QA Document Control Associate

Job Details

  • ID#37941663
  • Address 98021 , Bothell,

    Washington

    Bothell USA
  • Job type

    Contract

  • Salary USD $57.74 hr 57.74 hr
  • Hiring Company

    Alpha Consulting Corp.

  • Showed05th April 2022
  • Date04th April 20222022-04-04T00:00:00-0700
  • Deadline03rd June 2022
  • Category

    Science/biotech

QA Document Control Associate

Vacancy expired!

QA DOCUMENT CONTROL ASSOCIATE BOTHELL, WA Required Skills:

  • Bachelor's degree or equivalent.
  • Minimum of 1 year of relevant document control management experience in a cGMP/FDA regulated environment.
  • Strong communication and customer service skills.
  • Some technical writing skill set and be able to critically review documents while effectively inputting and expressing Quality principles.
  • Strong computer skills with MS Office (e.g., Word, Adobe, Visio, and Excel) and with Quality Systems (e.g., Document Management System, Quality Management System).
  • Must demonstrate the following behaviors consistently - Innovative, proactive, and resourceful, committed to quality and continuous improvement.
  • Able to prioritize, manage time well, multi-task, and troubleshoot effectively.
  • Ability to work effectively and collaboratively at a fast pace with cross functional departments to finalize time-sensitive deliverables.
  • Possess project management skills.
  • Strong knowledge of cGMPs and domestic regulatory requirements.
  • Knowledge of manufacturing quality (manufacturing, packaging, facilities, critical systems, validation, etc.).
  • Must complete tasks independently, notify manager of decisions outside of established processes and the ability to build an internal network.
  • Some labeling experience strongly preferred.
  • Experience interacting with FDA or other regulatory agencies strongly preferred.
Project Description:
  • Issuing production batch records, labels, and other controlled documents to support manufacturing operations.
  • Responsible for the organization of cGXP controlled document files within the Document Center and ensure that records are readily retrievable and sent off to final archive facility as needed.
  • Assist with managing the Document Center Archive room.
  • Managing an electronic document system for the JuMP site which includes reviewing and approving document change requests, troubleshooting and releasing documents to an effective state.
  • May write and revise document control procedures including participating in the development and roll-out of document control tools.
  • Follow Policies, SOPs, and work instructions to support the document approval process, assign effective dates and training workflows, and archive documents and document change requests.
  • Assist with cross-training of Document Control personnel and customers to ensure adherence with procedures.
  • Execute the process and procedures for identifying, collecting, distributing, and filing the controlled documents for the site.
  • Support internal and external audits and regulatory inspections.
  • This may require data gathering, interviewing, or escorting auditors during the audit.
  • Assist with document retrieval /organization support during regulatory inspections.
  • Perform Document Control metric reporting and analysis for the local site data.
  • This may require the use of relational databases and reporting tools to collate and analyze quality data.
  • Provide communication as to the status of Quality Systems deliverables to customers, management, and stakeholders.
  • Weekend and off-shift support may be required.
This 12+ month position starts ASAP. Please E-MAIL your resume (attachment to email) with rate and availability to Cheryl: ALPHA'S REQUIREMENT #22-01006 MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE

Vacancy expired!