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Krystal Biotech
Moon, PA | Full Time
$83k-101k (estimate)
1 Month Ago
Quality Assurance Associate
$83k-101k (estimate)
Full Time | Scientific Services 1 Month Ago
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Krystal Biotech is Hiring a Quality Assurance Associate Near Moon, PA

Quality Assurance Associate About Krystal Bio:At Krystal Biotech, Inc., we bring together the brightest and most eager minds to relentlessly pursue the discovery, development and commercialization of gene delivery medicines for patients with serious and life-threatening genetic diseases. Founded in 2016, Krystal is a leader in gene therapy. Krystal received U.S. FDA approval for the first-ever redosable gene therapy treatment, VYJUVEK™, for the treatment of Dystrophic Epidermolysis Bullosa. Krystal continues to leverage our proprietary platform to develop new treatments across a robust clinical pipeline. Located near Krystal’s headquarters are two state-of-the-art GMP facilities.Krystal Biotech is based in Pittsburgh, PA which is home to our two state-of-the-art GMP facilities. Additional offices are situated in Boston, MA and in Zug, Switzerland. Join us on our journey to implement our mission to identify, develop and deliver genetic medicines to patents!Job Description Summary:Krystal Biotech, Inc. is seeking a highly motivated and experienced Quality Associate to support quality systems, GMP manacturing processes and documentation practices through the expansion of our new, state-of-the art GMP facility in Moon Township.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.
  • 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.
  • 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.

Job Summary

JOB TYPE

Full Time

INDUSTRY

Scientific Services

SALARY

$83k-101k (estimate)

POST DATE

03/22/2024

EXPIRATION DATE

06/18/2024

WEBSITE

krystalbio.com

HEADQUARTERS

SAN FRANCISCO, CA

SIZE

50 - 100

FOUNDED

2016

CEO

SUMA KRISHNAN

REVENUE

<$5M

INDUSTRY

Scientific Services

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The job skills required for Quality Assurance Associate include Quality Assurance, Quality Control, Written Communication, Continuous Improvement, Standard Operating Procedures, etc. Having related job skills and expertise will give you an advantage when applying to be a Quality Assurance Associate. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Quality Assurance Associate. Select any job title you are interested in and start to search job requirements.

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The following is the career advancement route for Quality Assurance Associate positions, which can be used as a reference in future career path planning. As a Quality Assurance Associate, it can be promoted into senior positions as a Quality Assurance Specialist IV that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Quality Assurance Associate. You can explore the career advancement for a Quality Assurance Associate below and select your interested title to get hiring information.

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If you are interested in becoming a Quality Assurance Associate, you need to understand the job requirements and the detailed related responsibilities. Of course, a good educational background and an applicable major will also help in job hunting. Below are some tips on how to become a Quality Assurance Associate for your reference.

Step 1: Understand the job description and responsibilities of an Accountant.

Quotes from people on Quality Assurance Associate job description and responsibilities

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Train and provide assistance to less experienced members of the QA team on quality procedures, protocols, and documentation.

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Step 2: Knowing the best tips for becoming an Accountant can help you explore the needs of the position and prepare for the job-related knowledge well ahead of time.

Career tips from people on Quality Assurance Associate jobs

Quality Assurance Specialist roles will typically be looking for the skills previously outlined.

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