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QA Documentation Specialist - I //Foster City, CA with a A Big Pharmaceutical Company
Ref No.: 18-29378
Location: Foster City, California
Start Date / End Date: 05/14/2018 to 11/13/2018
Job Title: QA Documentation Specialist - I
Work Location: Foster City, CA
Length of Assignment: 6 Months
Position Type: Contract Full Time
Client:  A Big Pharmaceutical Company

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.

If you are interested in this job than please send me your most updated resume on or you can reach me at #973-507-7579