Quality Assurance Training Coordinator

Krystal Biotech•Pittsburgh, PA

About The Position

Krystal Bio: At Krystal Biotech, we bring together the brightest and most eager minds to relentlessly pursue the discovery, development, manufacturing, and commercialization of genetic medicines to treat diseases with high unmet medical needs. Founded in 2016, Krystal is distinguished in three powerful ways: science and technology using our patented gene therapy platform, innovative manufacturing supported by our commercial scale facilities, and a unique commercialization model that focuses on the patient’s end-to-end experience. Krystal received U.S. FDA approval for the first and only redosable gene therapy treatment, VYJUVEK®, for the treatment of Dystrophic Epidermolysis Bullosa (DEB). Krystal continues to leverage our proprietary platform to rapidly advance a robust pipeline of investigational genetic medicines in respiratory, oncology, dermatology, and ophthalmology. Krystal is headquartered in Pittsburgh, PA, which is home to our two state-of-the-art CGMP manufacturing facilities with teams around the world and satellite offices in Switzerland, Germany, and Japan. We are a company built and run by people who care, are fearless in the face of a challenge, love the work they do, and practice the highest level of scientific integrity. As we grow, we are seeking team members that embody these values.

Requirements

Bachelor’s degree, preferably in life sciences or technical field, or equivalent combination of education and relevant experience
2+ years of professional experience in a training or developmental capacity.
Experience within biopharmaceutical industry is highly preferred along with a demonstrated understanding of cGXP’s
Highly organized and detail oriented, while also demonstrating the ability to synthesize information and demonstrate strategic thinking
Highly self-motivated, flexible, proactive, able to follow through in an ambiguous, fast-changing environment, and proven ability to meet deadlines under pressure
Demonstrated ability to prioritize and manage multiple projects simultaneously
Demonstrated ability to work effectively with many different types of personalities at all levels of the organization
Excellent interpersonal, collaborative and stakeholder management skills
Excellent communication skills (written/verbal)

Nice To Haves

Experience in an electronic training system such as Veeva Training Vault preferred.

Responsibilities

Administer and maintain the GMP program and Learning Management System; experience with Veeva is preferred but not required.
Maintain up-to-date knowledge on all applicable regulatory guidelines and regulations, and develop training programs to ensure employees are equipped to succeed on cGMPs and other regulations.
Participate in compliance evaluation of regulated activities within pharmaceutical development and cGMP manufacturing.
Develop and update GMP training materials for new-hires, existing employees, contractors and visitors; assist with group training.
Coordinate and/or provide annual GMP and GDP training.
Administer training program schedules on standard operating procedures (SOPs), GMP concepts and organizational policies, when required.
Manage employee training program and maintain metrics/reports; review all training files periodically.
Assign and track required training based on employee roles, curricula, job functions, and departmental requirements. Monitor training completion and overdue training and communicate/escalate as appropriate.
Inform management of deviations from regulations and cGMP and assist in determining appropriate solutions while verifying that assigned actions have been implemented.
Collaborate with Quality Assurance, Manufacturing, Quality Control, Facilities, Supply Chain and other functions.
Maintain employee training records and ensure training documentation is complete, accurate, attributable, and readily retrievable.
Participate in learning and training to be competent in above functions.
Generate and review training metrics, including overdue training and on-time completion.
Support investigations and CAPAs related to training deficiencies or training-system issues.
Assist with periodic review of training curricula and employee training assignments to ensure continued appropriateness.
Support inspection readiness by retrieving training records and responding to training-related documentation requests, as well as acting as SME for training during inspections.
Other duties as assigned