfer IVD products from R&D into production.
- Experience in: GMP documents (Master Device Records, Device History Records, SOP’s).
- Experience with electronic QMS and manufacturing ERP systems.
- Good organizational skills.
- Must be able to work productively and independently in an interdisciplinary team environment.
Apply today for the Production Scientist position at MiraVista Diagnostics in Indianapolis. Please use the form on the website Career Center (or email your resume to email@example.com if you have any problems with the web form).
MiraVista Diagnostics was established in 2002 and operates a fast-paced onsite clinical laboratory in Indianapolis where we process more than 100,000 diagnostic tests for serious fungal infections each year.