Quality Systems Training Specialist - Sunnyvale, CA 

Duration: 12 Months

Location: Sunnyvale, CA 94086

 

Job Description:

Department:

Quality Systems and Compliance

 

Position’s Objective & Summary:

As a key member of client’s Quality System and Compliance (QSC) department, the Quality System Training Specialist is responsible for the development, management and continuous improvement of client’s Training Program processes.

The Quality System Training Specialist helps lead the client’s Quality Systems training function by interfacing with all functions that have internal client’s Quality System training needs associated with compliance for their respective function(s). The role is responsible for executing efforts to improve the design and delivery of the Global Quality System training strategy. This cross functional role works on the creation, tracking, and management of the training process and delivery of training events utilizing internal or external resources.

 

Roles & Responsibilities:

·         Execute on all improvement efforts related to client’s training process, working with Learning Management System (LMS) administrators and key stakeholders to evaluate training assignments and management processes, while ensuring training effectiveness and alignment of training to job function responsibilities.

·         Lead the creation and maintenance of new training curricula/training plans per core function and Quality System requirements. Curricula/training plans will be for regular and contingent workforce.

·         Participate in projects to determine training competency and effectiveness utilizing a risk based process approach.

·         Assist with improvements efforts and on-going maintenance of the training system including the updates to employees training curriculum.

·         Develop, maintain, document and implement structured methodology for life cycle management of training plans and reporting tools.

·         Collaborate with other training areas, including, but not limited to, HR, Sales, Manufacturing, and Customer Service to continuously improve training compliance across the company.

·         Provide on-going training support to LMS Administrators and employees.

·         Develop/promote company training communications, articles and other literature to promote employee training programs and awareness.

·         Manage, schedule, track and create training courses, assessments and exams in the LMS in support of training effectiveness.

·         Communicate at multiple levels of the company to gather information and prepare functional training curricula and training plans.

·         Analyze training administration related issues, compile and analyzes data, and prepare reports/recommendations.

·         Performs other functions as instructed by management.

Preferred Knowledge, Skills, and Experience:

·         Proficiency with BOXI application report generation and SAP is desired.

·         Experience with an Automated Change Control System (ACCS), preferably Agile (Oracle).

·         Experience generating, interpreting, and presenting training metrics.

·         Experience in providing accurate training data in the support of internal and external audit requests.

·         Creation of Computer Based Training (CBT) material.

·         Adept at educating others on the quality system training requirements according to established procedures.

 

Education:

·         Four year college degree, education and/or training certification or equivalent experience

 

Experience:

·         Minimum of 2 to 4 years training experience in a regulated industry; US Medical Device and/or Pharmaceutical industry.

·         Experience in the deployment, maintenance, and improvement of a company-wide training system.

·         Demonstrated proficiency with a Learning Management System (LMS) (e.g., Success Factors).

·         Ability to communicate training requirements and information at multiple levels (e.g., technician to management).

·         Proficient in interpreting training requirements to comply with the FDA regulation and international standards.

·         Experience with working with processes associated with GDP (Good Documentation Practices, GMP (Good Manufacturing Practices), especially pertaining to training, quality records, and training process improvements.

·         Excellent interpersonal and communication skills with the ability to negotiate and influence others.

·         Strong organizational skills with attention to detail; excellent English written and verbal skills.

·         Possess autonomous attributes to ensure the ability to manage own time and projects.

·         Demonstrated experience in creating and running data summary reports.


Thanks & Regards,
Manu Chhabra
Sr. Recruiter | Spectraforce Technologies
O: 919-230-9952 EXT-4186 | Email: manu.chhabra@spectraforce.com
500 W Peace Street, Raleigh, NC 27603
Visit us: www.spectraforce.com