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The Senior Training Specialist will assist in the execution of Training Management related to internal GMP operations at both the Gene Therapy Manufacturing Facility (GTMF) located in Bedford, MA and the Quality Control Laboratories located in Woburn, MA. This role will support training curricula design and deployment across the sites and support design and deployment of training materials to enhance learning and understanding of relevant GMP procedures and processes. This role will also support daily LMS administration tasks.
Work Model:Core Lab & Ops: This role typically requires that the majority of the work be conducted on-site.
Responsibilities:1. Execute Instructor Led Training activities for core cGMP concepts such as Good Documentation Practices, Data Integrity, and Quality Mindset. Develop and deliver periodic or focused training.
2. Support development of trainings and coordinate delivery of the training as applicable.
3. Execute the development of training curriculum to ensure consistency and effectiveness.
4. Support Quality System metrics to measure the health and effectiveness of training. Proactively identify, escalate, and address negative trends.
5. Support deviation investigations and CAPA planning that may require instructor-lead training
6. Daily monitoring and administrative tasks for Service Now tickets as they are related to Compliance Wire.
7. Organize and facilitate periodic review for New Hire Orientation training materials and present training to newly hired personnel.
8. Participate in audits/site inspections as the SME for training.
9. Support the Global Training (Quality System) teams to drive continuous improvement to the training processes
Requirements:1. Associate degree in Training, Biological Sciences, Biotechnology, Bachelor degree preferred or equivalent experience.
2. Minimum of 3-5 years working in a regulated environment (pharmaceutical, biotech, life sciences or healthcare) or equivalent experience/education.
3. Proficient in cGMP requirements and expectations.
4. Experience in training program administration
5. Proficiency with LMS platforms
6. Knowledge of regulatory training requirements and risk-based training approaches
7. Excellent communications skills, both written and verbal.
8. Excellent teamwork, interpersonal skills and negotiation skills, both internally and externally.
9. Creativity, energy and passion for training adults to improve understanding.
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The typical annual salary range for this full-time position is listed below. This range reflects the characteristics of the job, such as required skills and qualifications and is based on the office location noted in this job posting. The range may also be adjusted based on applicant's geographic location.
This position is eligible for annual bonus and equity incentives. Actual individual pay is determined by demonstrated experience and internal equity alignment.
Ultragenyx Pharmaceutical is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status, and any other status or classification protected by applicable federal, state, and/or local laws. Reasonable accommodation will be provided for all protected statuses or classifications protected by applicable law, including individuals with disabilities, disabled veterans, for pregnancy, childbirth, and related medical conditions, and based on sincerely held religious beliefs. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, you may contact Talent Acquisition by emailing us at [email protected].
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
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Ultragenyx Cambridge, Massachusetts, USA Office
840 Memorial Dr, Cambridge, MA, United States, 02139
Ultragenyx Waltham, Massachusetts, USA Office
303 Wyman St, Waltham, MA, United States, 02451
Ultragenyx Woburn, Massachusetts, USA Office
19 Presidential Way, Woburn, MA, United States, 01801
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