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QA Documentation Specialist - II

In California / United States

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QA Documentation Specialist - II   

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JOB TITLE:

QA Documentation Specialist - II

JOB TYPE:

JOB SKILLS:

JOB LOCATION:

Foster City (US001 California / United States

JOB DESCRIPTION:

Description:

Documentation Specialist II

Required to come in the office at a minimum of 3 days per week ( Flexible schedule )
Required to take COVID 19 Test 2-10 days prior to assignment, and take a test from Gilead onsite or home every 2 weeks

Responsibilities:

Ensures accuracy of paper record inventory on-site and off-site, e.g., binders stored on-site, wet-signed paper Original Records (executed forms and protocols) awaiting off-site archival and/or already being stored in off-site storage facility.
Accepts receipt of paper records submitted for archival.
Verifies the consistent application of Good Documentation Practices (GDP) in received paper records.
Completes data entry of received paper records in records management system.
Scans paper records, verifies completeness of electronic copies, and uploads electronic copies into Electronic Document Management System (EDMS), e.g., true copy certification process.
Oversees the process for off-site archival of paper records, including filling vendor storage boxes, scheduling vendor pickup and record retrieval.
Continuously updates records management system to track the status of a paper record in the archival process.
Supports periodic audit of archived paper records.
Works on assignments that are moderately complex in nature where ability to recognize deviation from accepted practice is required.
Identifies deviations from document control procedures. Notifies IT management and assists with issue resolution.
Provides paper record archival process metrics for management review.
Provides support for internal and regulatory audits/inspections as required.
As needed, provides support for processing of electronic documentation in EDMS

Knowledge, Experience and Skills:
Demonstrates strong working knowledge of, and has extensive relevant experience with, managing paper records, including true electronic copy creation, archiving originals in off-site storage, and use of a records management system, such as FileTrail or similar (in a GxP environment is preferred).
Demonstrates strong verbal, technical writing, and interpersonal skills.
Demonstrates strong working knowledge of Document Control fundamentals, Quality Systems, and GxP requirements.
Demonstrates strong working knowledge of Electronic Document Management Systems (EDMS), such as VeevaVault Quality Docs or similar (in a GxP environment is preferred), including relevant experience with managing and troubleshooting review/approval/obsoletion/retirement workflows and document classification/metadata.
Demonstrates effective organizational, planning, and time management skills.
Demonstrates high attention to detail, while service-oriented, with the ability to process high volumes of requests/paper record submissions and archival in a timely, prioritized and compliant manner.
Demonstrates strong computer skills with software used in document processing, which includes MS Excel, Word, Client Acrobat.
3+ years of relevant experience in a regulated industry. Direct experience with documentation management in a GxP pharmaceutical setting is preferred, including extensive experience with GDP.

Position Details

POSTED:

Aug 21, 2021

EMPLOYMENT:

INDUSTRY:

SNAPRECRUIT ID:

S16204864942713480

LOCATION:

California / United States

CITY:

Foster City (US001

Job Origin:

CEIPAL_ORGANIC_FEED

A job sourcing event
In Dallas Fort Worth
Aug 19, 2017 9am-6pm
All job seekers welcome!

QA Documentation Specialist - II    Apply

Click on the below icons to share this job to Linkedin, Twitter!

Description:

Documentation Specialist II

Required to come in the office at a minimum of 3 days per week ( Flexible schedule )
Required to take COVID 19 Test 2-10 days prior to assignment, and take a test from Gilead onsite or home every 2 weeks

Responsibilities:

Ensures accuracy of paper record inventory on-site and off-site, e.g., binders stored on-site, wet-signed paper Original Records (executed forms and protocols) awaiting off-site archival and/or already being stored in off-site storage facility.
Accepts receipt of paper records submitted for archival.
Verifies the consistent application of Good Documentation Practices (GDP) in received paper records.
Completes data entry of received paper records in records management system.
Scans paper records, verifies completeness of electronic copies, and uploads electronic copies into Electronic Document Management System (EDMS), e.g., true copy certification process.
Oversees the process for off-site archival of paper records, including filling vendor storage boxes, scheduling vendor pickup and record retrieval.
Continuously updates records management system to track the status of a paper record in the archival process.
Supports periodic audit of archived paper records.
Works on assignments that are moderately complex in nature where ability to recognize deviation from accepted practice is required.
Identifies deviations from document control procedures. Notifies IT management and assists with issue resolution.
Provides paper record archival process metrics for management review.
Provides support for internal and regulatory audits/inspections as required.
As needed, provides support for processing of electronic documentation in EDMS

Knowledge, Experience and Skills:
Demonstrates strong working knowledge of, and has extensive relevant experience with, managing paper records, including true electronic copy creation, archiving originals in off-site storage, and use of a records management system, such as FileTrail or similar (in a GxP environment is preferred).
Demonstrates strong verbal, technical writing, and interpersonal skills.
Demonstrates strong working knowledge of Document Control fundamentals, Quality Systems, and GxP requirements.
Demonstrates strong working knowledge of Electronic Document Management Systems (EDMS), such as VeevaVault Quality Docs or similar (in a GxP environment is preferred), including relevant experience with managing and troubleshooting review/approval/obsoletion/retirement workflows and document classification/metadata.
Demonstrates effective organizational, planning, and time management skills.
Demonstrates high attention to detail, while service-oriented, with the ability to process high volumes of requests/paper record submissions and archival in a timely, prioritized and compliant manner.
Demonstrates strong computer skills with software used in document processing, which includes MS Excel, Word, Client Acrobat.
3+ years of relevant experience in a regulated industry. Direct experience with documentation management in a GxP pharmaceutical setting is preferred, including extensive experience with GDP.


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