Description

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 unrivaled 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

The following are the essential functions of this position. This position may be responsible for performing additional duties and tasks as needed.

• 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.

• 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

• Perform data entry of routine microbial/ chemistry testing for analysis by Scientists/ Technologists

• Review, follow, and perform job functions in compliance with established work instructions and adherence with SOPs, including traceable information on device history records

• Maintain equipment by following procedures, executing preventive maintenance and calibrations per established schedule

• Track, trend, and publish monthly Environmental Monitoring reports.

• Conduct Out of Specification (OOS), supports nonconformance's (NCMRs) and CAPA investigations

• Prepare glassware and understand dilutions for applicable tests

• Ensure proper handling, storage, and disposal of all waste generated in the laboratory

• Other incidental duties as assigned

MINIMUM QUALIFICATIONS

The requirements listed below are representative of the education, knowledge, skill and/or ability required for this position.

Education/Certifications:

• Associate degree in Microbiology, Chemistry, or other related science

Experience, Skills, Knowledge and/or Abilities:

• 1-3 years' experience in a similar laboratory role

• Effective communication skills

• Good computer skills

• Excellent pipetting skills

• Moderate knowledge of laboratory processes e.g., GLP, ANSI/AAMI and USP Pharmacopeia

• Moderate knowledge in QSR, FDA and ISO regulations

• Moderate knowledge in mathematics (percentage, decimals, statistics)

• Strict attention to details

• Must be able to work in a team environment and with minimum supervision

• Adhere to all company rules and requirements

PREFERRED QUALIFICATIONS

The education, knowledge, skills and/or abilities listed below are preferred qualifications in addition to the minimum qualifications stated above.

Education/Certifications:

• Bachelor's degree in Microbiology, Chemistry, or other related science

Additional Experience, Skills, Knowledge and/or Abilities:

• Medical device or biologic manufacturing

• 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

The physical requirements listed in this section include, but are not limited, to the motor/physical abilities, skills, and/or demands required of the position to successfully undertake the essential duties and responsibilities of this position. In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to allow qualified individuals with a disability to perform the essential functions and responsibilities of the position.

• This position requires frequent or continuous moderate lifting of 15-40lbs

• This position requires frequent or continuous pushing and/or pulling

• This position requires frequent or continuous standing

• This position requires frequent or continuous walking

• 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

• This position requires frequent or continuous bending, stooping, kneeling, or crouching

• This position requires frequent or continuous exposure to dust, fumes, gases, odors, or other airborne irritants

• 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 $26.69 to $33.08 per year, plus bonus, and benefits.

DISCLAIMER

The duties listed above are intended only as representation of the essential functions of this position. The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or a logical assignment to the position. The job description does not constitute an employment agreement between the employer and employee and is subject to change at the sole discretion of the employer. Nothing in this document alters an employee's at-will employment status.

We are committed to providing equal employment opportunities to all employees and applicants without regard to race (including traits historically associated with race, such as hair texture and protective hairstyles, including braids, locks, and twists), ethnicity, religion, religious creed (including religious dress and grooming practices), color, caste, sex (including childbirth, breast feeding, and related medical conditions), gender, gender identity or expression, sexual orientation, national origin, ancestry, citizenship status, uniform service member and veteran status, marital status, pregnancy, age (40 and over), protected medical condition (including cancer and genetic conditions), genetic information, disability (mental and physical), reproductive health decision-making, medical leave or other types of protected leave (requesting or approved for leave under the Family and Medical Leave Act or the California Family Rights Act), domestic violence victim status, political affiliation, or any other protected status in accordance with all applicable federal, state, and local laws.

This policy extends to all aspects of our employment practices including, but not limited to, recruiting, hiring, discipline, termination, promotions, transfers, compensation, benefits, training, leaves of absence, and other terms and conditions of employment.

Since 1980, Orthofix has evolved and grown to become one of the leading medical device companies with a spine and orthopedics focus in the world. Our newly merged Orthofix-SeaSpine organization is a leading global spine and orthopedics company with a comprehensive portfolio of biologics, innovative spinal hardware, bone growth therapies, specialized orthopedic solutions, and a leading surgical navigation system. Our products are distributed in 68 countries worldwide.

Our medical device company is headquartered in Lewisville, Texas, and has primary offices in Carlsbad, CA, and Verona, Italy. Our combined company's global R&D, commercial and manufacturing footprint also includes facilities and offices in Irvine, CA; Toronto, Canada; Sunnyvale, CA; Wayne, PA; Olive Branch, MS; Maidenhead, UK; Munich, Germany; Paris, France; and São Paulo, Brazil.

Founded in Verona, Italy, and now headquartered in Lewisville, Texas, Orthofix is proud to be recognized as the 8th Largest Orthopedic Medical Device Company in the World by Medical Design & Outsourcing magazine. Orthofix is committed to improving patients' lives and delivering innovative, quality-driven solutions that empower physicians and healthcare organizations to meet the needs of their patients every day.

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