Senior Quality Document and Training Specialist

Location
San Francisco, CA, United States
Posted
Nov 02, 2018
Ref
353
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
SENIOR QUALITY DOCUMENT AND TRAINING SPECIALIST

Position Summary:

The Senior Quality Training and Document Specialist at GBT is responsible for GxP training and document lifecycle management activities such as initiating, tracking, indexing, filing and archiving of all Global Blood Therapeutics (GBT) GXP documents. The document control system at GBT is a blend of manual and electronic documents.

Essential Duties and Responsibilities:
  • Manages the document control system and the implementation and enhancement of an eDMS to track and maintain documents. Maintains version control and configuration management.
  • Serves as administrator for the training program by interfacing with managers, staff and/or consultants for new and revised GxP SOP's and other GxP training requirements to update training plan / matrices
  • Manages the training program and the implementation and enhancement of an eLMS to assign and maintain training.
  • Develops and monitors performance metrics for training and the document control function
  • Oversees the document control processes which includes: prepare, review, finalize, and circulation of SOPs, forms, specifications and other GXP documents, including biennial review to archive documents within electronic and physical repositories;
  • Author and revise documents, as necessary
  • Ensures proper security access and maintenance for all original documents;
  • Support regulatory filings as needed;
  • Participates in internal and external GXP audits;
  • Assists in developing and revising GBT SOPs and controlled documents to support GXP regulated activities;
  • Maintains logs for assignment of document numbers and tracking of controlled documents;
  • Manages GXP documents posted on the company intranet

Qualifications:
  • Bachelor's degree in a scientific-related field or equivalent experience and 4-6 years' experience in the life sciences industry performing document management processes;
  • High level of professionalism and collaboration in team settings;
  • Demonstrated ability exercising superior judgment and working independently with minimal supervision and/or guidance;
  • Ability to manage tasks with competing priorities or deadlines;
  • Ability to understand/ implement written and verbal instructions to all levels of the organization;
  • Experience with Quality Management Systems
  • EDMS Implementation and training experience, preferred;
  • Lean Six Sigma experience, preferred
  • Technical expertise must include Microsoft Office Suite including Sharepoint
  • Successful experience in fast-paced entrepreneurial environment.


Fit with GBT culture:
  • Ability to build strong relationships with co-workers of various backgrounds and expertise
  • Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor
  • Values-based leadership consistent with GBT's Core Values
  • Excitement about the vision and mission of GBT
  • Flexibility
  • Integrity


NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.

Global Blood Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or any other characteristic protected by law.