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    Document Control Specialist - Irvine, United States - Orthofix

    Orthofix
    Orthofix Irvine, United States

    1 week ago

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    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

    How you'll make a difference?

    As a subject matter expert, the Document Control Specialist will coordinate document control activities related to the document management and data management systems. This position is also responsible for interfacing with all departments to organize, maintain and edit documentation in support of products and quality system processes.

    What will your duties and responsibilities be?

    The following are the essential functions of this position. This position may be responsible for performing additional duties and tasks as needed and assigned.
    • Coordinate the activities of Document Control, including the tracking, release, distribution, and auditing of controlled documents.
    • Organize and facilitate approval process of Change Orders, including distribution and archiving of final documents whether hard copy or electronic.
    • Review completeness of documentation for accuracy and consistency.
    • Maintain compliance activities associated with the Quality Management System (QMS) to comply with applicable regulations.
    • Reviewing completeness and processing of deviations.
    • Collaborate with subject matter experts effectively to prepare controlled documents per our GDP procedures.
    • Managing GTIN Database.
    • Compilation of monthly document control metrics.
    • Effectively follow SOPs, policies, and FDA Good Manufacturing Practices.
    • Provides support for the Quality Systems and Regulatory departments during internal and external audits and actively participate in department activities.
    • Support the CAPA program as needed.
    • Scan, file and/or box documentation (i.e., batch records, Special Request etc.) and verify documentation for destruction, per our established procedure as applicable per site.
    • Maintaining External Standards and processing of requests for updates or new purchases
    • Perform other duties as assigned.
    • Assist in technical projects as needed.
    What skills and experience will you need?

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

    Education/Certifications:
    • High School Diploma or equivalent
    Experience, Skills, Knowledge and/or Abilities:
    • 3+ years' experience within Document Control
    • Related experience working with Quality System or technical documentation systems, preferably in an FDA regulated environment
    • Working knowledge of ISO and FDA document management guidelines, regulations, and standards
    • Outstanding attention to detail
    • Strong interpersonal skills and ability to work with others in a positive and collaborative manner
    • Demonstrated ability to work accurately, follow instructions/schedules/timelines and handle multiple priorities
    • Ability to utilize multiple word-processing and database applications including MS Office applications Word, Excel, and other software applications as necessary
    What qualifications are preferred?

    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 preferred
    Additional Experience, Skills, Knowledge and/or Abilities:
    • Ability to work independently
    • Type 45 WPM
    • Excellent Customer Service
    • Problem solving Skills
    • Prior knowledge and experience with electronic document management systems (DMS), learning management systems (LMS), product lifecycle management systems (PLM) or enterprise resource planning systems (ERP) is preferred
    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 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.
    • This position requires frequent or continuous sitting and/or standing.
    • This position requires frequent or continuous walking.
    • This position requires frequent or continuous moderate lifting of 15-40lbs.

      The anticipated base hourly rate for an employee who is located in California this position is $28.00 to $33.00 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.
    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.
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