Fate Therapeutics Inc.
Document Control Associate
Fate Therapeutics Inc., San Diego, California, United States, 92189
Document Control Associate at Fate Therapeutics Inc. This is a full-time, non-exempt position located at our corporate headquarters in San Diego, CA.
Responsibilities
Day-to-day management of the Document Control program, including, but not limited to:
Issuance of batch records, labels, logbooks, and other controlled documents as needed.
Document change control review and assessment.
Management of all paper & electronic records, including filing, scanning, and offsite storage.
Assist with the daily management of the eDMS (Veeva Vault QualityDocs).
Document periodic review process.
Write, revise, and review documents such as Standard Operating Procedures (SOPs) and Work Instructions relating to QA/Document Control.
Proactively maintain an understanding of regulations and best practices for a robust Quality Management System e.g., FDA, USP, ICH, etc.
Support and take ownership in Quality Events related to Document Control, such as CAPAs, Deviations, Change controls, and Audit actions.
Responsible for tracking and reporting department metrics.
Maintain Quality tracking systems for controlled documents and data.
Assess effectiveness of current Document Control processes and implement improvements.
Provide training on document control and document change processes as needed.
Qualifications
M.S. or B.S. degree with minimum 3+ years prior hands-on experience with Document Control in the biotechnology or pharmaceutical industry that includes work on early-stage products. GED or high school degree with 4+ years of relevant experience may be considered.
Excellent organizational skills with a professional demeanor and the ability to work well in a team environment with cross-functional team members.
Experience preparing and reviewing cGMP documentation in support of manufacturing operations.
Working knowledge of 21 CFR Part 211 and 210, FDA/ICH guidelines, and industry/technology standard practices including GMP, GCP, and GTP.
Excellent writing skills and proficiency with MS Office applications, particularly Word and Excel.
Strong attention to detail and communication skills.
Able to work independently and prioritize tasks in a fast paced and dynamic environment.
Able to independently address issues of low to moderate complexity.
Working Conditions
On-call support may be required.
Subject to extended periods of sitting and standing, vision to monitor, and moderate noise levels.
$34 - $42 an hour
Equal Employment Opportunity Fate Therapeutics, Inc. is an equal opportunity employer. We value diversity and are committed to creating an inclusive environment for all employees.
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Responsibilities
Day-to-day management of the Document Control program, including, but not limited to:
Issuance of batch records, labels, logbooks, and other controlled documents as needed.
Document change control review and assessment.
Management of all paper & electronic records, including filing, scanning, and offsite storage.
Assist with the daily management of the eDMS (Veeva Vault QualityDocs).
Document periodic review process.
Write, revise, and review documents such as Standard Operating Procedures (SOPs) and Work Instructions relating to QA/Document Control.
Proactively maintain an understanding of regulations and best practices for a robust Quality Management System e.g., FDA, USP, ICH, etc.
Support and take ownership in Quality Events related to Document Control, such as CAPAs, Deviations, Change controls, and Audit actions.
Responsible for tracking and reporting department metrics.
Maintain Quality tracking systems for controlled documents and data.
Assess effectiveness of current Document Control processes and implement improvements.
Provide training on document control and document change processes as needed.
Qualifications
M.S. or B.S. degree with minimum 3+ years prior hands-on experience with Document Control in the biotechnology or pharmaceutical industry that includes work on early-stage products. GED or high school degree with 4+ years of relevant experience may be considered.
Excellent organizational skills with a professional demeanor and the ability to work well in a team environment with cross-functional team members.
Experience preparing and reviewing cGMP documentation in support of manufacturing operations.
Working knowledge of 21 CFR Part 211 and 210, FDA/ICH guidelines, and industry/technology standard practices including GMP, GCP, and GTP.
Excellent writing skills and proficiency with MS Office applications, particularly Word and Excel.
Strong attention to detail and communication skills.
Able to work independently and prioritize tasks in a fast paced and dynamic environment.
Able to independently address issues of low to moderate complexity.
Working Conditions
On-call support may be required.
Subject to extended periods of sitting and standing, vision to monitor, and moderate noise levels.
$34 - $42 an hour
Equal Employment Opportunity Fate Therapeutics, Inc. is an equal opportunity employer. We value diversity and are committed to creating an inclusive environment for all employees.
#J-18808-Ljbffr