QA Documentation Specialist

Proclinical is currently recruiting for a QA Documentation Specialist with a biopharmaceutical company located in Foster City, CA.

Job Responsibilities:

• Collaborates with Document Owners to ensure documents are classified correctly.
• Initiate documentation changes to update compliance documents with new GVault system document number.
• Conduct document impact assessment for document obsolescence.
• Understand and use document templates.
• Performs word processing tasks and support in the revision and formatting of documents. 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.
• Keeps abreast of the basic requirements for compliance in own work area.

Skills and Requirements:

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

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Zachary Hines at 215-531-6914 or upload your resume on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

#LI-ZH1

#Compliance/Quality