Technical Training Specialist

Job Description

Job Description

TITLE:   Technical Training Specialist

LOCATION:  Wilson, NC

HOURS:  Monday thru Friday (10 hours per day)

7am-530pm or 6am-430pm (flexibility on which schedule)

DURATION:  6+ months

Job Summary :

Responsible for performing and coordinating all training related activities for the Manufacturing and Packaging  teams, including collaboration with key personnel in other departments to ensure proper alignment with policies, procedures and GxP requirements .

Primary Responsibilities:

• Analyze, develop, deliver, document, and track training activities per applicable Standard Operating Procedures.
• Build training modules, skills demonstration checklists (“SDC”), curricula, work instructions and presentations  relevant to job expectations and regulatory requirements with the ultimate goal to achieve overall regulatory compliance,  job proficiency and personnel development and advancement.
• Work with Operations Management to support SDC process including management of training documentation, on-the-floor evaluation for consistent practices and final approval of successful process specific training completion.
• Team with Engineering as new equipment is implemented, or existing equipment is upgraded to ensure key technical equipment requirements are identified and highlighted to Operations personnel.  Communicate and implement necessary SOP, MBR, and SDC revisions.
• Provide technical support in revising Master Batch Records (MBRs). Work with Operations Management to maintain and create QDCS workflows.  Implement red line changes to existing MBR’s as directed by Operations Management.
• Support Operations Management in the training of updated SOPs and provide all necessary training forms and attachments required, coordinate training activities with SME to ensure all personnel are adequately trained.
• Directly monitor training needs as applicable to new procedure, revision and frequency training for all Operations     personnel to adequately ensure only fully trained personnel are involved in the production of pharmaceuticals.
• Provide technical support in drafting and reviewing Standard Operating Procedures (SOPs) and Skill Demonstration Checklists (SDCs).  Work with Operations Management to maintain and create QDCS workflows.  Implement red line changes of existing SOPs as directed by Operations Management.
• Monitor cross-training status of all employees across all departments within operations.
• Assist with tracking and utilization of Learning Management System (LMS)
• Prepare and communicate training metrics; Provide regular updates to Operations management on training status and initiatives
• Assist in change controls, CAPA’s, and deviations as needed in collaboration with key personnel in other departments.
• Provide Right First Time  (RFT) feedback and training to all Operations’ departments. 

Education and Experience Requirements :

• Bachelor's Degree; Area of study: Life Sciences, Education, or related STEM discipline.
• Minimum of five years of relevant GMP pharmaceutical industry with pharmaceutical/ biotechnology or similar background; three years of training experience including experience analyzing, developing, and implementing training programs.

Necessary Knowledge, Skills, and Abilities :

• Previous experience working with a Learning Management System or relevant on the job the training tools.
• Ability to relay technical information in a concise and simple format for trainees.
• Ability to collaborate with team to design effective PowerPoint  presentation including the ability to work with complex information and present it clearly; 
• Tech-savvy and proficient with Microsoft Office Suite, Teams, ARIBA or similar procurement, expense and spend management platform.
• The Technical Training Specialist has no direct reports