Job Title: Quality Assurance Documentation Specialist
Location: Scottsdale, AZ
Zip Code: 85251

Description:

Overview :

The QA Documentation Specialist will play a key role in providing support to the entire quality and manufacturing team. This position is responsible for processing, controlling and storage of Quality records in accordance with established record retention schedules and applicable GMP/QSR regulations. In addition, the QA Documentation Specialist will be responsible for the administration of the Standard Operating Procedures and controlled document system.

The QA Documentation Specialist will interface directly with users to ensure internal satisfaction and conformance to company requirements, as well as with contract manufacturing partners. Daily duties include updating and maintaining paper and electronic files to ensure integrity and accessibility of documents, as well as routing and distributing controlled documents.

Responsibilities :

Responsible for maintaining and updating records in the Document Management system, both the paper and electronic archives - including scanning, indexing, and archiving product manufacturing and quality related documents required by GMPs. This includes building folders, creating labels and site files, retrieving documents and making documents available for viewing.
Responsible for supporting the maintenance of the Standard Operating Procedures Management Program, which includes processing new SOPs and revisions to existing SOPs, appropriately formatting SOPs and controlled forms, sending out email notification, and posting SOPs and controlled forms on the Intranet. Maintain the Master Index of SOPs and administer the biennial review program.
Responsible for administration of records retention schedules in accordance with applicable regulations and company policies. Train users in correct use of templates and assist users in understanding documentation and other procedures. Audit filed records and electronic files.
Word process documents according to established formats. Check documents for adherence to template, appropriate referencing, and good documentation practices and assist writers in creation of electronic documents.
Track documents and other records and expedite document lifecycle, requesting applicable effective copies from contract manufacturing partners.

Qualifications :

Minimum 2 years experience in records management
Bachelor's degree in a technical or scientific discipline preferred OR a high school diploma with 3 years experience in a GMP environment with records management experience
Must be proficient in all standard business application software and documentation and have experience working in a GMP environment
Must possess excellent interpersonal skills, a professional attitude and be able to work in a high-volume, fast paced environment
Experience in a regulated environment with a general knowledge of Good Manufacturing Practice of Drugs, Medical Devices and Biologics a plus

AA/EEO Employer

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