Position Summary:

ultrafocused – Work together to fearlessly uncover new possibilities

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:

• 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.
• Support development of trainings and coordinate delivery of the training as applicable.
• Execute the development of training curriculum to ensure consistency and effectiveness.
• Support Quality System metrics to measure the health and effectiveness of training. Proactively identify, escalate, and address negative trends.
• Support deviation investigations and CAPA planning that may require instructor-lead training
• Daily monitoring and administrative tasks for Service Now tickets as they are related to Compliance Wire.
• Organize and facilitate periodic review for New Hire Orientation training materials and present training to newly hired personnel.
• Participate in audits/site inspections as the SME for training.
• Support the Global Training (Quality System) teams to drive continuous improvement to the training processes

Requirements:

• Associate degree in Training, Biological Sciences, Biotechnology, Bachelor degree preferred or equivalent experience.
• Minimum of 3-5 years working in a regulated environment (pharmaceutical, biotech, life sciences or healthcare) or equivalent experience/education.
• Proficient in cGMP requirements and expectations.
• Experience in training program administration
• Proficiency with LMS platforms (Compliance Wire, Veeva, etc.)
• Knowledge of regulatory training requirements and risk-based training approaches
• Excellent communications skills, both written and verbal.
• Excellent teamwork, interpersonal skills and negotiation skills, both internally and externally.
• Creativity, energy and passion for training adults to improve understanding.

Non Manufacturing or Lab Job Physical Demands/Work Environment/Safety Considerations:

• Stand for extended periods of time with periodic stooping / bending / kneeling.
• Able to lift, push, pull up to 50lbs.
• Climb ladders and stairs of various heights.
• Work in a controlled environment requiring GxP gowning and wear protective clothing over the head, face, hands, feet, and body. This requires the ability to change clothes into appropriate gowning and personal protective equipment.
• Certain tasks may require the use of a respirator; medical clearance will be required in advance.
• Must remove all make-up, jewelry, and contact lenses while in the manufacturing environment.
• Working in temperature-controlled environments (cold rooms).

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