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Responsibilities:

• Excellent employment for a QA Associate in the Fremont, CA area.
• The Senior Associate will provide general guidance and support DMS activities.
• Routinely performs administrative tasks to support the creation, revision, and retirement of controlled documents according to SOP's to support current Good Manufacturing Practices operations.
• Participates in project teams to meet timelines.
• Support the Electronic Document Management System (EDMS) for Company Fremont.
• Provides 2nd level business support and issue resolution, documentation and configuration, delivering workshops with/for Key Users, and facilitating training.
• Supports the management and audit of vital records and electronic records and provides records management system support to record owners.
• Support continuous improvement in business processes and records themselves.
• Manage controlled documents for the Fremont site, to ensure correct implementation, access, and upkeep of documents.
• Acts as key point of contact for users and provides customer support and troubleshooting for creation and editing of documents and workflows.
• Distributes document links to the appropriate viewers.
• Support training relating to DMS processes, templates and electronic systems to Company Fremont staff.
• Provides local business administrators with information about the appropriate roles for document signatories.
• Support with focusing on DMS continuous improvements.
• Support documenting the required configuration according to global standards, configuring the application according to specification and, where appropriate, testing the configuration prior to use in Production.
• Support technical actions required to make local configuration support current business needs for document management.
• Administers and processes records within the B4 High Density File room.
• Provides inspection/audit support for retrieval and archive of records; performs annual audit of records; provides customer support for all information relating to records and document management; and ensures records are archived in accordance with local archival standards.
• May participate in regularly scheduled international user-based teleconferences and face to face meetings.
• Meeting regularly with user community representatives to identify particular problem areas and determine solutions.
• Provides input into content on the EDMS.
• Support technical actions required to make local configuration support current business needs for document management.
• DMS best practices within GXP regulations.
• Standard Operating Procedures, Good Manufacturing Practices, Food and Drug Administration, and other national and international regulatory requirements related to DMS quality systems.
• Issuance and maintenance of controlled documents, implementation, access, and upkeep of documents.
  

Experience:

• High School Diploma or equivalent 5 years of progressive experience with Controlled Documents (SOPs, manufacturing and testing specifications, Validation documents, and/or document version control experience within DMS and Quality System.
• Associates Degree or Biotechnology Vocational Training with 3 years closely related experience with Controlled Documents (SOPs, Manufacturing and testing specifications, Validation documents, and/or Bachelor's Degree, preferably in a Science or Engineering related field
• A minimum of 1 year closely related experience with Controlled Documents (SOPs, manufacturing and testing specifications, Validation documents, and/or document version control experience and Quality Systems.
• Document version control experience and Quality Systems.
• Knowledge and ability to judge what information should be passed on to different levels of management or organizational units.
• Demonstrate analytical skills and a systematic approach to problem-solving, with an emphasis on process development and optimization, not just system maintenance.
• Demonstrate ability to deliver solutions in a timely fashion under rapidly changing conditions.
• Proficiency in MS Office Suite
• Schedule: Monday to Friday, 8:00AM - 5:00PM
• Required Skills: DOCUMENT CONTROL, EXCEL, EDMS, ACROBAT, MICROSOFT WORD
• Additional Skills: DTD, HTML, PDF, TRADEMARK, WORD, LINUX