QA Document Control Specialist - Brisbane, CA | Biospace
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QA Document Control Specialist

Aimmune Therapeutics

Location:
Brisbane, CA
Posted Date:
7/31/2017
Position Type:
Full time
Job Code:
17-85-QA-N
Salary:
Required Education:
Associates Degree
Areas of Expertise Desired:
QA, Quality,

Job Description


The QA Document Control Specialist at Aimmune Therapeutics will oversee and/or assist all facets of document control activities that establish quality systems (QS) compliant with current GxP requirements. The position supports other quality systems resources for the entire product life cycle associated with the development, production, and distribution of Aimmune products.   The position reports into the QA Manager responsible for Document Control.

Responsibilities:

•   Represent QA Document Control, as needed
•   Process and finalize Quality System documents and document change requests (DCRs), including making documents effective, superseding, obsoleting, watermarking, stamping, scanning, filing, and notifications to appropriate GxP personnel when new documents require training.
•   Maintain QA controlled documents file room and update electronic logs for Quality Documents stored in the QA File Room, to keep current and prevent duplications of numbers.  
•   Maintain the Effective SOP List and in parallel maintain the Training Matrix Template
•   Prepare training binders for new employees, process paper GxP training records and keep electronic GxP Personnel Training spreadsheet current.
•   Review, edit, format SOPs and assist with creation of other documents, as needed
•   File and maintain manufacturing and supply chain records
•   Maintain current list of GxP controlled signatures
•   Assist in implementation of EQMS

Note: Other duties may be assigned, as needed.

Requirements


Requirements:

•   Minimum of A.A.S. in Business Administration or Science field.  
•   A minimum of 5 years of experience in the pharmaceutical industry in Document Control or Quality Assurance.
•   Advanced skills in Microsoft Word, Excel and PowerPoint.
•   Excellent written and verbal communication skills and excellent interpersonal skills are a must.
•   Must have a good understanding of FDA/GMP requirements related to documentation.

Special skills/knowledge:

•   Electronic Document Management Systems.
•   Results and goals oriented.
•   Ability to effectively prioritize with good time management.
•   Excellent computer skills.
•   Accuracy and attention to detail
•   Organized work habits.
•   Internal audit and regulatory inspection experience preferred