Quality Documentation Specialist I – GMP & EDMS

1110 Kite Pharma, Inc.; Frederick (MD); On-site; USD 80,000 - 104,000; Full time

Benefits offered by this job

Bonus eligibility

Stock-based incentives

Paid time off

Benefits package

Job summary

Kite Pharma, Inc. seeks an experienced Document Control Specialist to ensure timely implementation of Change Requests, maintain accuracy of documentation, and support internal and regulatory audits.

Responsibilities include inputting database entries, maintaining GXP documentation, creating templates, and assisting with monthly metrics while contributing to process improvements in a highly regulated pharmaceutical environment.

Qualifications

• Advanced knowledge of Document Control, Quality Systems and GMP.
• Familiarity with EDMS and regulatory requirements.
• Attention to detail and problem solving.
• Proficiency in MS Office; Oracle background.
• Strong verbal and written communication.

Responsibilities

• Ensures correct and timely implementation of Change Requests and Documents.
• Maintains documentation manuals to ensure accuracy and current information.
• Inputs database entries and verifies own work.
• Supports distribution and maintenance of GXP documentation.
• Scans, archives, and recommends process improvements.
• Assists with internal and regulatory audits/inspections as required.
• Provides user training for electronic systems as applicable.
• Creates and maintains document templates and metrics.

Skills

Document control

GMP compliance

EDMS

MS Office

Oracle

Attention to detail

Verbal & written comms

Education

High School diploma

AA degree with 3+ years experience

Tools

EDMS

Oracle environment

Microsoft Office

Job description

Kite Pharma, Inc. seeks an experienced Document Control Specialist to ensure timely implementation of Change Requests, maintain accuracy of documentation, and support internal and regulatory audits.

Responsibilities include inputting database entries, maintaining GXP documentation, creating templates, and assisting with monthly metrics while contributing to process improvements in a highly regulated pharmaceutical environment.