We are a leading global spine and orthopedics company with a premier portfolio of biologics, innovative spinal hardware, bone growth therapies, specialized orthopedic solutions and a leading surgical navigation system. Our combined company is over 1,600 strong, with products distributed in 68 countries worldwide and a global R&D, commercial and manufacturing footprint, and this is just the beginning!
Come join our global team of dedicated professionals who through their extraordinary efforts demonstrate every day their commitment to our mission of improving the lives of patients. At SeaSpine and Orthofix our culture is built around Integrity and the core beliefs we live by: Exceed Expectations, Work Together, Be Respectful, Get Lean and Have Fun!
How you’ll make a difference:
The technician is responsible for the demineralization process and assists in completing the build plan and forecast demands. Responsible for critical equipment (used for demineralization) and promotes a team environment. The technician is responsible for ensuring all demineralization operations are in compliance with SOP’s, current GMPs, QSR, GTP, and ISO standards as well as company procedures.
Your key responsibilities
- Follow company policies and compliance procedures.
- Support preparation and verification of components, tools and equipment.
- Support formulation build of products.
- Follow SOP requirements for cleaning, labeling of processed items and equipment teardowns after processing is completed.
- Assist in organizing delivered gowning supplies from approved vendor and stocking of gowning supplies in the Gowning Room.
- Support the demineralization process & activities as scheduled by the Line Lead and Supervisor.
- Prepare and weigh out NDBM/NDBF per the work instruction.
- Setup and assemble demineralization vessels, tools, equipment and workstations.
- Prepare water and acid for NDBM/NDBF.
- Perform visual check of HCL, buffer, and RO/DI Water for each station prior to start of process as well as during the process, to ensure chemical levels are to specifications.
- Setup the Laminar Airflow stations for post demineralization activities.
- Transfer demineralized DBM to trays, label and load trays into freezer.
- Support ERP move and complete material transactions.
- Assist with review of manufacturing related documentation.
- Monitor HCL, buffer, NDBM/NDBF inventory and submit Kanban cards when appropriate.
- Assist with general daily cleaning, restocking supplies, daily environmental/equipment monitoring in Demin area and cleanroom. Perform system transactions where applicable.
- Assist in main clean room activities as required and perform other duties as assigned.
Who you are
- High School Diploma or equivalent required
- 0-1 of experience in an FDA regulated manufacturing environment, preferably in a Medical Device manufacturing environment
- Individual must be punctual and have reliable attendance
- Strong mathematical skills
- Knowledge of Good Manufacturing Practices (GMP), Quality System Regulation (QSR) and International Organization for Standardization (ISO)
- Individual must be cooperative and willing to work in a team environment
- Must be able to follow direction provided by authorized supervision
- Demonstrates ability to adapt to fast-paced, team-oriented work environment
- Ability to analyze, troubleshoots, and resolves problems/issues as they arise
- Must be willing to learn different jobs in the manufacturing environment
- Must be able to perform repetitive task(s) consistently and proficiently
- Must be able to speak and read English with excellent understanding
- Must be able to keep legible and correct documentation of activities
- Must be proficient in tasks performed (after suitable training period) and have attention to detail
- Ability to utilize a computer, telephone, label printer and copy machines as well as other general office equipment.
- Ability to work overtime, including evenings, weekends, and holidays
- High School diploma or an Associate Degree in a technical or science discipline preferred.
- Basic understanding of Lean Manufacturing and Continuous Improvement preferred.
- Uphold teamwork, excellent communication, and interpersonal skills.
- Experience working in a controlled environment (preferably ISO class 5, 7 & 8 or better) preferred.
- Oracle ERP experience preferred.
- Agile Product Lifecycle management software preferred.
The anticipated base hourly rate for an employee who is located in California for this position is $19.72 to $21.25 per hour plus bonus, and benefits. The final pay offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and years of experience within the job, the type and years of experience within the industry, education, etc. The Company is a multi-state employer, and this pay scale may not reflect the pay scale for an employee who works in other states or locations.
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.