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Support Quality Associate Jobs in Virginia (NOW HIRING)

Krystal Biotech

Quality Assurance Associate

Moon, VA · On-site

Summary Krystal Biotech, Inc. is seeking a highly motivated and experienced Quality Associate to ... Provide support for updates on standard operating procedures and associated forms. * Assist with QA ...

Accelevation LLC

Quality Test Associate

Richmond, VA · On-site

Support continuous improvement initiatives related to product quality, testing effectiveness, and operational excellence Qualifications * High school diploma or equivalent required * Associate degree ...

L3HHCM20

Associate, Quality Engineer

Culpeper, VA · On-site

$56K - $104K/yr

Associate, Quality Engineer Job Code: 43982 Job Location: Orange, VA Job Schedule: 4/10s ... Employees work 10 hour days, 4 days a week L3Harris is seeking a new graduate to support quality ...

L3Harris

Associate, Quality Engineer

Orange, VA · On-site

$56K - $104K/yr

Job Title Associate, Quality Engineer Job Code 43982 Job Location Orange, VA Job Schedule 4/10s ... Employees work 10 hour days, 4 days a week L3Harris is seeking a new graduate to support quality ...

New

Andersen

Quality Inspector (3rd Shift, 4x10)

Luray, VA

$20.25 - $24.29/hr

The Quality Inspector supports this goal by first performing defined audits of product and ... The audits also identify specific discussion topics the Quality Associate can review with the ...

Adecco

Quality Assistant

Richmond, VA · On-site

$19/hr

... and support team Apply today and join a team dedicated to quality, safety, and operational excellence. Pay Details: $19.00 per hour Benefit offerings available for our associates include medical ...

Adecco

Quality Assistant

Richmond, VA · On-site

$19/hr

... and support team Apply today and join a team dedicated to quality, safety, and operational excellence. Pay Details: $19.00 per hour Benefit offerings available for our associates include medical ...

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Quality Assurance Associate

Moon, VA • On-site

Krystal Biotech
Biotechnology Research and Development • 51 - 200 employees
Learn more about Krystal Biotechexternal

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Posted 13 days ago

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 Astra manufacturing facility in Moon Township, PA.

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 ishighly 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.

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