Alma Chavez Email & Phone Number

United States

• Lead and Execute Quality Assurance continuous improvement projects related to Document Control and Training Processes• Coordinate and Provide Support with Change Packages for all Projects within the Annual Quality Improvement Plan • Responsible for Document Control processes, Good Documentation Practices and Change Order Submission Company-wide Trainings • Generate site reports and presentations for Document Control Quality metrics • Manage Signature and Initial Forms for all employees• Create and execute transition plan for Document Control role

Carlsbad, California

• Reviewing and/or investigating Nonconformance/CAPAs and develop effective corrective action plans.• Assess complaint information provided and conduct additional investigation as needed and escalate as appropriate.• Leading MRB, Management Review and QA Forum Meetings.• Reporting results for all Quality and Compliance metrics on monthly basis and during QA Forums and Management Review Meetings with Upper Management.• Reviewing quality records for compliance with site procedures, policies and other regulations.• Assisting with creation/revision of SOPs and Controlled Forms.• Subject Matter Expert on the above area during Internal and/or External Audits

Mira Mesa

• Lead and execute Quality Assurance process improvement projects related to Internal and External Audits, Management Review and Responsibility and Training Processes• Coordinating external agency, internal and corporate audits as needed• Manage and support training program• Responsible for Quality System, Good Documentation Practices and Audit Readiness Trainings delivery• Generate site and corporate reports and presentations for all quality metrics• Coordinating Management Review Meetings as needed• Report results for Audits, Quality and Business Improvement Plan and Training compliance on monthly basis and during Management Review Meetings• Manage signature and Initial forms for all employees• Provide support (management/execution) with CAPA, change requests and NCMRs/Qis• Review Batch Records as needed

Alere/Ameditech

• Work in coordination with Project Manager and Quality Assurance Manager to update existing labeling and create new or revised processes to comply with UDI (Unique Device Identification) requirements.• Ensure that UDI processes are designed, developed, and documented per the processes defined by Ameditech.• Submit DCO (Document Change Orders) for all Label Template updates and other related documents via ensur Database.• Support UDI team in preparing Validation Protocol.

• Managing systems for document storage and retrieval of all QMS and Training related processes, workflows, and training material • Work with Management to analyze QMS and Training related processes, workflows, and training material to ensure that the amount and detail of documentation is relevant to the desired results of the organization’s process activities• Help train employees on efficient documentation system usage and document control policies and procedures• Maintain Document Control Master Listing, Record Retention Matrix, and Approval Matrix• Ensures that the main objectives of the organization’s documented information are defined and acknowledged• Perform process audits to:- Corroborate compliance with current QMS documentation and identify opportunities for improvement, risks, and nonconformities.- Verify the effectiveness of the Training Program and Documentation system - Update Training Work Center Matrix as required based on findings- Update, develop and organize training materials and visual aids in coordination with Process Engineers and/or Department Managers- Review QMS records for accuracy to ensure that the company is eligible to maintain its ISO compliance status.

• Administration of Training Database, training Forms, and records• Conduct New Employee Training Orientation• Assist with interview and selection process for temporary workforce• Confidentially assist employees with Benefits related questions and concerns

• Responsible for overall coordination of controlled documentation within the company• Perform internal audits to verify compliance with current QMS documentation and identify opportunities for improvement• Assist in supporting external audits and ensuring timely response to documentation requests for auditors• Manage/Maintain the Product Deviation and Nonconforming Product processes, records, and reports

Ensure intake documentation complies with accreditation standards, policies and procedures and/or best practicesAssist in supporting external auditsRunning routine weekly internal reports Handling, scanning, copying, data entry, reporting, filing and archiving of official records

Setting and maintaining daily, weekly and monthly staff and client schedules Receiving and responding to staff and client inquiries related to schedulingMaximizing contract fulfillment and staff utilization through efficient scheduling

General office duties including maintaining supply inventories, mail and fax distribution, and photocopyingEnsured data documentation and filing for all Behavioral InterventionistsPreparing and distributing reports and other communications to families and funding sources

Creation and implementation of stress management workshops and leadership courses

Direct contact with clients such as VERIZON, AVON, AVIS, BUDGET, MetroPCS to determine training needs and results were above standardsEnsured ISO Quality Standard internal guidelines and requirements were metManaged and oversaw reports to be consecutive to internal staff and external clientsProvided feedback and coaching about performance to trainers

Operated skills workshops, quality and procedures training to current staffFollowed the ISO Quality Standard guidelines and requirements for potential hireesEffectively trained over 1200 Customer Service representatives