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Document Control Analyst I

Scantibodies Laboratory Santee, CA
  • $14.00 Hourly
  • Full Time
  • Employer Very Unlikely to Respond

Summary:

Candidates must understand the theories behind Training Administration and Document Control and reference the applicable regulations and standards and convey an understanding of the Scantibodies Document Control System and communicate and train others on its requirements.  To convey an understanding of the Scantibodies Training Program and communicate to others the need for all of its requirements.  To understand why Training and Document Control are important in the creation of quality products and cite examples of how a poorly designed/complied with Training Program and Document Control System could adversely affect final product.  To understand the Scantibodies Quality System and seek to develop the ability to reference procedures to illuminate the SLI policy in regards to specific regulations and standards.  To possess an “expert knowledge” of word processing programs to process and record training records in a timely manner.  To possess an expertise in generating matrices using Excel.  Will be able to ensure that Training Administration meets all the requirements of the Training Program and perform in an effective and efficient manner.  To understand cGMP and ISO 9001 Standards and serve as a model for compliance to the regulations and standards in all aspects of the job.

Essential Duties:

  • Generates/maintains matrices using Excel Spreadsheet software and analyzes matrices for completeness of requirements and compliance to current standards that are in place.
  • Updates/maintains training requirement assignments using current matrices as well as employee change notifications within the SmartSolve Quality Management software.
  • Enters training completion information into the SmartSolve Quality Management software and updates/maintains training files, includes filing completed training records into the Training files after completion has been recorded in Conductor.
  • Issue documentation to departments upon CO completion as required. This includes electronic file maintenance and data entry to SmartSolve and Excel database to reflect current information.
  • Creates and maintains databases to track all documents issued, distributed, and obsoleted. Works closely with other department members to insure that documents have been distributed or removed from points of use in a timely manner.
  • Analyzes new documents and documents submitted for changes to determine whether the controls written into the document are consistent with other similar documents and to determine how the change will affect other documents. Suggests additional controls and communicates with QA Management to determine whether additional controls should be added or removed from documents.
  • Processes documents using word processing software. This involves the creation and/or modification of procedures, forms, and diagrams which serve as the Device Master Record. The processing involves “expert” knowledge of Microsoft Word software to ensure that procedures can be easily usable from a formatting standpoint.
  • Provides administrative support to department managers as needed for special projects.

Equipment used:

Personal Computer

General Office Equipment

Job Specifications:

Associates degree or equivalent work experience required.

Candidates must have minimum of two (2) years experience in a medical device or pharmaceutical environment with at least one (1) year in the quality field and a minimum of two (2) years of Document Control experience.

Candidates must be familiar with QSR (cGMP) and ISO 9001 (including ISO 13485) standards.

Candidates must possess “expert” knowledge in the use of computer applications such as Word Perfect, Excel, and Access and be proficient in drawing and flow chart creation software.

Our Goal at Scantibodies is to see that each Patient receives the Most Accurate Result, using the Most Accurate Guide,so that they may receive the Most Accurate Treatment. Because at Scantibodies it is all about the Patient ...At Scantibodies, we believe that being your contract manufacturer is more than just an account. It is about trust and accountability. It is about taking your prototype to production for market readiness or making your current process more cost effective by using lean manufacturing concepts. Those are just a few of the many attributes that have made us a leader in contract manufacturing.

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