Position Summary & Role
This role is accountable for supporting the development, implementation, and maintenance of a compliant and effective GMP training program at the Marlborough manufacturing plant. This is an exciting opportunity to support the establishment of a training program for a brand new GMP facility, and this role will play a fundamental part in the on-boarding of each new employee. The use of technology platforms and innovative learning techniques will be encouraged to improve employee experience and training effectiveness at this highly digital factory. The GMP Training Sr. Specialist is a key quality system support function across the site and reports to the Head of Quality Systems & Compliance. The position will be located in Marlborough, MA.
Ensures quality activities are carried out according to regulatory and quality requirements.
Supports the development and implementation of site training procedures and processes and ensures alignment with Global network standards and procedures.
Develops competency-based training, utilizing instructional design model and adult learning principles. This includes training in the areas of general and advanced knowledge of current regulations, functional job knowledge and skill development.
Collaborates with management at the site to develop and manage personnel training plans in alignment with learning objectives and employee’s functional role.
Assists Managers in developing on-the-job (OJT) training curricula, task assessments and instructor led courses.
Manages and maintains training curricula, training records and monitors training/re-training requirements using the Resilience LMS.
Acts as a technical system expert and supports, manages, and monitors the global EDMS and the ELMS (Veeva).
Coordinates, schedules, and conducts GMP training sessions.
Supports New Hire orientation activities.
Participates in applicable network communities of practices and shares best practices across the network as well as lead and/or support site and network initiatives.
Responsible for monitoring and reporting system health metrics for training compliance and accountable for ensuring corrective actions and/or improvements plans are properly documented and executed.
Provides support in the preparation for, conduct of, and follow-up activities associated with regulatory inspections and client audits.
Preferred Experience, Education & Qualifications (Education/Degrees/Certifications)
Bachelor’s degree or higher in Instructional Design, Life Sciences or a related field
Minimum of 5 years working with GMP documentation and processes
Hands-on experience with developing GMP training content
Comprehensive knowledge of global GMP regulatory requirements for training
Experience developing OJT training material and qualification programs for tasks
Ability to aseptically gown and deliver GMP training within clean zones
Other Ideal Personal Characteristics:
Proven record of cross-functional and matrix team leadership
Experience with delivering presentations, facilitation and teaching to diverse audiences
Desire and interest to leverage new technology and innovative learning techniques
Ability to collaborate and manage conflict in a fast-pace environment, working across functions
Excellent interpersonal, verbal and written communication skills
Experience in application of lean methodologies and operational excellence to continuously improve
ManpowerGroup is committed to providing equal employment opportunities in a professional, high quality work environment. It is the policy of ManpowerGroup and all of its subsidiaries to recruit, train, promote, transfer, pay and take all employment actions without regard to an employee’s race, color, national origin, ancestry, sex, sexual orientation, gender identity, genetic information, religion, age, disability, protected veteran status, or any other basis protected by applicable law.
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