GxP TRAINING SPECIALIST I - REMOTE

Join us in developing pioneering therapies that aim to transform the treatment of CKD and change patients’ lives. Our technology is designed to treat diseased kidneys using a patient’s own cells and may prevent or delay dialysis or transplant.

The GxP Training Specialist I is responsible for the support of Training within the QMS system in compliance with ProKidney Inc., SOP’s, and regulatory requirements from the FDA, EMA, and other applicable regulatory bodies. Responsibilities include managing company training records while also ensuring their accuracy, quality, and integrity.

Essential Duties & Responsibilities:

• Exemplifies the desired culture and philosophies of the organization: Transparency, Respect, Accountability, and Collaboration.
• Ensure training programs comply with regulatory requirements and industry standards.
• Ensure timely completion of training tasks, re-trainings and management of roles within the QMS based on overdue trainings.
• Complete pending Training Admin tasks within the QMS system including but not limited to: new/revised training configurations, verifying employee training, adding employee job codes and roles as assigned once training is complete, etc.  
• Assist with scheduling, coordinating and leading both in-person (conference room) and virtual training (MasterControl Classroom) sessions as needed.  
• Assist with incoming requests from other departments including but not limited to: training configuration updates, troubleshooting QMS issues, pulling training reports, etc.  
• Assist with user management tasks including but not limited to: adding job codes, verifying training and adding tasks as assigned, etc.  
• Collaborate with departments on creating appropriate training programs, course configurations, training materials, etc. to support their training efforts.
• Collaborate with process/document owners and stakeholders to prioritize, release, and implement quality system changes and updates to SOPs & Trainings.  
• Ensure record-keeping and documentation compliance with regulatory requirements.  
• Ensure timely coordination with document approvers, originators, and Document Control.
• Pull and analyze necessary training reports and needs assessment to provide support for deviations and CAPAs from a training perspective.
• Communicate training schedules and requirements to employees.
• Performs other duties and projects as assigned.

Computer Skills:

• Intermediate Proficiency in Microsoft products including Outlook, SharePoint, Word, PowerPoint, and Excel.
• Experience with MasterControl LMS or other LMS platforms.

Education And Experience:

Bachelor’s degree in Education, Training, Human Resources, or a related field and/or 0-2 years’ experience in a similar Training Administrative role in the biologics or pharmaceutical industry.

Knowledge, Skills, And Abilities

• Demonstrate understanding of cGMP, GCP, GDocP, and all other GxP applicable designations as well as the QMS.
• Ability to maintain positive cross-functional and collaborative relationships.
• Ability to maintain a positive attitude and ability to perform under pressure.
• Ability to exercise judgment within defined practices and policies in performing administrative training functions with input from supervisor as needed.
• Skills in maintaining and managing training records and data within the LMS, ensuring accuracy and compliance.
• Quality minded and ability to assist with process improvement efforts.
• Flexibility to adapt to changing priorities, technological advancements, and organizational needs related to training and LMS administration.
• Must be highly organized, able to prioritize tasks effectively and problem solve.
• Excellent verbal and written communication skills to effectively convey training information and provide support to users.

The position reports directly to the Manager of GxP Training.