Job Description

SUMMARY

Effective training programs are critical in a regulated manufacturing business and this position plays an essential role in ensuring the training administration for manufacturing and support groups are compliant with regards to GxP, regulatory and industry standards and guidelines.

The Training Specialist's primary function is to ensure our learning management system is effective and efficient. He or she will interact with customers to streamline curricula within the LMS. They will ensure that customers are adequately credited for the training necessary to properly and consistently perform their functions, and assist in identifying and implementing improvements to processes that will lead to gained efficiencies and reduce costs.

This position reports through the training function within the Business Operations department and supports the Novato manufacturing site and its support groups.

This position is responsible for:

• Administration of the Learning Management System (LMS) to ensure seamless customer experience for the users of manufacturing and manufacturing support groups
• Provision of training reports in support of audit and inspection
• Leading or assisting department projects as needed

RESPONSIBILITIES

• LMS Administrative Requests Building training curricula in association with the customer department/group
• Supporting project on migrating to paperless credit system
• Processing of training assignment requests, including curricula and user group creation and modification
• Processing Node structure changes and the associated re-grouping of personnel
• Entering of training record data for non-LMS driven activities
• Integrating multiple types of e-Learning training modules into the LMS
• Creation, editing and archive of documentation as directed by department management
• Creation and delivery of custom reports as requested
• Maintain and update training database
• Additional Responsibilities Participate in internal and external audits and inspections
• Review documents (SOPs) and TNAs, provide feedback on the contents, and assess the training needs and requirements for new and revised procedures.
• Supporting department logistics as needed
• Deliver trainings as applicable
• Interact with customers across manufacturing and support groups to Address technical support inquiries
• Train on administrator tools and an ad-hoc and planned basis
• Guide/educate customers in the design of curricula and the associated implementation in the LMS to maximize efficiency and ensure consistency across learning content
• Support department logistics as needed

Skills

Required Skills

• Experience with :Effective customer service across all levels of business
• Administration of the LMS, ComplianceWire
• Application of data integrity best practices in a corporate environment
• Use of web-based database software applications

Desired Skills:

• 4-6 years experience of professional training experience
• 2-4 years in a regulated environment supporting highly technical processes (e.g. life sciences, energy, aviation, nuclear industries)
• Instructional design skills
• Excellent written and verbal communication skills
• Strong attention to detail
• Ability to comprehend technical information related to equipment, process and regulatory expectations
• Organizational skills to coordinately multi-discipline projects
• Problem solving and analytical skills
• Familiarity with: Biotech, Pharmaceutical and/or Medical Device Industry
• Proficiency in: Microsoft Office Suite – Excel, Outlook, Sharepoint, Visio, Word

EDUCATION:

Bachelor’s Degree in a technical discipline preferred (biological sciences preferred, but not required)

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