Job Title: Learning & Development SpecialistLocation: Devens, MAHours/Schedule: Mon - Fri, Business HoursType: ContractJoin a global biopharmaceutical company committed to discovering, developing and delivering innovative medicines to patients with serious illnesses.ResponsibilitiesKnowledge, Skills, and Abilities:Requires understanding of GMP manufacturing environments, processes and controls requirements.Intermediate sills in design, development, and implementation of training, utilizing ADDIE instructional design model.High level of experience delivering and assessing training.Advanced skills in using Microsoft Word, PowerPoint and Excel.Requires a high level of organizational and time management skills.Ability to communicate information clearly to facilitate effective learning.This position requires speaking in classroom settings.Requires strong interpersonal skills which enable appropriate collaboration with trainees, colleagues, and subject-matter experts.Ability to work in an aseptic environment requiring successful completion of qualification program.Education and Experience:Bachelor degree in Business or Education, B.S. in Biology, Biochemical, Chemical, or 3-5 years of relevant experience in a GMP manufacturing environment.RequirementsImplements training programs that meet regulatory requirements & business needs.Provide training expertise and consultation in support of the Devens site training model and process.Works with L&D and functional Subject Matter Experts to create a training and development plan to address production demands such that new hires become proficient operators and are contributing to processing stations in a timely fashion.Works with the Manager on an on-going basis to implement training goals and meet KPI’s.Conducts ILT and OJT sessions to support functional unit training requirements.Provides feedback to trainees to ensure all skills / knowledge have been acquired and communicates any skill/knowledge gaps that require additional training.Solicits feedback from trainees to ensure the appropriateness of course content, and for continuous improvement opportunities.Collaborates with the Manager to ensure training is compliant and effective.Maintains accurate training documentation and employee record keeping.Seeks feedback from Department Management to assess training needs and to identify areas for continuous improvement.Develops course content and procedures including new SOPs, TRNs for manufacturing training programs as necessary.Collaborates with L&D team and functional SMEs to identify trends which may require amendment to training programs.Develops / implements new course content as procedures change or as new techniques are introduced.Performs competency assessments of operators on an ongoing basis to ensure the knowledge/skills from training are continuously applied.Implements the local Manufacturing Operations new hire Training Program.Promotes and exhibit core Celgene values in onboarding and training activities.Performs administrative tasks such as scheduling training sessions, ordering training supplies, coordinating enrollment, and completing documentation.Communicates with different departments to ensure new hires have access to all necessary systems and security.Observe, practice, and promote all aspects of the GMP & GDP requirements.Collaborate with members of internal teams to drive process improvements and assist with implementation of changes by utilizing quality systems.Reports and initiates non-conformances and participates in follow up investigation when necessary.Performs all other duties as required.BenefitsSystem One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.#M3System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.