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QA Specialist - I in Foster City, CA at Apex Life Sciences

Date Posted: 11/28/2018

Job Snapshot

Job Description

Apex Life Sciences is looking for a few individuals who can work as Document Associates with one of our clients who is a large pharmaceutical company that has a facility sitting in Foster City, CA

If this looks like something you would interested in, please contact Dani Saunders, National Recruiter, at 503-345-2614 or at Details are below. 

Job Responsibilities

  • Collaborates with customers to ensure the correct and timely implementation customer requests and document processing.
  • Converts documents to current template format
  • Analyzes Document Change Requests (CRs) for completeness.
  • Collaborates with customers to ensure document changes are concise and complete.
  • Facilitates the routing of documents in the Electronic Document Management System (EDMS).
  • Performs word processing tasks including providing support to customers with documentation issues.
  • Supports the maintenance of monthly document control metrics.
  • Provides additional support and assistance on tasks as directed by management which support filings and projects.
  • Participates as required in training on issues affecting own area of work. Notifies manager of compliance questions and issues.
  • Knowledge of computer systems which support document control processes
  • Interacts with appropriate departments to establish project priorities and deadlines
  • Provides support with internal and regulatory audits/inspections as required.
  • Scans, verifies and archives documentation as needed

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
  • Demonstrates ability to learn and adapt to various computer applications quickly.
  • Demonstrates strong verbal, written, and interpersonal communication skills.

Typical Education & Experience

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

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.