GMP Laboratory Systems Associate

GMP Laboratory Systems Associate

About Krystal Bio:

At Krystal Biotech, Inc., we bring together the brightest and most eager minds to relentlessly pursue the discovery, development and delivery of transformative medicines for people with serious and life-threatening genetic diseases. Founded in 2016, the Company is the leader in redosable gene therapy with prominent clinical and pre-clinical stage programs for dystrophic epidermolysis bullosa, TGM1-deficient ARCI, Netherton Syndrome, Cystic Fibrosis, alpha-1 antitrypsin deficiency, and is advancing research to apply our technology to these and other diseases. The Company's innovation is fueled by visionary leadership within an entrepreneurial organizational structure with a robust pipeline of investigational medicine.

Our US headquarters is in Pittsburgh, PA with other offices located in Boston, MA and in Zug, Switzerland. For more information about the Company's platform, commitment to patients and pipeline, please visit http://www.krystalbio.com and engage with us on Twitter and LinkedIn.

We have an exciting journey ahead and a tremendous opportunity for growth, and now is the time to make a meaningful impact on the lives of our patients!

Job Description Summary:

Krystal Biotech, Inc is seeking a highly motivated Laboratory Systems Associate who will work under the direction of the Quality Systems Manager. The Associate will support the development of Laboratory & Quality Systems (LIMS, QMS, and DMS), as well as assisting lab personnel with troubleshooting and software issues.

Responsibilities will include, but are not limited to, the following:

• Works with end users to develop and implement the Quality Systems
• Interact with internal departments to provide user support for the Quality Systems and to resolve complex issues in a timely manner
• Works to ensure the quality electronic systems are audit ready and follow the applicable guidelines (SOX, GMP, GXP)
• Write Installation, Operational and Performance Qualifications for electronic systems
• Understands and participates in corrective or preventative actions and be able to improve systems and procedures as applicable
• Must be able to work in a fast-paced environment and be able to prioritize tasks appropriately
• Participates in computer system validation of electronic systems and any GMP equipment software
• Other duties as assigned

Requirements and Preferred Qualifications:

• Bachelor's degree (Information Technology, Life Sciences or Engineering) with 1+ years of relevant experience, preferably in a biotech or pharmaceutical setting
• Background that includes knowledge/experience of GMP, GLP, GCP, and/or USP requirements, CSV, and Software IQ/OQ/PQ
• Strong technical and troubleshooting skills
• Experience with the Salesforce Platform highly preferred
• Excellent writing and editing as well as written/oral communication skills are required
• Ability to work in a fast-paced changing environment in conjunction with the quality team and know how to prioritize activities appropriately
• Must be a self-starter and capable of working with minimal oversight
• Must be detail oriented and conscientious. Ability to understand and follow written procedures

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.