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QA Documentation Specialist - I
Ref No.: 18-05973
Location: Foster City, California
Position Type:Contract
Start Date / End Date: 05/14/2018 to 11/13/2018
Job Responsibilities ¿

Collaborates with customers to ensure the correct and timely implementation customer requests and document processing.
¿ Supports the distribution and maintenance of GXP documentation.
¿ Scans, verifies and archives documentation as needed
¿ Recommends process improvements and proposes changes.
¿ Provides support with internal and regulatory audits/inspections as required.
¿ Understand and use document templates.
¿ Supports the maintenance of monthly document control metrics.
¿ Performs general word processing tasks and support. Checks format and conformance to document templates, verifies own work.
¿ Provides additional support and assistance on tasks and projects as directed by management.
¿ Participates as required in training on issues affecting own area of work. Notifies manager of compliance questions and issues.

Knowledge & Skills ¿

Demonstrates knowledge of Document Control fundamentals, Quality Systems and GMP requirements.
¿ Demonstrates general knowledge of the processes and impact of document control, and the relationship between the document change process and products.
¿ Demonstrates basic understanding of the current pharmaceutical industry and applicable regulations including 21 CFR, GxP, ICH, etc.
¿ Demonstrates working knowledge of Electronic Document Management Systems (EDMS).
¿ Keeps abreast of the basic requirements for compliance in own work area.
¿ Demonstrates a high degree of attention to detail
¿ Demonstrates problem solving skills.
¿ Demonstrates proficiency in Microsoft Office applications Oracle environment.
¿ Demonstrates strong verbal, written, and interpersonal communication skills.

Typical Education & Experience ¿

5+ years of relevant experience in the pharmaceutical industry and a High School diploma.
3+ years of experience and AA degree.