QA Documentation Associate

Job Description Manage, execute and train on processes for Quality Controlled documentation using an electronic document management System.

Provide Quality technical edit and review duties as required to ensure timely advancement of documents and compliance to internal and GxP requirements.

Develop and conduct training sessions on QA Documentation topics and tools to supported business areas.

Work with supervisor of the Corporate Quality Documentation (CQD) group to ensure development and maintenance of streamlined processes for document management supported by the CQD group, including communication, periodic review, distribution, archiving and metrics. Review issues for continuous improvement and propose potential solutions to CQD management that evaluate risks and implementation feasibility.

Provide CQD representation on functional teams supporting the operations of QA documentation groups at Biogen Idec.

Qualifications
Minimum of 5 years experience in a regulated environment, preferably pharmaceutical operations and/or medical device.

Strong organizational skills, attention to detail, oral and written communication skills.

Strong knowledge of cGMPs and Regulatory guidelines.

Thorough understanding of biotech/pharma development/manufacturing processes.

Proficient in MSWord. Good working knowledge of electronic documentation systems.

Crystal Reports development experience desired.

Demonstrate ability to resolve issues with customers independently and a commitment to customer service.

Education
Batchelor degree in a science or business discipline. 5+ years of experience in a regulated industry.