Quality Assurance Document Control Associate

Job Description Summary

Krystal Biotech, Inc is seeking a highly motivated and dynamic Quality Assurance Document Control Associate to support the implementation of our quality and document control systems. The primary focus of this role is to support the implementation of our quality and document control systems. The Associate will work cross-functionally to ensure compliance with all internal procedures, cGMP's, and regulatory requirements within the GMP manufacturing area and Quality Control laboratory. The Associate will perform administrative assistant duties for the Astra location.

Responsibilities

• General office organization and maintenance
• Keeping the conference rooms, office and kitchen areas cleaned and stocked
• Office supply ordering and tracking for the Astra location
• Coordination of conference room bookings
• Greet all visitors and ensure company sign-in policy is followed and/or answer the visitor arrival phone when applicable
• Ensure coverage is available for the front desk during all breaks
• Assist with shipping and receiving as required
• Review, process and distribute controlled documents, such as SOPs, protocols, and other technical documents while adhering to specific format standards and guidelines
• Ensure accurate documentation and record keeping at all times
• Continuously monitor that limited access restrictions are enforced for secure and controlled documents
• Assist with data entry and administrative tasks to support access control for the Astra location as well as maintain the log for access logins
• Support controlled document life cycle/retention procedures
• Manages records retention/archiving, while adhering to specific records retention schedules
• Supports with internal and external audits and regulatory inspections, to include retrieval of GMP documentation
• Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules
• Maintains an awareness of evolving industry standards for document generation and electronic document management
• Maintains Document Control Room(s) in an inspection ready state
• Ensures all paperwork is distributed, reconciled, archived, and filed in a timely manner
• Other duties as assigned

Requirements and Preferred Qualifications

• Bachelor's degree preferred, or equivalent combination of education and professional experience
• Knowledge of FDA regulations and industry standard guidelines for electronic records, highly preferred
• Ability to maintain confidentiality and work with sensitive documents
• 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
• Excellent interpersonal, collaboration and stakeholder management skills
• Excellent communication skills (written/verbal)