Quality Assurance Specialist - Doc Control

Location
Pleasanton, CA
Salary
Competitive
Posted
September 27 2017
Ref
55516BR
Position Type
Full Time
Job Description

Job Title: Quality Assurance Specialist - Document Control
Requisition ID: 55516BR

When you're part of the team at Thermo Fisher Scientific, you'll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you'll be supported in achieving your career goals

Responsibilities:

  • Assist Quality Assurance management with implementing various quality systems, particularly Document Control.
  • Supports Pleasanton operations by processing Agile change request orders, ensuring that records of change orders are complete and accurate, and that changes are approved in accordance with document procedures.
  • Serves as site subject matter expert on document control requirements and correct use of Agile workflows.
  • Provides training on Agile processes to site personnel and assists them with understanding Agile access requirements.
  • Responsible for maintaining documented procedures and work instructions for document control functions.
  • Represents Pleasanton site on multi-site team of Document Control Analysts.
  • Manages program for distribution of Laboratory Notebooks.
  • Maintains accurate records of notebook assignments.
  • Prepares clearly written business communications, including audit reports, email correspondence with internal/external customers, etc.
  • Participates in site internal audit program as needed
  • Supports Research- Use Only- (RUO) and GMP activities
  • Performs other duties and responsibilities as assigned


Minimum Qualifications:
  • Bachelor's degree, preferably in biology, chemistry, biotechnology or related science.
  • Minimum 2 years related Quality Assurance experience preferred, working in ISO 9001, ISO 13485 and/or GMP environments.
  • Quality auditing experience preferred, ideally in a biotechnology or medical device company.
  • Strong computer skills (MS Office, Visio, Project); experience with SAP, Agile and database systems preferred.
  • Positive attitude; works well under stress
  • Hands-on, action-oriented, and demonstrate a bias for continual improvement
  • Must have effective communication skills and demonstrated ability to work collaboratively and cross-functionally
  • Must demonstrate strong organizational skills and attention to details.
  • Must be able to acknowledge a sense of urgency and adapt to organizational changes.



Working conditions:

Works primarily in an office environment, but may also require time in laboratory/manufacturing environments


This position is not approved for relocation assistance


At Thermo Fisher Scientific, each one of our 55,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer. Apply today http://jobs.thermofisher.com
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.


*IND-LSG




Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.