At Krystal Biotech, we bring together the brightest and most eager minds to relentlessly pursue the ... Provide oversight of daily QA functions which include review and approval of records generated by ...
At Krystal Biotech, we bring together the brightest and most eager minds to relentlessly pursue the ... Provide oversight of daily QA functions which include review and approval of records generated by ...
At Krystal Biotech, we bring together the brightest and most eager minds to relentlessly pursue the ... Provide oversight of daily QA functions which include review and approval of records generated by ...
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At Krystal Biotech, we bring together the brightest and most eager minds to relentlessly pursue the ... Provide oversight of daily QA functions which include review and approval of records generated by ...
Apply Early
At Krystal Biotech, we bring together the brightest and most eager minds to relentlessly pursue the ... Provide oversight of daily QA functions which include review and approval of records generated by ...
At Krystal Biotech, we bring together the brightest and most eager minds to relentlessly pursue the ... Provide oversight of daily QA functions which include review and approval of records generated by ...
At Krystal Biotech, we bring together the brightest and most eager minds to relentlessly pursue the ... Provide oversight of daily QA functions which include review and approval of records generated by ...
Quick apply
At Krystal Biotech, we bring together the brightest and most eager minds to relentlessly pursue the ... Provide oversight of daily QA functions which include review and approval of records generated by ...
Our client, a world leader in biotechnology and life sciences, is seeking a " QA Specialist (Biotech / Pharmaceutical manufacturing) . Location: Oceanside, CA Duration: Long-Term Contract ...
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Our client, a world leader in biotechnology and life sciences, is seeking a " QA Specialist (Biotech / Pharmaceutical manufacturing) . Location: Oceanside, CA Duration: Long-Term Contract ...
QA Associate
$85K - $115K/yr
PSC Biotech provides the life sciences with essential services to ensure that health care products ... Your Role We are seeking a QA Associate to support calibration and maintenance activities within a ...
QA Associate
$85K - $115K/yr
PSC Biotech provides the life sciences with essential services to ensure that health care products ... Your Role We are seeking a QA Associate to support calibration and maintenance activities within a ...
QA Investigations Lead II
Raritan, NJ · On-site
Legend Biotech entered into a global collaboration agreement with Janssen, one of the ... Role Overview The QA Investigation Lead is an exempt level position reporting to the QA ...
QA Investigations Lead II
Raritan, NJ · On-site
Legend Biotech entered into a global collaboration agreement with Janssen, one of the ... Role Overview The QA Investigation Lead is an exempt level position reporting to the QA ...
Quality Assurance Manager
Chamblee, GA · On-site
Who is CorDx CorDx a multi-national biotech organization focused on pushing the limits of ... We are seeking an experienced Quality Assurance Manager to lead our quality assurance team in the ...
Quality Assurance Manager
Chamblee, GA · On-site
Who is CorDx CorDx a multi-national biotech organization focused on pushing the limits of ... We are seeking an experienced Quality Assurance Manager to lead our quality assurance team in the ...
Quality Assurance Engineer
Rochester, NY · On-site
New York Duration : Long Term Position Overview We are seeking an experienced Quality Assurance Engineer to support quality assurance activities within a pharmaceutical, biotechnology, or medical ...
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Quality Assurance Engineer
Rochester, NY · On-site
New York Duration : Long Term Position Overview We are seeking an experienced Quality Assurance Engineer to support quality assurance activities within a pharmaceutical, biotechnology, or medical ...
Quality Assurance Manager
Chamblee, GA · On-site
Who is CorDx? CorDx a multi-national biotech organization focused on pushing the limits of ... We are seeking an experienced Quality Assurance Manager to lead our quality assurance team in the ...
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Apply Early
Quality Assurance Manager
Chamblee, GA · On-site
Who is CorDx? CorDx a multi-national biotech organization focused on pushing the limits of ... We are seeking an experienced Quality Assurance Manager to lead our quality assurance team in the ...
Apply Early
Quality Assurance Manager
Alpharetta, GA · On-site
Who is CorDx? CorDx a multi-national biotech organization focused on pushing the limits of ... We are seeking an experienced Quality Assurance Manager to lead our quality assurance team in the ...
Quality Assurance Manager
Alpharetta, GA · On-site
Who is CorDx? CorDx a multi-national biotech organization focused on pushing the limits of ... We are seeking an experienced Quality Assurance Manager to lead our quality assurance team in the ...
Quality Assurance Manager
Alpharetta, GA · On-site
Who is CorDx CorDx a multi-national biotech organization focused on pushing the limits of ... We are seeking an experienced Quality Assurance Manager to lead our quality assurance team in the ...
Quality Assurance Manager
Alpharetta, GA · On-site
Who is CorDx CorDx a multi-national biotech organization focused on pushing the limits of ... We are seeking an experienced Quality Assurance Manager to lead our quality assurance team in the ...
Quality Assurance Manager
Alpharetta, GA · On-site
Who is CorDx? CorDx a multi-national biotech organization focused on pushing the limits of ... We are seeking an experienced Quality Assurance Manager to lead our quality assurance team in the ...
Quick apply
Apply Early
Quality Assurance Manager
Alpharetta, GA · On-site
Who is CorDx? CorDx a multi-national biotech organization focused on pushing the limits of ... We are seeking an experienced Quality Assurance Manager to lead our quality assurance team in the ...
Apply Early
Director, GMP QA Operations -- Biotech Quality Leader (Waltham)
Waltham, MA · On-site
$188K - $230K/yr
A biotechnology company in Waltham, MA is seeking a Director of QA GMP Operations responsible for managing GMP quality within external manufacturing and internal operations. The ideal candidate will ...
Director, GMP QA Operations -- Biotech Quality Leader (Waltham)
Waltham, MA · On-site
$188K - $230K/yr
A biotechnology company in Waltham, MA is seeking a Director of QA GMP Operations responsible for managing GMP quality within external manufacturing and internal operations. The ideal candidate will ...
Legend Biotech entered into a global collaboration agreement with Janssen, one of the ... Role Overview The QA Lab Compliance (QALC) specialist III role is an exempt level position with ...
Legend Biotech entered into a global collaboration agreement with Janssen, one of the ... Role Overview The QA Lab Compliance (QALC) specialist III role is an exempt level position with ...
Quality Assurance Specialist Location: Indianapolis, IN Duration: Long Term Job Summary We are ... biotech environment. The ideal candidate will be responsible for drafting, reviewing, negotiating ...
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Quality Assurance Specialist Location: Indianapolis, IN Duration: Long Term Job Summary We are ... biotech environment. The ideal candidate will be responsible for drafting, reviewing, negotiating ...
QA Associate
Irvine, CA · On-site
$85K - $115K/yr
PSC Biotech provides the life sciences with essential services to ensure that health care products ... Your Role We are seeking a QA Associate to support calibration and maintenance activities within a ...
QA Associate
Irvine, CA · On-site
$85K - $115K/yr
PSC Biotech provides the life sciences with essential services to ensure that health care products ... Your Role We are seeking a QA Associate to support calibration and maintenance activities within a ...
QA Associate
$85K - $115K/yr
PSC Biotech provides the life sciences with essential services to ensure that health care products ... Your Role We are seeking a QA Associate to support calibration and maintenance activities within a ...
Quick apply
Apply Early
QA Associate
$85K - $115K/yr
PSC Biotech provides the life sciences with essential services to ensure that health care products ... Your Role We are seeking a QA Associate to support calibration and maintenance activities within a ...
Apply Early
QA Shop Floor Specialist II
Raritan, NJ · On-site
Legend Biotech is seeking a QA Shop Floor Specialist as part of the Quality Operations team based in Raritan, New Jersey. Role Overview The QA Shop Floor Specialist is an exempt level position ...
QA Shop Floor Specialist II
Raritan, NJ · On-site
Legend Biotech is seeking a QA Shop Floor Specialist as part of the Quality Operations team based in Raritan, New Jersey. Role Overview The QA Shop Floor Specialist is an exempt level position ...
Peregrine Team is hiring a Quality Assurance Specialist to support a growing biotech organization focused on developing and manufacturing innovative therapies. This role will play a key part in ...
Peregrine Team is hiring a Quality Assurance Specialist to support a growing biotech organization focused on developing and manufacturing innovative therapies. This role will play a key part in ...
Quality Assurance Biotech information
See salary details
$12.98 - $17.44
17% of jobs
$18.91 is the 25th percentile. Wages below this are outliers.
$17.44 - $21.90
24% of jobs
The median wage is $24.13 / hr.
$21.90 - $26.35
18% of jobs
$26.35 - $30.81
15% of jobs
$31.18 is the 75th percentile. Wages above this are outliers.
$30.81 - $35.27
10% of jobs
$35.27 - $39.73
8% of jobs
$39.73 - $44.19
5% of jobs
$44.19 - $48.65
3% of jobs
$48.65 - $53.10
0% of jobs
$53.10 - $57.56
0% of jobs
$57.56 - $62.02
0% of jobs
$12
$29
$62
How much do quality assurance biotech jobs pay per hour?
What is a Quality Assurance Biotech job?
A Quality Assurance (QA) Biotech job involves ensuring that biotechnology products meet regulatory and company standards for safety, efficacy, and quality. QA professionals develop and implement quality systems, conduct audits, review documentation, and ensure compliance with Good Manufacturing Practices (GMP) and other regulations. They collaborate with various departments, including manufacturing, R&D, and regulatory affairs, to maintain product integrity. Their role is critical in preventing defects, ensuring consistent processes, and maintaining compliance with industry standards.
What are the key skills and qualifications needed to thrive in the Quality Assurance Biotech position, and why are they important?
To thrive as a Quality Assurance Biotech, you need a solid understanding of biotechnology processes, quality control methodologies, and regulatory standards such as GMP, often supported by a degree in biology, chemistry, or a related field. Familiarity with laboratory information management systems (LIMS), documentation software, and industry certifications like ASQ or GMP training is highly beneficial. Attention to detail, strong analytical thinking, and effective communication skills are valued soft skills in this role. These abilities ensure precise compliance with regulatory requirements, facilitate collaboration with cross-functional teams, and help maintain the integrity and safety of biotech products.
What are the most common challenges faced by Quality Assurance professionals in the biotech industry?
Quality Assurance professionals in biotechnology often encounter challenges related to staying up-to-date with evolving regulatory requirements and ensuring that all processes consistently meet strict quality standards. Additionally, managing thorough documentation and collaborating across various departments—such as research, manufacturing, and regulatory affairs—can be complex. Those in the role may also need to respond quickly to deviations or quality events, requiring both proactive problem-solving and excellent organizational skills. However, overcoming these challenges is highly rewarding, as it directly contributes to maintaining the safety and efficacy of biotech products.

Job description
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.
- 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.
About Krystal Biotech
Sourced by ZipRecruiter
Industry
Biotechnology research and development
Company size
51 - 200 Employees
Headquarters location
Pittsburgh, PA, US
Year founded
2015