Document Control Specialist

1 week ago

Carlsbad, United States Orthofix Full time
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 $25.72 to $33.48 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.

  • Document Control Specialist

    3 months ago

    Carlsbad, United States Meet Full time

    The Document Control Specialist manages and maintains quality-related documentation, including SOPs and work instructions. This role ensures compliance with regulatory standards, oversees version control, and facilitates communication and training on document changes. The Specialist supports internal and external audits, utilizes Electronic Document...

  • Senior Document Control Specialist

    1 month ago

    Carlsbad, United States Orthofix Full time

    Job DescriptionAt Orthofix, we are seeking a highly skilled Senior Document Control Specialist to join our team. As a key member of our Quality Management team, you will be responsible for ensuring the accuracy and completeness of our documents and records.Key Responsibilities:Perform clerical and computer duties necessary to process, distribute, and...

  • Document Management Specialist

    1 month ago

    Carlsbad, New Mexico, United States Precision NDT LLC Full time

    Job SummaryAs a Document Control Specialist at Precision NDT LLC, you will be responsible for overseeing the management and storage of company documents. This includes scanning, imaging, and organizing documents, as well as archiving inactive documents and ensuring compliance with laws and regulations. Additionally, you will be responsible for training...

  • Quality Control Specialist

    1 month ago

    Carlsbad, California, United States Eastridge Full time

    Job SummaryEastridge Workforce Solutions is seeking a skilled Quality Control Specialist to join our team. As a key member of our laboratory team, you will be responsible for performing and documenting QC Sofia Testing of WIP Production Lots and special evaluation assignments.Key Responsibilities:Perform and document QC Sofia Testing of WIP Production Lots...

  • Scientist II, Quality Control Specialist

    4 weeks ago

    Carlsbad, California, United States V R Della Infotech Inc Full time

    Job Title: Scientist II, Quality Control SpecialistJob Summary:V R Della Infotech Inc is seeking a highly skilled Scientist II, Quality Control Specialist to join our team in Carlsbad. As a key member of our Biosciences Division, you will play a critical role in performing Quality Control assays and experiments on molecular biology reagents for global use in...

  • Electronics and Controls Specialist

    4 weeks ago

    Carlsbad, United States Salado Isolation Mining Contractors Full time

    Job Summary:Salado Isolation Mining Contractors is seeking a skilled Electronics and Controls Specialist to join our team at the Waste Isolation Pilot Plant in Carlsbad, NM. The successful candidate will have the ability to perform a wide range of tasks requiring experience and knowledge of Electronics, Calibration, Instrumentation and Controls (I&C)...

  • Electronics and Controls Specialist

    4 weeks ago

    Carlsbad, New Mexico, United States Salado Isolation Mining Contractors Full time

    Job Summary:Salado Isolation Mining Contractors is seeking a skilled Electronics and Controls Specialist to join our team at the Waste Isolation Pilot Plant (WIPP) in Carlsbad, NM. As an Instrumentation and Control Systems Technician, you will be responsible for performing a wide range of tasks related to electronics, calibration, and instrumentation and...

  • Scientific Quality Control Specialist

    4 weeks ago

    Carlsbad, California, United States Yoh Full time

    Scientist (Level I) Quality Control Job DescriptionYoh is actively recruiting for a Scientist (Level I) Quality Control contract assignment. This role involves working in a collaborative team environment and playing a critical role in performing Quality Control assays and experiments on molecular biology reagents for global use in research and commercial...

  • Pest Control Specialist

    1 month ago

    Carlsbad, New Mexico, United States Orkin Full time

    About OrkinOrkin is a global residential and business service provider that offers comprehensive and efficient pest management services. With over 120 years of experience, we have established ourselves as a leader in the industry.Job SummaryWe are seeking a highly motivated and detail-oriented Pest Control Technician to join our team. As an Orkin Pro, you...

  • Quality Control Technician

    2 months ago

    Carlsbad, United States Bolt Medical Full time

    DIRECT CANDIDATES ONLY, IF INTERESTED APPLY THROUGH JOB POST. NO DIRECT MESSAGES.RECRUITERS: DO NOT CONTACT.Role DescriptionThe Quality Inspector performs incoming inspection, in-process inspections, and final inspections of components and assemblies per control/quality plans. The Quality Inspector will review and approve final release documentation....

  • Graphic Quality Assurance Specialist

    2 weeks ago

    Carlsbad, United States The Upper Deck Company Full time

    Job OverviewUpper Deck, a worldwide sports and entertainment company, seeks a skilled Graphic Quality Assurance Specialist to ensure the highest quality of digital files and prints.The ideal candidate will have a strong understanding of prepress production, quality control, and attention to detail.Review digital files, proofs, and overlays to ensure content...

  • Senior Automation Controls Engineer

    4 weeks ago

    Carlsbad, United States Dennis Group San Diego Full time

    Job SummaryAs a design build engineering firm and general contractor that designs and builds food and beverage processing facilities, Dennis Group's automation & controls engineers work closely with our process, packaging and building engineers to meet our clients' expectations in startup, commissioning, and qualifying their food and beverage production...

  • Digital Radiography Specialist

    4 weeks ago

    Carlsbad, New Mexico, United States NONDESTRUCTIVE & VISUAL INSPECTION Full time

    Job SummaryWe are seeking a highly skilled Digital Radiography Specialist to join our team at NONDESTRUCTIVE & VISUAL INSPECTION. As a Digital Radiography Specialist, you will be responsible for performing Level II DR profile inspections and other NDE inspections as specified with the Company's procedures.Key ResponsibilitiesOperate and maintain Digital...

  • Digital Radiography Specialist

    4 weeks ago

    Carlsbad, New Mexico, United States NONDESTRUCTIVE & VISUAL INSPECTION Full time

    Job SummaryNONDESTRUCTIVE & VISUAL INSPECTION is seeking a skilled Digital Radiography Specialist to join our team. As a Digital Radiography Specialist, you will be responsible for performing Level II DR profile inspections and other NDE inspections as specified with the Company's procedures. You will also operate and maintain Digital Radiography equipment,...

  • Labeling and Database Specialist

    1 month ago

    Carlsbad, United States Adecco USA Full time

    We are seeking a skilled Labeling and Database Specialist to support the creation, maintenance, and implementation of product labeling. This role is crucial for managing new and updated labeling specifications and involves submitting and publishing data to the Global Unique Device Identification Database and the European Database on Medical Devices.Key...

  • Database Specialist

    4 weeks ago

    Carlsbad, United States Marquee Staffing - CB Full time

    Job Title: Database SpecialistJob Summary:We are seeking a highly skilled Database Specialist to join our team at Marquee Staffing - CB. As a key member of our team, you will be responsible for supporting the creation, maintenance, and implementation of product labeling, including the management of new and updated labeling specifications.Key...

  • Radiographic Testing Specialist

    4 weeks ago

    Carlsbad, New Mexico, United States NONDESTRUCTIVE & VISUAL INSPECTION Full time

    Job DetailsJob Title: Radiographic Testing SpecialistJob Location: Carlsbad, NMPosition Type: Full TimeJob Shift: AnyJob Category: QA - Quality ControlDescriptionNVI, LLC is seeking a highly motivated and career-minded Radiographic Testing Specialist to fill an immediate opening within our Odessa, TX Division. As a member of our team, you will have access to...

  • Senior Manufacturing Quality Control Engineer

    2 months ago

    Carlsbad, United States American Lithium Energy Corporation Full time

    Role Description• This is a full-time on-site role for a Senior Manufacturing Quality Control Engineer at the American Lithium Energy Corporation in Carlsbad, CA. The Senior Manufacturing Quality Control Engineer will be responsible for overseeing quality control processes, conducting inspections, identifying defects, and implementing corrective actions to...

  • Quality Control Scientist

    3 weeks ago

    Carlsbad, United States Indotronix Avani Group Full time

    Title: Scientist II, Quality ControlLocation: Carlsbad, CA 92008Duration: 9 MonthsPay: $30 - $32 ph. MaxHow will you make an impact?As a Scientist, you will have the opportunity to work in a collaborative team and will play a critical role in performing Quality Control assays and experiments on molecular biology reagents for global use in research and...

  • Design Specialist

    1 month ago

    Carlsbad, California, United States Carlsmed Full time

    Job OverviewCarlsmed is seeking a talented Design Associate to contribute to the development of proprietary implants, instrumentation, and design automation systems for personalized surgery.Key Responsibilities:Analyze patient CT data to inform design decisionsCollaborate with engineers, designers, and clinical specialists to complete designsCreate surface...