Validation Consultant

ID# DCCA26819

dinaliC is an international consulting firm specialized in projects for numerous industries. We are dedicated to provide contract and permanent opportunities for skilled professionals in their area or areas of expertise

JOB OVERVIEW 

PURPOSE:  

The Training Specialist is responsible for the implementation of compliance training programs for associates. Administers the training system to ensure compliance with QSR and ISO requirements. Develops / Updates Training Curricula by position.  Performs other work-related duties as assigned by Quality Systems Manager.  Follows current compliance regulations and standards.  Complies with all federal regulated programs.  Supports all corporate initiatives..

EDUCATION / EXPERIENCE REQUIRED:  

Bachelor degree is required. Concentration in education, psychology, computer science, information technology or business administration is preferred.  Five - eight years of industrial training and/or computerized training information technology administration experience preferred.  Experience in the implementation of a computerized training information system is preferable.  Demonstrated ability to communicate with individuals at all levels of the organization, prepare and impart instruction assignments to groups.  Capacities to plan, coordinate, organize, compile, analyze, evaluate, interview, negotiate, calculate and supervise.  Advanced computer skills and use of software application(s) preferred.  Also, requires statistical and analytical problem solving skills.

LANGUAGE SKILLS

English required.  Bilingual preferred (Spanish & English).

KEY JOB RESPONSIBILITIES:

Implements / administers the training documentation system (Compliance Wire) to ensure compliance with company policies and objectives and all applicable governmental regulations. 

Develops / updates Training Curricula.  Ensures that all training activities are properly documented.  Ensures that training records are correctly stored, and are readily retrievable.  Coordinates and assists in the development of training programs of all types and levels.  Distributes training and development information as published by J&J in support of regulatory compliance.  Recommends, coordinates, and follows-up associate participation in training programs to support organizational objectives, new projects, and/or associate development processes.  Assures all training activities are delivered in compliance with ASP’s training procedure.  Provides support for plant safety training requirements.  Assists in planning course outlines; identifies appropriate instructional methods, develops training aids, manuals and other materials; assists in formulating learning objectives; planning, designing and developing methods for the assessment and evaluation of training effectiveness; assists in assessing and analyzing training needs.  Evaluates training effectiveness and recommends modification to training; complies with and revises training contents and methodologies; compiles reports on training provided and maintains corresponding training records.  Coordinates training presentations and provides technical assistance; organizes, and conducts workshops about training system administration on specific problems as needed.  Works with other departments to implement compliance training that effectively addresses requirements of applicable laws, regulatory rules and local policies and procedures.  Reports compliance issues as they arise and reports metrics to Senior Management periodically, as requested or as scheduled.  Follows up on new compliance training system initiatives and technologies to ensure they are implemented as intended and in compliance with regulatory requirements. 

PHYSICAL DEMANDS: 

Must be able to lift/carry up to twenty-five (25) pounds audiovisual equipment.  Must have excellent communication skills, hand-eye coordination skills. Visual discrimination, up-close, far, 3-dimensional, peripheral, color scheme.

WORK ENVIRONMENT:  

Office environment and light work.  

SUPERVISORY RESPONSIBILITIES:  

Gives infrequent indirect supervision to others, as needed to achieve training system administration objectives.  No direct report supervisory responsibility.

ENVIRONMENTAL, HEALTH AND SAFETY:

All employees have a duty to care for their safety and for the safety of others whom may be affected by their acts or omissions at work and the environment.  Therefore it is the duty of every employee to:

  • Respect and apply safety rules and procedures at all times
  • Use personal protective equipment and safety devices as required
  • Promote industrial hygiene and safety matters
  • Report incidents and damages to management whether injuries are involved or not
  • Participate in incident investigation
  • Report hazards to management
  • Ensure a high standard of housekeeping in the work area
  • Be a safety role-model to all employees
  • Make suggestions to improve safety at the workplace
  • Actively participate in department EHS committee Engage in environmental awareness and participation towards ASP’s environmental goals and programs

COMPLIANCE:

All employees have a duty to comply with applicable laws, regulations, standards, and procedures.  Examples of required areas of compliance include but are not limited to:

  • Quality Systems (including Product Complaints, Corrective and Preventive Actions (CAPA), Internal Audits, Good Manufacturing Procedures (GMP), and Good Documentation Practices (GDP))
  • Sarbanes-Oxley (SOX)
  • Health Care Compliance (HCC)
  • Government Contract Compliance (GCC)
  • Environmental Regulations
  • Records Management

 

Position Details:

Medical Device

Engineering

Start Date: 
9-2-2013
End Date: 
8-25-2014

IRVINE, CA

Full Time

37.5

DCCA26819

No

No