Sr. Specialist, Document Control

Location
South San Francisco, California
Posted
Apr 18, 2018
Ref
N18-003-23-01
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time

ABOUT RIGEL:

Rigel is a biopharmaceutical company dedicated to the discovery and development of novel, targeted drugs in the therapeutic areas of immunology, oncology and immuno-oncology. Rigel's pioneering research focuses on signaling pathways that are critical to disease mechanisms. Our business strategy is to transition to a commercial-stage company with our Phase 3 results from fostamatinib in immune thrombocytopenic purpura (ITP), Rigel has submitted an NDA. We continue to build an extensive portfolio of products in immunology and oncology, monetizing select assets through attractive partnerships. 

POSITION SUMMARY:

The Sr. Specialist, Document Control will be responsible for the management, operation and upkeep of the Document Control System to support GxP (GMP, GLP, & GCP) programs.   The core function consists of, but is not limited to:  managing, developing, operating and maintaining the Document Control System used to create, maintain and control all Quality System Documentation, which includes, but is not limited to, SOPs, protocols, instructions, guidelines and related documents.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

This position will provide support for the preparation and maintenance of quality, manufacturing, testing, inspection, and clinical documents.  The responsibilities include, but are not limited to, the following:

  • Create, implement, and maintain a Document Control System (manual and/or electronic) that can manage both Internal (Rigel) and External (Contract Organization) Controlled Documents.  This responsibility includes, but is not limited to, the following:
    • Manage Document Change Request (DCR) System
    • Distribution of Internal Controlled Documents
    • Distribution of External Controlled Documents
    • Periodic Audits of Document Control Systems
    • If necessary, establish Documentation Control Guidelines
  • Process, monitor, and maintain all controlled quality system documentation in hard copy format and electronic systems used in a regulated design and manufacturing environment.  This responsibility includes the creation and implementation of document and record storage, but is not limited to, the following activities:
    • Maintain files for batch records for manufacturing lots
    • Maintain files for studies
    • Maintain files for non-conformances, CAPAs, investigations, and complaints
    • Maintain files for Audits (internal and external audits)
    • Maintain files for other documents that are part of the Quality System Documentation
  • Ensure accuracy and integrity of Document Control system (paper and electronic systems)
  • Assign document numbers
  • Provide support in processing contract organization requests (e.g., coordinating review and approval of contract organization-controlled documents) in a timely and efficient manner
  • Review documentation procedures and other documents to ensure compliance to relevant cGMP and cGLP requirements
  • Coordinate the approval process, including facilitation and execution of documentation through document change control process
  • Organizing, filing, scanning, and photocopying of all Quality System Documentation as required
  • Update and Maintenance of all Document Control logs
  • Provide relevant training on Document Control procedures
  • Perform other related duties and responsibilities to support Document Control and QA as defined by management
  • Create, implement and maintain Document Control System for Technical Protocols and Reports
  • File Stability and other miscellaneous QC data
  • Format and edit SOPs

 

 

KNOWLEDGE AND SKILL REQUIREMENTS:

  • Previous Document Control experience of 4 years or more
  • Basic knowledge of cGMP/GLP regulations highly preferred
  • Demonstrated skills in using Learning Management Systems (LMS)
  • Experience with SharePoint preferred
  • Strong computer skills. Excellent Word processing skills
  • Experience in Excel, PowerPoint and Outlook preferred
  • Strong technical writing and editing skills
  • Superior attention to detail and organization
  • Strong interpersonal and communication skills
  • Ability to handle changing priorities in a fast-paced environment
  • Must be self-motivated and innovative in addressing routine assignments

 

Rigel Pharmaceuticals Inc. is an Equal Opportunity Employer with a commitment to diversity. All individuals are encouraged to apply.