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Job Description

Job Title

Document Control Specialist, Quality Assurance

Requirement ID

65962

Begin Date

6/21/10

Duration

Location

Bothell, WA 98021

Other Location

Description

The Quality Assurance group is looking for a Document Control Specialist that will be responsible for the operation and upkeep of the Quality Assurance Document Control System to support GMP, GLP, and GCP programs. The core function consists of day to day Electronic Data Management System (EDMS) tasks and the support of the electronic document library system.

DETAILED DUTIES & RESPONSIBILITIES:
This position provides support for the preparation and maintenance of manufacturing, quality control, bioanalytical testing, and clinical documents (SOPs, test methods, protocols, etc.) for both in-house and contract organization documents which are maintained in the EDMS.

This position is also responsible for maintaining the QA Technical Library including tracking and guiding all documents from initiation through the release stage; requiring scanning and maintaining technical reports to support development activities, using Adobe for document conversion, maintaining and developing databases within the Technical Library System.

This position will also assist as an archivist role to control and maintain the file room and inventories for documents maintained on and off-site and support the GLP records program.

Ancillary duties include support for change control processes and training systems.

Required Skills

QUALIFICATIONS/REQUIREMENTS:
- BA/BS diploma or equivalent job experience and minimum 2 years experience in the pharmaceutical/biotechnology industry
- Superior computer skills with MS Word, Excel, Adobe, database applications, Java Script and EDMS experience
- 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
- Ability to handle changing priorities if needed in a fast-paced environment.

Basic knowledge of cGMP and GLP 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 Associates degree in a related field, such as computer processing, and experience utilizing a validated Electronic Document Management System (EDMS).

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