Talent.com
Quality Assurance Document Controller
Quality Assurance Document ControllerMedasource • Durham, NC, US
[error_messages.no_longer_accepting]
Quality Assurance Document Controller

Quality Assurance Document Controller

Medasource • Durham, NC, US
[job_card.variable_days_ago]
[job_preview.job_type]
  • [job_card.temporary]
[job_card.job_description]

QA Document Controller

Duration : 18 month contract with probability of extensions or conversion

Schedule : M-F, 8-5 plus adhoc off hours / weekend support per business needs

Location

Durham, NC

Description :

The Document Controller supports document management for the issuance, distribution, reconciliation, labeling, and filing of GMP documentation for the Client Library Site. This role ensures compliance with Client GMP document requirements and supports the full scope of Library Support Services as defined by site management.

Key Responsibilities :

Record Management

  • Maintain Client Library Site document inventory control through the Record Manager (LRM) system in accordance with applicable SOPs.
  • Ensure accurate control and tracking of all GMP documents.

Document Control

  • Perform document control activities for all Client Site documents and records maintained in Client's Veeva Quality Docs Electronic Data Management System (EDMS).

    • Training

  • Complete all required Client training and maintain compliance with documentation and records management procedures.

    • Route & Distribute Documents

  • Assist with routing, updating, and approval of electronic documents according to applicable SOPs and Client personnel requirements.

    • Veeva Workflow Oversight

  • Manage and monitor assigned Veeva Vault Quality Docs workflows daily.

    • Review Documents & Update Metadata

  • Meet with internal personnel as needed to review documents and update Veeva Quality Docs metadata when adding documents into the system.

    • Records Retention

  • Manage retention of GMP records in accordance with document type, record class codes, and Client retention policies.
  • Prepare and manage shipment of records to off-site storage for long-term retention when required.

    • Reconciliation

  • Facilitate the reconciliation process for executable electronic and paper records according to applicable SOPs.

    • Maintain Signature Logs

  • Oversee and complete annual department signature logs.

    • Logbook Creation & Issuance

  • Bind, issue, and maintain physical logbooks; support reconciliation of paper logbooks per SOP requirements.

    • Labeling & Coding

  • Label and code files for storage in on-site Documentation Centers.

    • Audit Support

  • Support internal and external audits by providing readily accessible records.
  • Assist with additional staffing or extended hours if requested in relation to audits, in alignment with Work Order terms.

    • Site Self-Inspection Support

  • Support self-inspections by ensuring documentation and records are compliant and accessible within Veeva Vault EDMS.

    • Document Periodic Reviews

  • Monitor and conduct periodic document reviews per SOPs and management direction.

    • Library Document Support

  • Work closely with Quality, Learning and Development, and other site business areas to capture and support document needs.
  • Periodically update documents in accordance with applicable SOPs.

    • Issue Escalation

  • Escalate issues to contractor leads or Client management as appropriate.

    • SOP Compliance

  • Follow all applicable Client GMP Standard Operating Procedures and report any compliance concerns in a timely manner.

    • Qualifications

  • BA / BS degree or equivalent experience
  • 1–3 years of relevant experience in the pharmaceutical / biopharmaceutical industry (preferred)
  • General understanding of basic GDP principles and GMP environments
  • Strong proficiency with Microsoft Office applications
  • Familiarity with office equipment (copier, scanner, fax, etc.)
  • Proficient with Document Routing System workflow functionality
  • Ability to climb stairs, bend, and reach for filing; lift up to 30 lbs. as needed to move / organize file boxes
    • [job_alerts.create_a_job]

    Quality Assurance • Durham, NC, US

    [internal_linking.similar_jobs]
    Travel Mammography Tech - $2,515 per week in Roxboro, NC

    Travel Mammography Tech - $2,515 per week in Roxboro, NC

    AlliedTravelCareers • Roxboro, NC, US
    [job_card.full_time]
    Windsor Healthcare Recruitment Group, Inc.AlliedTravelCareers is working with Windsor Healthcare Recruitment Group, Inc.Mammography Tech in Roxboro, North Carolina, 27573!.Orientation is weekly, on...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Quality Assurance & Regulatory Specialist

    Quality Assurance & Regulatory Specialist

    InsideHigherEd • Chapel Hill, North Carolina, United States
    [job_card.full_time] +2
    Quality Assurance & Regulatory Specialist.A global higher education leader in innovative teaching, research and public service, the. University of North Carolina at Chapel Hill.Known for its beautif...[show_more]
    [last_updated.last_updated_1_day] • [promoted]
    Manager, Technical Compliance and Data Integrity Lead

    Manager, Technical Compliance and Data Integrity Lead

    Novartis AG • Durham, NC, United States
    [job_card.full_time]
    Summary The Manager, Technical Compliance, is responsible to support the DI Lead at Gene Therapies North Carolina Site on the Data Integrity Program and support the quality risk management program...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Doctor of Optometry

    Doctor of Optometry

    Patty Vision Center of Roxboro • Roxboro, North Carolina, United States
    [job_card.full_time] +1
    Exciting opportunity at a growing multi-location practice with a strong patient-centered focus located just north of Durham on a part time (1-3 days a week) or a full time basis.This is a great job...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Travel Nurse RN - ED - Emergency Department - $2,105 per week

    Travel Nurse RN - ED - Emergency Department - $2,105 per week

    LifePoint • Roxboro, NC, USA
    [job_card.full_time]
    LifePoint is seeking a travel nurse RN ED - Emergency Department for a travel nursing job in Roxboro, North Carolina.Job Description & Requirements.[show_more]
    [last_updated.last_updated_30] • [promoted]
    Director, Payment Integrity - Coordination of Benefits and Data Mining

    Director, Payment Integrity - Coordination of Benefits and Data Mining

    Blue Cross and Blue Shield of North Carolina • Chapel Hill, NC, United States
    [job_card.full_time]
    Direct, manage and lead highly complex functional and / or broad foundational business areas within Payment Integrity to define and enable strategic and operational priorities.Lead and set goals for ...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Travel Nurse - ED - Emergency Department Job in Roxboro, NC - $8,018 per Month (2 Years Experience Needed)

    Travel Nurse - ED - Emergency Department Job in Roxboro, NC - $8,018 per Month (2 Years Experience Needed)

    Vetted Health • Roxboro, NC, United States
    [job_card.full_time]
    RN - ED - Emergency Department.Must have 2+ years of experience.This contract pays approximately $8,018 / month gross.Guaranteed Pay : Never worry about canceled shifts. Premium Overtime : 2x hourly rat...[show_more]
    [last_updated.last_updated_variable_hours] • [promoted] • [new]
    Medical Coder II- Physician Rev Cycle Coding

    Medical Coder II- Physician Rev Cycle Coding

    UNC Health Care Systems • Chapel Hill, NC, United States
    [job_card.full_time]
    Description 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 : Performs technic...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Travel Nurse RN - Long-Term Care - $1,900 to $2,100 per week in Roxboro, NC

    Travel Nurse RN - Long-Term Care - $1,900 to $2,100 per week in Roxboro, NC

    TravelNurseSource • Roxboro, NC, US
    [job_card.full_time]
    Registered Nurse (RN) | Long-Term Care.TravelNurseSource is working with Titan Medical Group to find a qualified Long-Term Care RN in Roxboro, North Carolina, 27573!. Titan Medical is looking for tr...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Registered Nurse (ICU) Full Time

    Registered Nurse (ICU) Full Time

    LifePoint Health • Roxboro, NC, USA
    [job_card.full_time]
    Job Type : Full-Time | Night Weekends.Up to $20,000 in Commitment Bonus).At Person Memorial Hospital, we are driven by a profound commitment to prioritize your well-being so you can provide exceptio...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Document Control Coordinator I

    Document Control Coordinator I

    Zachry Group • Roxboro, NC, United States
    [job_card.full_time]
    Zachry Group values meaningful contributions and shared success.We welcome your application to be considered for.Join our pipeline of mission-driven professionals making a lasting impact through co...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Senior Project Manager-Medical Device

    Senior Project Manager-Medical Device

    Gilero, A Sanner Group Company • Durham, NC, US
    [job_card.full_time]
    Are you a seasoned Project Manager with a passion for bringing innovative medical and drug delivery devices to life? At Gilero’s Durham's. In this role, you’ll drive complex projects...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Quality Assurance Document Controller

    Quality Assurance Document Controller

    Medasource • Durham, NC, United States
    [job_card.temporary]
    M-F, 8-5 plus adhoc off hours / weekend support per business needs.The Document Controller supports document management for the issuance, distribution, reconciliation, labeling, and filing of GMP d...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Travel Emergency Room Registered Nurse

    Travel Emergency Room Registered Nurse

    LRS Healthcare - Travel Nursing • Roxboro, NC, US
    [job_card.permanent]
    LRS Healthcare - Travel Nursing is seeking a travel nurse RN ED - Emergency Department for a travel nursing job in Roxboro, North Carolina. Job Description & Requirements.LRS Healthcare - Travel...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Quality Assurance I (Intern) - United States

    Quality Assurance I (Intern) - United States

    Cisco Systems, Inc. • Research Triangle Park, NC, United States
    [job_card.full_time]
    Please note this posting is to advertise potential job opportunities.This exact role may not be open today but could open in the near future. When you apply, a Cisco representative may contact you d...[show_more]
    [last_updated.last_updated_30] • [promoted]
    Analyst 3 – Credit & Collection

    Analyst 3 – Credit & Collection

    A-Line Staffing Solutions LLC • Durham, NC, US
    [job_card.full_time]
    Title : Analyst 3 – Credit & Collection.Note : This position is a contract on W2, and is NOT open to C2C.We are seeking a motivated and detail-oriented Credit & Collection Specialist for a temp to hi...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Government Contract Compliance Manager

    Government Contract Compliance Manager

    ABB LTD • NC, United States
    [job_card.full_time]
    At ABB, we help industries outrun - leaner and cleaner.Here, progress is an expectation - for you, your team, and the world. As a global market leader, we'll give you what you need to make it happen...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]
    Manager Project Controls

    Manager Project Controls

    Matrix Service Company • Rougemont, NC, United States
    [job_card.full_time]
    The Site Based Project Controls Manager is responsible for the development, execution, and supervision of the Cost Control, Progress and Performance (Earned Value), Project Scheduling, and assigned...[show_more]
    [last_updated.last_updated_variable_days] • [promoted]