Quality eDMS / eLMS Analyst (Contract)
- Employer
- Global Blood Therapeutics
- Location
- San Francisco, CA, United States
- Start date
- Mar 16, 2019
View more
- Discipline
- Quality, Quality Control
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Biotech Bay
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QUALITY eDMS / eLMS ANALYST (CONTRACT)
Position Summary:
The primary responsibility of this position is assisting in the maintenance of the Quality Enterprise Management ecosystem including the electronic Quality Management System. This person will support and have visibility into: Document Management System / Learning Management System / Change Management / Investigation system and overall compliance. Specific responsibilities include: preparing and analyzing data, maintaining documents, supporting data migration, the resolution of root cause investigations, tracking closure, and verification of effectiveness.
Essential Duties and Responsibilities:
Qualifications:
Position Summary:
The primary responsibility of this position is assisting in the maintenance of the Quality Enterprise Management ecosystem including the electronic Quality Management System. This person will support and have visibility into: Document Management System / Learning Management System / Change Management / Investigation system and overall compliance. Specific responsibilities include: preparing and analyzing data, maintaining documents, supporting data migration, the resolution of root cause investigations, tracking closure, and verification of effectiveness.
Essential Duties and Responsibilities:
- Review incoming requests, identifying and coordinating the necessary next steps to resolve
- Interface with Quality and Operations to drive timely completion of review cycles, approvals and investigations
- Support regular business review, including data analysis, identifying trends and insights, and reporting of results
- Applies systematic problem-solving methodologies and technical skills in identifying, communicating and resolving competing priorities
- Maintains compliance to internal procedures, FDA, ISO and other regulations
Qualifications:
- Bachelor of Science, or equivalent work experience in
- While a computer science technical degree is not required, familiarity with technology and the use of IT solutions in business is desired
- Ability to quickly ramp up knowledge of business and quality management systems
- Fluency with MS office products, in particular, MS Excel
- Organized, detail-oriented, able to perform tasks methodically, and can employ critical thinking in problem-solving
- Ability to manage multiple simultaneous projects with attention to detail and delivery dates
- Able to escalate risk with the necessary urgency
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