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Quality Assurance Documentation Specialist I - $8,000* Sign On

United States - Maryland - FrederickQualityRegular

Job Description

Everyone at Kite is grounded by one common goal – curing cancer. Every single day, we seek to establish a direct line between that purpose and our day-to-day work.

Reporting into the Sr. Manager, Document Control we are looking for a QA Documentation Specialist I to work in our state-of-the-art facilities here in Frederick, MD.

Responsibilities:

  • Provides clerical and administrative support related to documentation processes and systems.
  • Pre-approves and routes documents for review and approval in the electronic Document Management System (DMS).
  • Approves Document Change Controls and assigns effective dates to documents.
  • Pre-Releases documents for training and adds documents to curricula in the electronic Learning Management System.
  • Maintains the document archival room.
  • Responsible for filing and maintenance of all controlled documents and records. Ensures files are accurate and easily retrievable.
  • Creates logbooks to be used in production.
  • Issues lot related documentation and labels for manufacturing process.
  • Issue GMP documentation for execution including qualification and test methods
  • Scans, verifies and archives documentation and records as needed.
  • Performs general word processing tasks. Checks format and conformance to document templates. Ensure the correct and timely input of database entries.
  • Provides support to clients on the process of documents in the DMS. and word processing tasks as needed.
  • Participates in function meetings.
  • Notifies manager of compliance questions and issues.
  • Provides additional support and assistance on tasks and projects as directed by management.
  • Willing to work on a weekend shift as needed.

Basic Qualifications:

  • Master’s Degree and OR
  • Bachelor’s Degree and 2+ years’ experience in Document Control, MS Word, Excel, Power Point, Adobe Pro, and electronic document management systems (Document Locator, Documentum, Veeva or equivalent) OR
  • AA Degree and 4+ years’ experience in Document Control, MS Word, Excel, Power Point, Adobe Pro, and electronic document management systems (Document Locator, Documentum, Veeva or equivalent) OR
  • High School Degree and 5+ years’ experience in Document Control, MS Word, Excel, Power Point, Adobe Pro, and electronic document management systems (Document Locator, Documentum, Veeva or equivalent)

Preferred Qualifications:

  • Current Good Manufacturing Practices (cGMP) and Pharma Industry experience.
  • Labels printing with Zebra printers experience.
  • Knowledge of Oracle EBS and electronic archive systems (i.e. FileTrail)

Does this sound like you? If so, apply today!

* This Position qualifies for a $8,000 Sign-on Bonus, $4,000 payable within 30 days of start date and $4,000 payable following 6 months of continuous employment. Payments are subject to a 1-year repayment agreement from date of payment issue.  Applies to external hires only.

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