QA Training Specialist II (QMS) in San Diego, CA at Apex Life Sciences

Date Posted: 7/20/2018

Job Snapshot

Job Description


Under minimum supervision, the QA Training Specialist II supports the daily operations of the change management function as they relate to training compliance and the training process automation using the electronic learning management system (LMS).

Tasks and responsibilities:

•             The QA Training Specialist II facilitates the Change Control process in the configuration of training requirements.

•             Creates, publishes, and may present training course materials utilizing the Learning Management System or Instructor Led Training methods.

•             Works on training problems of diverse scope where analysis of situations or data requires evaluation of identifiable factors.

•             Identifies gaps and troubleshoots areas in training system configuration pertaining to system user requirements and validation activities.

•             Partners with cross-functional associates to meet training compliance requirements.

•             Guides change initiators in the assessment of training requirements.

•             Assists in the documentation of key processes and departmental procedures.

•             Demonstrates proficiency in the use of the electronic Learning Management System with regard to creating, maintaining, and archiving job codes, courses, and training plans.

•             Receives, classifies, files, and maintains Quality System training records

•             Compiles data for the creation of training metrics and reports for various departmental activities, such as past-due training.

•             Assist as required in regulatory inspection activities.

•             Work on continuous improvement projects as assigned by management.

•             Carries out duties in compliance with established business policies.

•             Demonstrates commitment to the development, implementation and effectiveness of Quality Management System per ISO, FDA, and other regulatory agencies.

•             Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices.

•             Understands and is aware of the quality consequences which may occur from the improper performance of their specific job. Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities.

•             Perform other duties & projects as assigned.

Education/Experience;

  • Bachelor’s Degree or equivalent from four-year university/college or technical school; or 2-5 years related experience and/or training; or equivalent combination of education and experience.
  • Intermediate knowledge of Microsoft Word, Excel, and other manufacturing systems.
  • Working knowledge of Quality Assurance in a medical device manufacturing environment, preferably in-vitro diagnostic.
  • Knowledgeable  of federal and other regulations, e.g. QSRs, ISO 13485
  • Able to work on multiple tasks as a team member and/or ability to operate as an individual contributor.
  • Must be detail-orientated, self-motivated and available for flexible scheduling.
  • Strong communication, written, problem solving, and motivational skills. 
  • Demonstrated ability to carry out assignments in a timely, accurate manner and accomplishing tasks as required with little or no supervision.
  • Ability to interact effectively with all levels of the organization and perform multiple tasks in a fast paced environment.

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.