Job Posting for Document Control Specialist at LanceSoft, Inc.
Job Title: Quality Assurance Document Control (QADC) Associate Specialist
Location: Bothell, WA 98021
Duration: 6 Months
Shift- Sunday - Thursday 10:00pm - 6:30am
Top Skills:
Strong communication and customer service skills.
Innovation
Able to prioritize, manage time well, multi-task, and troubleshoot effectively
Smartsheet and Excel experience
Ability to provide examples on how they have honed in on attention to detail
Review of SOPs, procedures, edits and annotations within EDMS experience
Job Description:
The Quality Assurance Document Control (QADC) Associate Specialist supports the cGMP Document Control operations for the Client Jump site, including the document change control process, issuance and reconciliation of batch records, batch related forms, product labels, and management of archival and retention of GMP records.
Education: Bachelor’s degree or equivalent
Experience Basic Qualifications:
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.
Experience interacting with FDA or other regulatory agencies strongly preferred
Strong knowledge of cGMPs and domestic regulatory requirements
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