Quality Assurance, Document Control

Location
Bothell, WA, United States
Posted
Nov 25, 2018
Ref
oVhx7fwA
Hotbed
BioForest
Required Education
Bachelors Degree
Position Type
Full time
Summary:

This position will be responsible for the operation and upkeep of the Quality Assurance Document Control System to support GxP programs. The core function consists of day to day Electronic Data Management System (EDMS) tasks and the support of the electronic document library system.

Responsibilities:

This position will provide support for the preparation and maintenance of GMP documentation for both in-house and contract organization documents. Additionally duties and responsibilities are:
  • Working in the current Document Management System overseeing consistency and uniformity of documents as well as shepherding them through the revision and approval work flow process
  • Assist with the Biennial review process for GMP documents
  • Create, issue and reconcile Controlled Forms
  • Create, issue and reconcile Controlled Logbooks
  • Create E-Forms
  • Controlled SOP binder distribution
  • Cross train on other document control functions


Qualifications:
  • Position requires BA/BS diploma or equivalent job experience and 0 to 2 years' experience in the pharmaceutical/biotechnology industry.
  • This position requires superior computer skills with MS Word, Excel, Adobe, database applications, and EDMS (e.g., MasterControl/DCA/Documentum) experience.
  • Requirements also include the ability to work with limited supervision, superior attention to detail and organizational skills, excellent grammatical and proofreading skills, proven multi-tasking abilities, immediate response action to tasks and personnel requests for assistance, strong interpersonal and communication skills, and ability to handle changing priorities if needed in a fast-paced environment.
  • Basic knowledge of cGMP regulations for documentation practices is highly desired.
  • The successful candidate will be able to maintain a high degree of confidentiality and professionalism and be able to work well with employees at all levels of skill and authority throughout company.
  • Desired qualifications include an Associate's Degree in a related field and experience utilizing a validated Electronic Document Management System (EDMS).

As the leading employer in our industry in the Pacific Northwest, Seattle Genetics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seattle Genetics, please visit www.seattlegenetics.com.

Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law.