Talent.com
Technical Documentation Specialist

Technical Documentation Specialist

BelcanGreensboro, NC, United States
2 days ago
Job type
  • Full-time
Job description

Job Title : Technical Documentation Specialist (Engineering-Process Technologies )

Location : Greensboro, NC

Zip Code : 27409

Duration : 2 Months

Responsibilities :

  • "Organizing an archiving system.
  • Labelling, sorting, and categorizing documents for ease of use.
  • Retrieving documents upon request.
  • Outlining a long-term storage strategy.
  • Adhering to regulatory requirements.
  • Working with colleagues to ensure consistency of documentation practice across the company.
  • Assisting with both internal and external audits.
  • Ensuring documentation integrity.
  • Controlling access to documents.
  • Removing documents that are obsolete.
  • Utilizing storage software and applications for electronic filing.
  • Performing transcription and conversion work.
  • Proofreading documents upon request.

Nice To Have :

  • Execute with Excellence - Previous role experience within Initiative Leadership, Project Management, Marketing Specialist, or Work Process Ownership. Demonstration and Implementation of work processes, workflows, working with Multifunctional Resources / Teams. Acts as a business owner with great sense of urgency and focus to manage multiple projects / priorities with the organization and attention to detail. High Capacity to lead multiple projects at any given period.
  • Lead with Courage - Ability to demonstrate Leadership to set direction / priority for others, hold others accountable to deadlines, develop execution plans, and work collectively across functions and suppliers. Can manage expectations and engagement across all business functions.
  • Embraces Change - Is open and flexible / adaptable to change by seeking out and readily accepting new ideas, experiences, skills, opportunities, and new work processes.
  • Excellent Communications / Collaboration skills to lead meetings, listening to feedback / input to put into clear actions, written updates to Initiative teams / leadership, peers and escalate help requests / issues. Strong Collaboration with internal and external partners.
  • Strong Problem-solving skills to quickly identify and resolve issues to root cause, access risk and determine approach / next steps to mitigate.
  • Champion Productivity- Demonstration of skills / experience to analyze data for utilization in results reporting (written / oral), gap analysis, loss analysis and work process improvement. Is capable to demonstrate mastery within Microsoft Word, Excel, Powerpoint and Office 365 Tools. Skills Needed : Leadership, Embraces Change / Agile, Collaborative, Develops Others, Operates with Discipline, Business Mastery, Technical Mastery.
  • Authoring and editing / revising Validation Documents (Protocols, Reports, etc.) for Validation Activities (EOs, PPQs, etc.).
  • Must Have :

  • Authoring and editing / revising Validation Documents (Protocols, Reports, etc.) for Validation Activities (EOs, PPQs, etc.).
  • Experience in cGMP documentation review required Experience in highly regulatory business with ANDA and regulatory requirements
  • Facilitating Review & Approval of Validation Documents in formal Document Management Systems.
  • On-site support to execute Validation Activities in the packaging operations at the GBO PHC plant.
  • Reviewing and providing mark-up / input on Validation Documents authored by others.
  • GMP (Good Manufacturing Practices) Compliance
  • GDP (Good Documentation Practices)
  • QMS (Quality Management Systems)
  • FDA 21 CFR Part 210, 211, 820 Regulations
  • Batch Record Review & Approval
  • CAPA (Corrective and Preventive Actions)
  • Investigation & Deviation Management
  • Change Control Management
  • Quality Systems Auditing (Internal / External)
  • Pre-Approval Inspection (PAI) Preparedness
  • Aseptic Processing & Sterile Drug Products
  • Document Control & SOP Review
  • Training Program Development & Delivery
  • On-the-Job Training (OJT) & Curriculum Development
  • Regulatory Compliance & Inspection Readiness
  • Data Integrity & LIMS
  • Root Cause Analysis & Problem Solving
  • Customer Complaint Investigation
  • Project Management & Continuous Improvement
  • TrackWise, Veeva Vault, Documentum, QUMAS
  • MS Visio, MS PowerPoint, Excel, Word, Smartsheet
  • Create a job alert for this search

    Documentation Specialist • Greensboro, NC, United States

    Related jobs
    • Promoted
    Local Contract MRI Technologist - $53-57 per hour

    Local Contract MRI Technologist - $53-57 per hour

    Host HealthcareHigh Point, NC, United States
    Full-time
    Host Healthcare is seeking a local contract MRI Technologist for a local contract job in High Point, North Carolina.Job Description & Requirements. Host Healthcare Job ID #La1fVJ000007CKdFYAW.Pay pa...Show moreLast updated: 30+ days ago
    • Promoted
    Patient Access ED Registration Specialist

    Patient Access ED Registration Specialist

    Cone HealthReidsville, NC, United States
    Full-time
    The Patient Access ED Registration Specialist is the first point of contact and creates a welcoming environment to include anticipation and action on the needs of our internal and external customer...Show moreLast updated: 30+ days ago
    • Promoted
    Travel MRI Technologist

    Travel MRI Technologist

    LanceSoftEden, NC, US
    Permanent
    LanceSoft is seeking a travel MRI Technologist for a travel job in Eden, North Carolina.Job Description & Requirements.F3AF. Why LanceSoft? .We’re proud to be recognized by St...Show moreLast updated: 30+ days ago
    • Promoted
    Maintenance Tech Specialist

    Maintenance Tech Specialist

    Federal Express CorporationKernersville, NC, United States
    Full-time
    The Maintenance Technician Specialist supports the FedEx Industrial maintenance of material handling through the application and demonstration of highly advanced knowledge and skills in all discipl...Show moreLast updated: 6 days ago
    • Promoted
    Communication Specialist

    Communication Specialist

    Cone HealthGreensboro, NC, United States
    Full-time
    The Communication Specialist assists with facilitating communications across the system in order to ensures immediate response and efficient coordination other system teams.Working under close supe...Show moreLast updated: 30+ days ago
    • Promoted
    Senior Manager, FAA- Certification

    Senior Manager, FAA- Certification

    Honda Aero, LLC.Burlington, NC, US
    Full-time
    What Makes a Honda, is Who makes a Honda.Honda has a clear vision for the future, and it’s a joyful one.We are looking for individuals with the skills, courage, persistence, and dreams t...Show moreLast updated: 30+ days ago
    • Promoted
    Interpreter - Interpreter Services

    Interpreter - Interpreter Services

    UNC Health CareSiler City, NC, United States
    Full-time
    Become part of an inclusive organization with over 40,000 teammates, whose mission is to improve the health and well-being of the unique communities we serve. Summary : Provides translation-interprete...Show moreLast updated: 30+ days ago
    • Promoted
    HSPD-12 : Government Badging & Credentialing Specialist (Greensboro, NC- REF1809O) • •

    HSPD-12 : Government Badging & Credentialing Specialist (Greensboro, NC- REF1809O) • •

    CitizantGreensboro, NC, United States
    Full-time
    Citizant is a leading provider of professional IT services to the U.We seek to address some of our country's most pressing challenges in the areas of Agile application development, Enterprise Data ...Show moreLast updated: 30+ days ago
    • Promoted
    Clinical Support Tech I ICU

    Clinical Support Tech I ICU

    UNC Health CareEden, NC, United States
    Full-time
    Become part of an inclusive organization with over 40,000 teammates, whose mission is to improve the health and well-being of the unique communities we serve. Responsible for assisting the professio...Show moreLast updated: 10 days ago
    • Promoted
    Patient Access Intake Specialist-Chatham Hospital

    Patient Access Intake Specialist-Chatham Hospital

    UNC Health CareSiler City, NC, United States
    Full-time
    Become part of an inclusive organization with over 40,000 teammates, whose mission is to improve the health and well-being of the unique communities we serve. This position will be Monday-Friday fro...Show moreLast updated: 10 days ago
    • Promoted
    Supplier QA Specialist (Food)

    Supplier QA Specialist (Food)

    Atrium StaffingArchdale, NC, US
    Full-time
    As a people-centric organization, we foster an environment of collaboration, high performance, and innovation where your talents are valued and your achievements are celebrated.Join us and become p...Show moreLast updated: 18 days ago
    • Promoted
    Travel CT Tech - $2,206 per week in Reidsville, NC

    Travel CT Tech - $2,206 per week in Reidsville, NC

    AlliedTravelCareersReidsville, NC, US
    Full-time +1
    AlliedTravelCareers is working with Lancesoft Inc.CT Tech in Reidsville, North Carolina, 27320!.Perform diverse CT procedures, including advanced imaging and low dose protocols.Manage IVs, power in...Show moreLast updated: 6 days ago
    • Promoted
    Housing Specialist - Back @ Home (Central NC)

    Housing Specialist - Back @ Home (Central NC)

    Vaya HealthYanceyville, NC, United States
    Permanent
    Remote - must live in or near Alamance, Caswell, Person, Chatham, Granville, Vance, Franklin, or Rockingham, North Carolina. This position will serve these counties.Incumbent in this role must be a ...Show moreLast updated: 14 days ago
    • Promoted
    Patient Access Intake Specialist

    Patient Access Intake Specialist

    UNC Health CareSiler City, NC, United States
    Full-time
    Become part of an inclusive organization with over 40,000 teammates, whose mission is to improve the health and well-being of the unique communities we serve. This position will be at Chatham ED Reg...Show moreLast updated: 30+ days ago
    • Promoted
    Technical Documentation Specialist (Greensboro)

    Technical Documentation Specialist (Greensboro)

    BelcanGreensboro, NC, US
    Part-time
    Job Title : Technical Documentation Specialist (Engineering-Process Technologies ).Organizing an archiving system.Labelling, sorting, and categorizing documents for ease of use.Retrieving documents ...Show moreLast updated: 2 days ago
    • Promoted
    Patient Access Intake Specialist-Pittsboro

    Patient Access Intake Specialist-Pittsboro

    UNC Health CareSiler City, NC, United States
    Full-time
    Become part of an inclusive organization with over 40,000 teammates, whose mission is to improve the health and well-being of the unique communities we serve. This position will be Monday-Friday fro...Show moreLast updated: 10 days ago
    • Promoted
    CT Technologist

    CT Technologist

    UNC Health CareEden, NC, United States
    Full-time
    Become part of an inclusive organization with over 40,000 diverse employees, whose mission is to improve the health and well-being of the unique communities we serve. Conducts procedures and tests u...Show moreLast updated: 30+ days ago
    • Promoted
    Interpreter

    Interpreter

    UNC Health CareSiler City, NC, United States
    Full-time
    Become part of an inclusive organization with over 40,000 teammates, whose mission is to improve the health and well-being of the unique communities we serve. Summary : Provides translation-interprete...Show moreLast updated: 30+ days ago