Quality Assurance Documentation Specialist I - $8,000* Sign OnUnited States - Maryland - FrederickQualityRegular
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.
- 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.
- 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)
- 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.