Job Listing: Document Management Supervisor

A reputable Diagnostic company in Los Angeles is seeking a Document Management Supervisor.


Purpose of the Position:
This position is responsible for the implementation of quality tactical activities and document control management to assure compliance to the company’s quality system requirements, Federal/State regulations, and ISO standards.

Essential Duties and Specific Responsibilities:
*Primary site administrator and implementer for the Pilgrim SmartSolve Software (SmartDoc, SmartCAPA, SmartComplaints, SmartTrain).
*Member of the sites Quality Team for the effective implementation of the Quality Policy and Quality Systems, including editing of Quality Manual and SOPs.
*Leads the document control management system within company’s quality system and implements necessary improvements within electronic systems capabilities, i.e. Pilgrim SmartSolve Software and QAD ERP system.
*Identifies GMP/QS training needs. Conducts training for staff across functional areas and evaluations as required to assure staff proficiencies.
*Participates in compliance audits with government officials of regulatory agencies and certifying bodies.

Supervisory Responsibilities:

*Assures the current Quality System Will support all OMD products to comply with specifications, policies and SOPs.
*Participate in audits of external quality/regulatory products and processes.
*Monitors reports for tracking document control.
*Implements the enterprise-wide validated software tools for document control, CAPA complaints, and non-conformances.

Requirements:

*Bachelor Degree is preferred in library science or technical discipline in the sciences, life sciences, or engineering.
*3-5 or more years of relevant FDA regulated industry experience as a Document Control Specialist.
*Desired current GMP /QS regulation technical knowledge of 21CFR Part11 compliant electronic enterprise type systems for document management in FDA regulated industries (Medical Devices, IVD, Pharma).
*Desired experience with product structures and design transfers during development of medical device products in a regulated environment, preferably in a company manufacturing diagnostics products for the clinical lab and/or doctor’s office market.

Salary: 50-55k

To inquire further, please contact Marissa Peretz at 310 851 2083 or email mperetz@aerotek.com

Required Skills for Document Management Supervisor Job:

About Aerotek Scientific:

Join Aerotek Scientific LLCSM, one of the fastest growing providers of scientific and clinical research services in the nation. Due to our growth, we're constantly on the lookout for qualified professionals to place in contract, contract-to-hire, and permanent placement positions across the scientific and clinical research communities. At Aerotek Scientific, we know it's more than just your day-to-day responsibilities that can make or break a job. It's the support you get. That's the reason Aerotek Scientific offers a variety of benefits including medical, dental, optical, 401k, and many more. Don't put your career in the hands of just anyone, put it in the hands of a specialist. Join the Aerotek Scientific team! Allegis Group and its subsidiaries are equal opportunity employers.