Quality Assurance Associate Job at Krystal Biotech, Pittsburgh, PA

UzhGQWpvbkd0Y2ZtNStXVzZVb1ZvV3BmZFE9PQ==
  • Krystal Biotech
  • Pittsburgh, PA

Job Description

Job Description

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 experienced Quality Associate to support quality systems, GMP manufacturing processes and documentation practices at our headquarters in Pittsburgh's South Side.

Primary Responsibilities:
  • Work with internal teams to obtain an understanding of the product and the documentation requirements.
  • Produce high-quality documentation that meets applicable standards and is appropriate for its intended use.
  • Develop expertise on FDA regulations and audit processes.
  • Initiate and update GMP manufacturing associated documentation, such as clearing procedures.
  • Provide oversight of daily QA functions which include review and approval of records generated by manufacturing and quality control documents.
  • Provide support for updates on standard operating procedures and associated forms.
  • Assist with QA efforts for site cGXP documentation related to the operation of gene therapy manufacturing.
  • Ensure compliance with regulatory agencies and oversee continuous improvement of company's QA and compliance functions.
Requirements & Desired Competencies:
  • Minimum of a Bachelor’s Degree (Biology or related Life Science) with 3+ years of relevant quality systems experience in the biotech or pharmaceutical industry.
  • Background that includes knowledge/experience in GMP, GLP, and GCP.
  • Experience with FDA audits is highly preferred.
  • Strong knowledge of GMP and ICH requirements.
  • Must be a self-starter and capable of working with minimal oversight.
  • Must be able to handle multiple roles and work in a fast paced and changing environment and know how to prioritize activities appropriately.
  • Excellent oral and written communication 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.


 

Powered by JazzHR

1iJTok9vom

Job Tags

Similar Jobs

Verizon

Head of Media Relations Job at Verizon

 ...and empower how people live, work and play by connecting them to...  ...Join the V Team Life. The Media Relations Senior Manager will...  ...-of-the-box public relations, social media and integrated marketing...  ...location that includes work from home and a minimum eight assigned office... 

Laderach USA

Senior Marketing Manager Job at Laderach USA

 ...while addressing regional market needs. The Senior Marketing Manager will collaborate closely with the global marketing team in Switzerland, ensuring consistency in messaging and brand positioning. This role offers an exciting opportunity to shape Lderach s brand presence... 

BAYADA Home Health Care

Pediatric Licensed Practical Nurse (LPN) Job at BAYADA Home Health Care

 ...for success : Paid training from day 1 in the office, in the home, and online Practice with award-winning adult and pediatric Simulation labs Around the clock clinical support by phone Electronic charting using AlayaCare We care for clients... 

The Medical Transcription Service

Work From Home as a Medical Transcriptionist Job at The Medical Transcription Service

We are looking for good pathology MTs who can work evenings. Must reside in the U.S. or Canada. Our MTs are independent contractors working from home. For more information regarding earning potential, equipment needed, and the reports we transcribe. Please email us for ...

Horizon Services

HVAC Service Technician - MUST Have HVAC Journeyman's License Job at Horizon Services

 ...Job Description Title: HVAC Technician up to $40/hr. base pay $3000 Sign-on Bonus HVAC Technician - Are you an HVAC Service expert who is passionate about problem solving and customer service? Looking to accelerate your career (and income!) with an organization...