- Perform visual inspection of products and components prior to packaging, and perform final packaging activities of for finished goods
- Kitting of controlled materials to the Final Packaging batch records
- Complete system transactions where applicable (for inventory control purposes)
- Supports ERP move and material transactions are completed timely.
- Follow Company policies and procedures compliance.
- Perform rework of returned products.
- Monitor inventory of final packaging components and communicating the status with the Planning Dept.
- Assist with shipping and receiving of product to and from sterilization facilities
- Perform Autoclaves duties
- Requisition and restocking of supplies for the Labeling Area.
- Perform other job duties as assigned.
- High School Diploma or equivalent required
- 0 - 2 years of experience in an FDA regulated manufacturing/controlled environment, preferably in a Medical Device Experience or human-tissue assembly/production.
- Must be able to speak, write and read English with excellent understanding
- Ability to adapt to a fast-paced environment
- Individual must be punctual and have reliable attendance
- Individual must be cooperative and willing to work in a team environment
- Must be able to follow direction provided by authorized supervision
- Knowledge of Good Manufacturing Practices (GMP)
- Ability to perform repetitive task consistently and proficiently
- Must be able to interact with peers, Manufacturing Supervisor/Manager
- Must be proficient in tasks performed (after suitable training period) and have attention to detail
- Ability to work overtime, including evenings, weekends and holidays
- Ability to utilize a computer, telephone, label printer and copy machine as well as other general office equipment.
- Strong computer skills are required.
- No additional requirements
- Medical device manufacturing/assembly/packaging experience
- Experience working in a controlled environment (preferably ISO class 5, 7 & 8 or better)
- This position requires frequent or continuous bending, stooping, kneeling, or crouching.
- This position requires frequent or continuous moderate lifting of 15-40lbs.
- This position may require some pushing and/or pulling.
- 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.
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Final Packaging Technician I - Irvine, United States - Orthofix
Description
Why Orthofix?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
JOB PURPOSE
The Final Packaging Technician I is responsible for packaging finished goods product to support inventory demands. Assisting Manufacturing Supervisor / Manager in overseeing production team to ensure all production operations are in compliance with SOP's, current GMPs, QSR, GTP, and ISO standards as well as company procedures.
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES
The following are the essential functions of this position. This position may be responsible for performing additional duties as tasks as needed and assigned.
The requirements listed below are representative of the education, knowledge, skill and/or ability required for this position.
Education/Certifications:
The education, knowledge, skills and/or abilities listed below are preferred qualifications in addition to the minimum qualifications stated above.
Education/Certifications:
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 in order 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.
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.