Quality Assurance Trainer

Location
San Diego, CA, United States
Posted
May 12, 2019
Ref
217
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time
Quality Assurance Trainer

Job Summary:

Accountable for the management of the site Training Program including development, scheduling, database management and presentation of training materials as needed. Participate in Project Teams as they relate to the site including the roll out of the Learning Management System (LMS). Work with other Emergent facilities to harmonize training.

The Training Specialist is responsible for managing and administering the following:

Training Responsibilities:

-Site Training Coordination.

-Manage the Learning Management System (LMS), site point of contact.

-Distribute revised SOP's to the applicable departments for employee training.

-Support and partner with the internal departments in San Diego and Redwood City that -require training management.

-Support the eDocs team for workflow development and training issuance.

-Develop training plans and job aids as needed - Instructional Design

-Assist employees with memberships and training programs for further employee development.

-Schedule training for internal and external classes.

-Maintain a reference library for guidance documents and training materials.

-Develop effective GMP, GLP and GCP training classes, as applicable

-Assist the management team with on-boarding of new employees

-Creating monthly Quality Management Review metrics for training

Document Control Responsibilities:

-Serve as primary backup for Document Control

-Responsible for creating and approving Quality documents- SOP, Work Instructions, Policy as assigned.

-Responsible for the current SOPs as they pertain to writing, revision, implementation and training.

-Interfaces with all levels of Emergent employees.

-Other assigned responsibilities as established by Site Quality Head.

Compliance:

-Comply with all Federal, State and Local regulations

-Comply with all FDA standards and SOX regulations

-Comply with all GxP, CDC, ICH, EHS, OSHA and EPA regulations

-Comply with Code of Conduct, Employee Handbook, Compendia, E-time guidelines

-Ensure department personnel fully support compliance-based activities by maintaining current training requirements.

-Participate in and provide SME resources to support all FDA and non-US regulatory audits and technical discussions

Education, Experience & Skills:

-Bachelor's in science or related degree

-Must have experience in Instructional Design.

-Prior experience with US and EU pharmaceutical regulations, and training in a Pharmaceutical environment

-Development of training plans, agendas, training curricula, as well as, application of GMP principles, and working in an FDA regulated environment

-3-10 years progressive experience planning, managing training programs, developing programs to support organizational needs and conducting GXP training programs

-Critical analytical skills, strong verbal and communication skills

-Ability to work under pressure and analyze processes within scheduled timeframes

-Proficiency using PC software programs, including PowerPoint, Excel, Word, Outlook, Internet Explorer, Visio, SAP, and LMS.

-Excellent presentation skills, including written and verbal communication.