Quality Assurance Document Control Associate

Krystal Biotech; United States; On-site; USD 60,000 - 80,000; Full time

Job summary

Krystal Biotech, Inc. seeks a highly organized Quality Assurance Document Control Associate to support GMP manufacturing and QC laboratories. You will manage controlled documents, maintain audit-ready records, and help ensure regulatory compliance across Astra location.

Responsibilities include coordinating document life cycle, supporting internal/external audits, and maintaining confidentiality while working cross-functionally with quality, manufacturing, and QA teams to uphold cGMP standards.

Qualifications

• Bachelor's degree or equivalent experience.
• Knowledge of FDA regulations and electronic records.
• Ability to maintain confidentiality with sensitive documents.
• Highly organized and detail oriented with strong synthesis.
• Proactive, flexible, able to meet deadlines under pressure.
• Excellent interpersonal and communication skills.

Responsibilities

• General office organization and maintenance.
• Review, process and distribute controlled documents, such as SOPs and protocols.
• Ensure documentation and record keeping are accurate and audit-ready.
• Maintain restricted access controls for controlled documents.
• Assist with data entry and access control logs at the Astra location.
• Support document lifecycle/retention procedures and archiving.
• Assist audits and regulatory inspections, retrieving GMP docs.
• Maintain document control rooms in inspection-ready state.
• Perform other duties as assigned.

Skills

Attention to detail

Organizational skills

Regulatory knowledge

Communication skills

Confidentiality

Education

Bachelor's degree or equivalent

Job description

About 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.

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)

Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, or disability status. Headhunters and recruitment agencies may not submit resumes/CVs through this Web site or directly to managers. Krystal Biotech, Inc. does not accept unsolicited headhunter and agency resumes. Krystal Biotech, Inc. will not pay fees to any third-party agency or company that does not have a signed agreement with Krystal Biotech, Inc. #LI-CF1