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Assignment Description: 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.
Performs other related assignments and duties as required and assigned.
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.
Strong written/verbal communication skills.
Highly motivated and detailed with good organizational skills.
Ability to train and mentor staff.
Possess the ability to multitask and work independently or in a team environment with minimum supervision.
Assumes total accountability for assigned duties.
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.
Supervisory Responsibilities (if Applicable)
The Technical Training Specialist has no direct reports.
Physical and Environmental
Perform job functions in various positions that may require sitting, stooping, balancing, kneeling, crouching, twisting, and/or reaching.
Ability to work standard schedule of 10 hours a day, Monday-Thursday and overtime as needed.
Additional Information
The job description is not an exhaustive list of all functions that the employee may be required to perform, and the employee may be required to perform additional functions.
Additionally, the company may revise the job description at any time.
Assignment Description: 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.
Performs other related assignments and duties as required and assigned.
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.
Strong written/verbal communication skills.
Highly motivated and detailed with good organizational skills.
Ability to train and mentor staff.
Possess the ability to multitask and work independently or in a team environment with minimum supervision.
Assumes total accountability for assigned duties.
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.
Supervisory Responsibilities (if Applicable)
The Technical Training Specialist has no direct reports.
Physical and Environmental
Perform job functions in various positions that may require sitting, stooping, balancing, kneeling, crouching, twisting, and/or reaching.
Ability to work standard schedule of 10 hours a day, Monday-Thursday and overtime as needed.
Additional Information:
The job description is not an exhaustive list of all functions that the employee may be required to perform, and the employee may be required to perform additional functions.
Additionally, the company may revise the job description at any time.