8 Jobs in Pittsburgh, PA
Krystal Biotech is Hiring a Clinical Quality Assurance Specialist Near Pittsburgh, PA
Krystal Biotech is based in Pittsburgh, PA which is home to our two state-of-the-art GMP facilities.
Join us on our journey to implement our mission to identify, develop and deliver genetic medicines to patients!
Job Description Summary:Krystal Biotech, Inc is seeking a highly motivated Clinical Quality Assurance Specialist to provide oversight and support of various clinical trials, ensuring robust compliance across all applicable regulations.
Specific responsibilities include but are not limited to:
- Develop and maintain robust quality systems
- Establish and maintain effective strategies, systems and procedures, ensuring compliance with applicable GCP standards
- Ensure that all processes contributing to the performance of a clinical trial are conducted properly
- Author/review summary reports, memos and standard operating procedures
- Support internal and regulatory inspections
- Support audited groups in developing effective, risk based corrective actions
- Coordinate, conduct, and/or oversee GCP audits (e.g., vendor, clinical investigator site, internal audits) to ensure compliance with applicable GCP/regulatory requirements and guidelines, study protocols, monitoring plans and applicable policies/procedures
- Assist in remediation and corrective action plans to ensure all parts of the study are conducted properly and in compliance
- Partner with key customer groups in clinical Operations to develop and meet quality objectives
- Evaluate and improve existing processes with limited guidance
- Maintain on the job knowledge and skills by participating in applicable training
- Other duties as assigned
- BS/BA in Life Sciences or related field
- 5 years’ relevant experience in healthcare, biotech or pharmaceutical industry
- Qualified auditor experience is highly preferred
- Working knowledge of GCP regulations/ guidelines (ICH, US FDA, ISO)
- Clinical Research Certification, desired
- Strong computer skills
- Excellent communication (verbal and written) skills and ability to work effectively on teams
- Excellent organizational skills
- Ability to travel
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Job Summary
Full Time
Scientific Services
$93k-112k (estimate)
06/08/2024
07/06/2024
krystalbio.com
SAN FRANCISCO, CA
50 - 100
2016
SUMA KRISHNAN
<$5M
Scientific Services
Related Companies
The job skills required for Clinical Quality Assurance Specialist include Quality Assurance, ISO, Internal Audit, Standard Operating Procedures, Verbal Communication, etc. Having related job skills and expertise will give you an advantage when applying to be a Clinical Quality Assurance Specialist. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Clinical Quality Assurance Specialist. Select any job title you are interested in and start to search job requirements.
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