Job Title : QA Associate Specialist Document Control
Location : Bothell, WA
Duration : 12 months (Possibility of extension)
Position Type : Hourly contract Position (W2 only)
5 + years of with Library science, Document scanning exp, FDA Documentation and compliance!(21 CFR part 11 CGMP) (Adobe, Visio)
Job Description : PURPOSE AND SCOPE OF POSITION :
The Quality Assurance Document Control (QADC) Associate Specialist supports the cGMP Document Control operations for Client Jump site records management.
Responsibilities include but are not limited to receiving and reconciliation of GMP records, management of scanning, archival and retention of GMP records.
Education : Bachelor’s degree or equivalent. Library Science a plus
Experience Basic Qualifications :
Minimum of 5 - 8 years of relevant document control records management experience in a cGMP / FDA regulated environment
Experience with Part 11 adherence regarding scanning of records and electronic archiving.
Strong knowledge of cGMPs and domestic regulatory requirements
DUTIES AND RESPONSIBILITIES :
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
Thorough Knowledge of Records Management, Scanning and organization functions
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.
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