Quality Assurance (QA) Documentation Specialist I
Kashiv Biosciences•Chicago, IL
•Onsite
About The Position
Kashiv BioSciences, LLC is a fully integrated biopharmaceutical company with global R&D, clinical, manufacturing, regulatory, and IP capabilities. The Documentation Specialist I is a full-time employee responsible for assisting with the review, issuance, control, formatting, reconciliation, and archival of controlled documents. This role also supports the maintenance of employee training files and curricula to ensure employees are current with their assigned training.
Requirements
- An associate degree or bachelor’s degree in life science, computer science, or other related field; or 1–2 years of experience in a training and/or document control capacity, preferably in a cGMP-regulated industry.
Nice To Haves
- Previous experience working in document control in training or a similar capacity is preferred.
- Previous experience with electronic document management systems is preferred.
- Previous work in a cGMP industry is preferred.
- MasterControl™ Electronic Document Management System Operation certification is preferred.
Responsibilities
- Assist with issuing and controlling Master Batch Records, Controlled Forms, Logbooks, Test Methods, Protocols, and Reports.
- Assist with issuing and routing Document Change Requests (DCRs) in the Electronic Document System.
- Scan batch records, validation documentation, calibration information, and supporting documentation, and post to the company portal as needed.
- Assist with auditing issued Controlled Forms, Master Batch Records, and Logbooks to support reconciliation and timely return of documents for final archival.
- Receive documentation and ensure documents are properly archived and easily retrievable.
- Ensure documents are properly formatted.
- Assist with template management to support harmonization among documents within the organization.
- Assist with tracking lead times for Document Change Requests.
- Provide routine status updates for pending document reviews in the Electronic Document System, as requested.
- Provide basic user support for the documentation system, including creation and monitoring of incident tickets requiring help desk support from the Electronic Document System Administrator.
- Assist change originators with coordination of document releases.
- Support implementation of efficiency improvements to the overall document control process.
- Assist the training team by tracking training files and completion of training modules.
- Upload PDF versions of procedures to the corporate portal.
- Support assigned projects and activities to meet the needs of Quality Management.
- Perform other duties and responsibilities as delegated by Quality Management.
Benefits
- Medical Insurance - Aetna Prescription Drug Converge | Rx Virtual Visits - Aetna/Teladoc
- Health Savings Accounts (HSA)
- Flexible Spending Accounts (FSA)
- Dental Insurance - Aetna
- Vision Insurance - VSP
- Life and AD&D Insurance
- Disability Benefits
- Supplemental Benefits
- Legal Services
- ID Theft Protection
- Travel Assistance
- Value Added Benefits & Services
- Health Advocate
- Life Assistance Program (LAP)
- Student Loan Assistance Program
- 401K
- Monthly Cell Phone Allowance
- Free Parking (Company Paid)
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
Associate degree
