Why Orthofix?
Guided by our organizational values – Take Ownership | Innovate Boldly | Win Together – we collaborate closely with world-class surgeons and other partners to improve people’s quality of life. At Orthofix, we want team members who build relationships and share knowledge, challenge the status quo, and deliver results every day to help us achieve our vision to be the partner in Med Tech.
Our global team of over 1,600 employees brings to market highly innovative, cost-effective, and user-friendly medical technologies that heal musculoskeletal pathologies for patients and the healthcare professionals who treat them. Looking to change people’s lives? Look no further.
JOB PURPOSE
To provide microbiology and chemistry testing services related to manufacturing and sterilization of our products.
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES
1. Perform routine microbiology testing which may include LAL bacterial endotoxin test, bioburden, environmental monitoring, ELISA for BMP-2, microbial identification, histology readings, etc., using established procedures/ protocols.
2. Perform chemical analysis such as titration, pH, conductivity, osmolarity, residual calcium (using flame AA), determination of HCl concentration, determination of formaldehyde concentration, shrink test, and loss on ignition according to procedures/ protocols
3. Perform data entry of routine microbial/ chemistry testing for analysis by Scientists/ Technologists
4. Review, follow, and perform job functions in compliance with established work instructions and adherence with SOPs, including traceable information on device history records
5. Maintain equipment by following procedures, executing preventive maintenance and calibrations per established schedule
6. Track, trend, and publish monthly Environmental Monitoring reports.
7. Conduct Out of Specification (OOS), supports nonconformance's (NCMRs) and CAPA investigations
8. Prepare glassware and understand dilutions for applicable tests
9. Ensure proper handling, storage, and disposal of all waste generated in the laboratory
10. Other incidental duties as assigned
MINIMUM QUALIFICATIONS
Education/Certifications:
11. Associate degree in Microbiology, Chemistry, or other related science
Experience, Skills, Knowledge and/or Abilities:
12. 1-3 years’ experience in a similar laboratory role
13. Effective communication skills
14. Good computer skills
15. Excellent pipetting skills
16. Moderate knowledge of laboratory processes, GLP, ANSI/AAMI and USP Pharmacopeia
17. Moderate knowledge in QSR, FDA and ISO regulations
18. Moderate knowledge in mathematics (percentage, decimals, statistics)
19. Strict attention to details
20. Must be able to work in a team environment and with minimum supervision
21. Adhere to all company rules and requirements
PREFERRED QUALIFICATIONS
Education/Certifications:
22. Bachelor’s degree in Microbiology, Chemistry, or other related science
Additional Experience, Skills, Knowledge and/or Abilities:
23. Medical device or biologic manufacturing
24. Prefer to have knowledge in one or all the following: AATB, QSR, cGMP, ISO 13485, ISO 17025, ISO 11137, ISO 11737, ISO 14644 and USP
PHYSICAL REQUIREMENTS / ADVERSE WORKING CONDITIONS
25. This position requires frequent or continuous moderate lifting of 15-40lbs
26. This position requires frequent or continuous pushing and/or pulling
27. This position requires frequent or continuous standing
28. This position requires frequent or continuous walking
29. This position requires frequent or continuous repetitive motion involving substantial movements of the wrist, hands and/or fingers; or grasping with hands and/or fingers
30. This position requires frequent or continuous bending, stooping, kneeling, or crouching
31. This position requires frequent or continuous exposure to dust, fumes, gases, odors, or other airborne irritants
32. This position requires frequent or continuous exposure to chemicals and/or solvents
The anticipated salary for this position for an employee who is located in California is $;to $;per year, plus bonus, and benefits.
DISCLAIMER