• Training Manager

    Posting Date 1 week ago(6/12/2018 9:57 AM)
    Requisition ID
    2018-4717
    Job Location(s)
    Pittsburgh PA United States
    Position Type
    Full Time
    Company
    Cook Myosite Inc.
    Category
    Quality
  • Overview

    Cook MyoSite Incorporated, a division of Cook Incorporated, is a growing, forward-thinking biotechnology organization seeking a full time Training Manager.  The Training Manager is responsible for the development, implementation and maintenance of the training program to ensure that MyoSite personnel are knowledgeable, qualified and adhere to internal policies, procedures and requirements related to their functional role. This role also ensures the training program complies with applicable regulatory requirements and industry standards and acts as a champion of continuous improvement for training and learning development programs.  The Training Manager will ensure excellence in training practices, adult learning and course development knowledge, human errors management, and commitment to quality processes.  The Training Manager has a major responsibility to ensuring cGMP training processes. 

    Responsibilities

    • Implement and manage the training program to ensure compliance with regulatory requirements
    • Collaborate with area management to develop and manage personnel training plans in alignment with employee’s functional role
    • Lead the development and implementation of standardized competency-based training program, working in conjunction with functional leaders, subject matter experts and training specialists.
    • Analyze training needs across the organization and ensure ongoing training requirements are delivered to all employees
    • Develop, maintain, trend and continuously improve site training program, including conducting effectiveness checks to ensure program applicability
    • Identify learning and training gaps and advise the leadership team on mitigation solutions
    • Implement measurement criteria to assess the effectiveness of the training program and report training compliance metrics to management
    • Develop multifaceted training delivery methods to utilized varied learning abilities within the workforce
    • Act as site electronic Learning Management System administrator, providing end user support and maintenance of user accounts, learning plans and training items

    • Develop process for qualification and disqualification of trainers
    • Act as lead trainer, and/or coordinate training sessions for GMP operations
    • Act as Training impact assessor during document and change control process
    • Collaborate with Human Resources team to develop and manage onboarding of new employees, monitor performance of employees and disqualify employees as needed
    • Participate as Subject Matter Expert of training processes and training records and reporting during regulatory inspections
    • Maintains understanding of new educational and training techniques and methods
    • Investigate and respond to Quality System issues identified in the training system
    • Oversee team members and support personnel development to ensure essential job functions and duties are performed at high standards
    • Conduct performance reviews for team members
    • Participate in the recruitment, development, and performance management of staff 
    • Communicates and exemplifies Cook MyoSite Core Values

    Qualifications

    • Bachelor’s degree in scientific, education or teaching discipline or equivalent experience
    • Minimum of 3 years of relevant industry, Quality and/or GMP Training experience
    • Demonstrate managerial experience in Training and/or Quality
    • Must have experience developing and implementing training using an electronic learning management system
    • Experience interfacing with regulatory agencies
    • Must possess a thorough knowledge of GxP guidelines and regulations, ICH guidelines and regulatory compliance
    • Must possess excellent organizational skills, planning, scheduling, the ability to develop and the implement complex processes, procedures and systems

    • Demonstrate leadership, critical thinking and ability to develop departmental goals
    • High proficiency in MS Office and other general office equipment
    • Maintain composure and competence under stressful situations; flexibility and adaptability 
    • Ability to work in collaborative and independent work situations and environments with minimal supervision
    • Basic understanding of cGMP, 21 CFR Part 11, and related regulations associated with Bio/Pharmaceutical product manufacturing.

     

    Physical Requirements:

    • General office, warehouse and laboratory setting
    • Must be able to sit at desk, in meetings and/or work on a computer for long or extended periods of time
    • Ability to conduct and hear ordinary conversation and telephone communication
    • Visual and manual acuity for working with computers and equipment

    • Must be able to work extended hours beyond normal work schedule to include, but not limited to, evenings, weekends, extended work hours and/or extra work hours, sometimes on short notice as required
    • Ability to work under specific time constraints

     

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