Clinical Quality Assurance Specialist

United States·Pittsburghmid

Quality Assurance SpecialistLaboratory & Life Sciences

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Quick Summary

Key Responsibilities

Receive, organize, and manage essential clinical trial documents to ensure compliance with regulations and internal SOPs/plans.

Requirements Summary

BS/BA in Life Sciences or related field. 2+ years’ relevant experience in healthcare, biotech or pharmaceutical industry Knowledge of GCP guidelines, FDA regulations,

Technical Tools

Quality Assurance SpecialistLaboratory & Life Sciences

Trial Master File and Clinical Quality Assurance Specialist

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 Clinical Quality Assurance and Trial Master File (TMF) Specialist to support the management of essential clinical trial documents and clinical quality systems.

Primary Responsibilities:

Receive, organize, and manage essential clinical trial documents to ensure compliance with regulations and internal SOPs/plans.
Review and upload trial documents to electronic TMF system and track document status.
Assist in conducting quality checks on trial artifacts for completeness, accuracy, and timeliness
Support study teams to resolve essential document discrepancies.
Collaborate with study staff and TMF managers to ensure the TMF is inspection-ready.
Assist in the development and maintenance of clinical quality systems.
Support internal and regulatory inspections.
Conduct GCP audits (e.g., vendor, study, and internal process audits) to ensure compliance with applicable GCP/regulatory requirements and policies/procedures.
Assist in the development of corrective and preventive action plans and in the assessment of their effectiveness.
Participate in risk assessment of clinical trial protocols.
Other duties as assigned

Requirements and Preferred Qualifications:

BS/BA in Life Sciences or related field.
2+ years’ relevant experience in healthcare, biotech or pharmaceutical industry
Knowledge of GCP guidelines, FDA regulations, and TMF reference model
Proficiency with electronic TMF platforms (Veeva Vault), desired
Strong knowledge of clinical study documents
Excellent organizational skills

Krystal Biotech, Inc. is an Equal Employment Opportunity and Affirmative Action Employers. 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.