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Biotechnology Quality Assurance Jobs (NOW HIRING)

CorDx

Quality Assurance Manager

Alpharetta, GA ยท 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

Alpharetta, GA ยท On-site

Who is CorDx๏ผŸ 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 ...

Legend Biotech US

Director, QA Operations

Raritan, NJ ยท On-site

Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life ... Legend Biotech is seeking a Director, QA Operations as part of the Quality team based in Raritan ...

Legend Biotech USA, Inc.

Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life ... Legend Biotech is seeking a Director, QA Operations as part of the Quality team based in Raritan ...

Jj

Quality Assurance Specialist ||

Raritan, NJ ยท On-site

Quality Assurance Job Category: Professional All Job Posting Locations: Raritan, New Jersey, United ... Janssen Biotech, Inc. is part of the Janssen Pharmaceutical Companies. Janssen Biotech, Inc., one ...

Danaher

Quality Assurance (QA) Specialist

Boulder, CO ยท On-site

$63K - $80K/yr

... biotechnology? AtIntegrated DNA Technologies (IDT),one ofDanaher's15+ operating companies, our work ... The Quality Assurance (QA) Specialist is responsibleforproviding administration, coordination, and ...

New

Actalent

Quality Assurance Technician

Somerville, NJ

Quality Assurance Technician The Quality Assurance Technician ensures that sterilization processes ... Familiarity with ISO-based quality systems in pharmaceutical, biotech, medical device, or contract ...

PSG Global Solutions

Quality Assurance

Groton, CT

... biotechnology and medical companies. As specialists in recognising talent we pride ourselves on not ... Perform a range of duties within the Pharm Sci QA group, associated with oversight and support of ...

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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 12, 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 Assurance Manager

Alpharetta, GA โ€ข On-site

CorDx
Biotechnology Research and Developmentย โ€ขย 1 - 5K employees
Learn more about CorDxexternal

Full-time

Medical, Retirement, PTO

Re-posted 19 days ago

Job description

Who is CorDx?
CorDx a multi-national biotech organization focused on pushing the limits of innovation and supply in global health. With over 2,100 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious disease such as COVID-19, pregnancy, drugs of abuse, biomarkers, and more. CorDx is at the cutting edge of technology, artificial intelligence, and data science with the goal of delivering diagnostic solutions to some of the most critical questions in healthcare.
Position: QA Manager
Location: Alpharetta/Chamblee
Position Type: 5 days Onsite Exempt Position
Job Summary: We are seeking an experienced Quality Assurance Manager to lead our quality assurance team in the development, manufacturing, and distribution of Class II IVD devices. The ideal candidate will have at least 7 years of experience in the IVD industry, with a strong background in quality management systems, regulatory compliance, and team leadership.
Key Responsibilities:
Quality Systems & Compliance
  • Develop, implement, and maintain Quality Management Systems (QMS) in accordance with, US FDA, ISO 13485, and applicable regulations.
  • Lead internal and external audits, regulatory inspections, and corrective action plans (CAPAs).
  • Oversee batch record reviews, deviations, non-conformance reports (NCRs), and change controls to maintain product quality and integrity.

Process & Product Quality Assurance
  • Develop and enforce Standard Operating Procedures (SOPs) and best practices to ensure consistent quality across manufacturing operations.
  • Collaborate with R&D, production, and regulatory affairs teams to ensure new products and processes meet quality standards.
  • Monitor and analyze quality metrics (KPIs) to drive continuous improvement initiatives.
  • Ensure adherence to Good Documentation Practices (GDP) and data integrity policies.

Leadership & Team Development
  • Lead, mentor, and develop the QA team, fostering a culture of quality, compliance, and continuous improvement.
  • Train manufacturing and quality teams on quality systems, and root cause analysis (RCA) methodologies.
  • Serve as the primary point of contact for quality-related issues and escalations.

Risk Management & Continuous Improvement
  • Identify quality risks and implement proactive mitigation strategies.
  • Lead investigations and root cause analyses for product defects, deviations, and non-conformances.
  • Drive LEAN, Six Sigma, or other process improvement initiatives to enhance efficiency and reduce waste.
  • Stay updated on industry trends, new regulations, and technological advancements in medical device IVD quality assurance.

Requirements
  • Bachelor's or Master's degree in Biotechnology, Microbiology, Chemistry, Biochemistry, Pharmaceutical Sciences, or related field.
  • 7+ years of experience in quality assurance within biotech, pharmaceutical, or medical device manufacturing.
  • 3+ years in a managerial or leadership role overseeing QA teams.

  • Skills & Competencies
  • Strong knowledge of US FDA, ISO 13485, and other regulatory standards.
  • Experience with QA audits, inspections, CAPA investigations, and risk management.
  • Proficiency in QMS software and documentation control systems.
  • Strong analytical and problem-solving skills, with a data-driven approach to decision-making.
  • Excellent leadership, communication, and cross-functional collaboration skills.

Benefits
  • Medical Insurance Plan
  • Retirement Plan
  • Paid Time Off
  • Training & Development
    We are an equal-opportunity employer and celebrate diversity, recognizing that diversity of thought and background builds stronger teams. We approach diversity and inclusion seriously and thoughtfully. We do not discriminate on the basis of race, religion, color, ancestry, national origin, caste, sex, sexual orientation, gender, gender identity or expression, age, disability, medical condition, pregnancy, genetic makeup, marital status, or military service.

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