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Biotechnology Quality Assurance Jobs (NOW HIRING)

DivIHN

QA Contractor, GMP Quality Assurance

NC · On-site

... biotech Quality Management system, such as Trackwise, ZenQMS, Veeva, is a requirement * Strong understanding of GMP guidelines and Quality Systems with the ability to apply GMPs in conformance to U.S ...

Krystal Biotech

Quality Assurance Associate

Moon, VA · On-site

$60 - $80/hr

About Krystal Bio At Krystal Biotech, we bring together the brightest and most eager minds to ... Provide oversight of daily QA functions which include review and approval of records generated by ...

Krystal Biotech

$60 - $80/hr

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 ...

CorDx

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 ...

CorDx

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 ...

CorDx

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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Biotechnology Quality Assurance information

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How much do biotechnology quality assurance jobs pay per hour?

As of Sep 9, 2026, the average hourly pay for biotechnology quality assurance in the United States is $23.19, according to ZipRecruiter salary data. Most workers in this role earn between $17.55 and $24.28 per hour, depending on experience, location, and employer.

What is biotechnology quality assurance?

Biotechnology Quality Assurance (QA) refers to the processes and systems used to ensure that biotechnology products, such as pharmaceuticals and medical devices, meet required quality standards and regulatory guidelines. QA professionals develop, implement, and monitor standard operating procedures, conduct audits, and oversee documentation to maintain product safety and efficacy. They play a critical role in ensuring compliance with laws and regulations set by agencies like the FDA or EMA, helping to prevent errors and maintain public trust in biotech products.

What are some common challenges faced by professionals in biotechnology quality assurance, and how can they be addressed?

Professionals in Biotechnology Quality Assurance often face challenges such as keeping up with evolving regulatory requirements, ensuring data integrity, and managing cross-functional communication. Staying current with industry regulations through continuous training and regular review of updates from agencies like the FDA and EMA is essential. Additionally, fostering a culture of transparency and collaboration with R&D, manufacturing, and regulatory affairs teams helps address potential compliance issues early. Implementing robust documentation processes and regular audits also supports maintaining high-quality standards.

What are the key skills and qualifications needed to thrive as a biotechnology quality assurance professional, and why are they important?

To thrive as a Biotechnology Quality Assurance professional, a strong background in biology or chemistry, knowledge of regulatory standards (such as GMP, GLP, or ISO), and relevant experience in quality control or assurance are essential. Familiarity with laboratory information management systems (LIMS), auditing tools, and quality management software is typically required, along with certifications like ASQ Certified Quality Auditor (CQA) being advantageous. Attention to detail, analytical thinking, effective communication, and problem-solving skills help professionals excel in managing compliance and continuous improvement. These abilities ensure the integrity of products and processes, safeguard patient safety, and maintain regulatory compliance in the highly regulated biotech industry.

What is the difference between Biotechnology Quality Assurance vs Biotechnology Quality Control?

AspectBiotechnology Quality AssuranceBiotechnology Quality Control
Primary FocusEnsuring processes and systems meet quality standardsTesting and inspecting products for quality and compliance
ResponsibilitiesDeveloping protocols, audits, compliance documentationSampling, testing, analyzing products and raw materials
Work EnvironmentDocumentation, audits, process reviewsLaboratory testing, sample analysis
CertificationsGMP, ISO, regulatory compliance trainingLab techniques, testing certifications

Biotechnology Quality Assurance focuses on maintaining quality systems and compliance processes, while Biotechnology Quality Control involves testing products to ensure they meet quality standards. Both roles are essential in biotech manufacturing, often working closely but with distinct responsibilities.

What cities are hiring for Biotechnology Quality Assurance jobs?

Cities with the most Biotechnology Quality Assurance job openings:

What states have the most Biotechnology Quality Assurance jobs?

States with the most job openings for Biotechnology Quality Assurance jobs include:

What are popular job titles related to Biotechnology Quality Assurance jobs?

For Biotechnology Quality Assurance jobs, the most frequently searched job titles are:

Biotechnology Quality Assurance jobs near you

Quality Associate II - QMS (Boerne, TX)

Boerne, TX • On-site

EKF Diagnostics
See more jobs at EKF Diagnosticsexternal

$60 - $80/hr

Other

Posted 7 days ago

Job description

Vacancies at EKF in point-of-care diagnostics and life sciences biotechnology

Quality Associate II – QMS

EKF is seeking a Quality Associate II, based in Boerne, TX, to support quality assurance activities and ensure compliance within a regulated manufacturing environment.

Responsibilities include reviewing batch records, supporting product release, managing deviations and CAPAs, assisting with audits, and maintaining quality documentation in line with GMP and regulatory standards. Candidates should have experience in quality assurance within manufacturing, strong attention to detail, and knowledge of quality systems and compliance requirements.

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