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Clean Room Quality Assurance Jobs (NOW HIRING)

Conduct visual inspections of products and components in the clean room to ensure quality and compliance with specifications. * Handle clinical packaging and labeling tasks with strong attention to ...

Technician - Clean Room

Seattle, WA · On-site

$24.74 - $34.63/hr

... quality teams. * Collaborate with team members and cross-functional groups to ensure production ... As a Clean Room Technician, you will be part of a highly skilled team specializing in the precision ...

Technician - Clean Room

Seattle, WA · On-site

$24.74 - $34.63/hr

As a Clean Room Technician at Blue Origin, you will provide tactical and technical support to ... quality teams. * Collaborate with team members and cross-functional groups to ensure production ...

Follow strict clean room protocols and quality standards * Inspect finished products to ensure they meet medical device requirements Qualifications * Experience in clean room or medical device ...

Clean Room Packager This role involves working in a clean room environment to assemble, package ... Ability to maintain production speed while ensuring quality. * At least 6 months of manufacturing ...

Senior QA Specialist l, Drug Substance (DS) Work location: Cranbury, NJ WuXi Biologics is a leading ... Work is generally performed in a clean-room environment generally seated but may require standing ...

... clean room standards to produce safe, highly nutritious, pesticide-free, non-GMO vegetables with ... The Quality Assurance Technician reports to the Quality Assurance Lead. Summary: The Quality ...

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Clean Room Quality Assurance information

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How much do clean room quality assurance jobs pay per hour?

As of Jun 15, 2026, the average hourly pay for clean room quality assurance in the United States is $22.83, according to ZipRecruiter salary data. Most workers in this role earn between $17.55 and $25.72 per hour, depending on experience, location, and employer.

What are some common challenges faced in a Clean Room Quality Assurance role and how can they be managed?

One of the main challenges in a Clean Room Quality Assurance role is maintaining strict compliance with contamination control protocols while ensuring production efficiency. Professionals in this role must be vigilant about gowning procedures, particulate monitoring, and documentation accuracy, as even minor lapses can affect product quality. Collaboration with production and maintenance teams is essential to promptly address deviations or equipment issues. Developing a proactive mindset, strong communication skills, and attention to detail are key to effectively managing these challenges and supporting a culture of continuous improvement.

What is the difference between Clean Room Quality Assurance vs Clean Room Manufacturing Technician?

AspectClean Room Quality AssuranceClean Room Manufacturing Technician
Required CredentialsQuality assurance certifications, GMP, ISO standardsTechnical training, manufacturing certifications
Work EnvironmentClean room, quality control labsClean room, production floor
Employer & IndustryPharmaceutical, biotech, semiconductorPharmaceutical, biotech, semiconductor
Common Search IntentQuality standards, compliance, auditsProduction processes, equipment operation

Clean Room Quality Assurance professionals focus on maintaining quality standards, conducting audits, and ensuring compliance with industry regulations. In contrast, Clean Room Manufacturing Technicians handle the hands-on production, operating equipment, and following manufacturing protocols. Both roles are essential in regulated industries like pharmaceuticals and semiconductors, but they differ in responsibilities and focus areas.

What are Clean Room Quality Assurance professionals?

Clean Room Quality Assurance professionals are responsible for ensuring that clean room environments meet strict regulatory and quality standards, particularly in industries like pharmaceuticals, biotechnology, and electronics. Their duties include monitoring environmental conditions, inspecting processes, verifying compliance with protocols, and documenting results to prevent contamination. They play a crucial role in maintaining product integrity and safety by enforcing cleanliness, proper gowning, and operational procedures within controlled environments. These professionals often collaborate with production teams, auditors, and regulatory agencies to maintain certifications and pass inspections.

What are the key skills and qualifications needed to thrive as a Clean Room Quality Assurance specialist, and why are they important?

To thrive as a Clean Room Quality Assurance specialist, you need a strong understanding of quality control processes, contamination control, and industry-specific regulations, often supported by a degree in science or engineering. Familiarity with tools like particle counters, environmental monitoring systems, and experience with ISO 14644 standards or GMP certification are typically required. Attention to detail, strong organizational skills, and effective communication set top performers apart in this role. These skills and qualifications are crucial to ensure product safety, regulatory compliance, and consistent quality in highly controlled environments.
What states have the most Clean Room Quality Assurance jobs? States with the most job openings for Clean Room Quality Assurance jobs include:
Infographic showing various Clean Room Quality Assurance job openings in the United States as of June 2026, with employment types broken down into 75% Full Time, and 25% Part Time. Highlights an 94% Physical, 1% Hybrid, and 5% Remote job distribution, with an average salary of $47,496 per year, or $22.8 per hour.

Quality & Regulatory (QA/RA) Manager

Fortifi Food Processing Solutions

Wakeman, OH • On-site

Full-time

Posted 12 days ago


Job description

POSITION SUMMARY:
The QA/RA Manager provides leadership, direction and hands-on involvement with Regulatory Affairs and Quality Management Systems. You will be able to influence the businesses performance by maintaining compliance with domestic quality system as required for Medical Device Manufacturers involved with Clean Room Operations, and through support of other functional departments or product staff in supplying quality and regulatory input and feedback. Using prior education and work experience knowledge, helps assure compliance with overall regularity requirements, site, and UDI requirements.
RESPONSIBILITIES:
The duties & responsibilities of the QA/RA Manager include Regulatory Activities, Corporate Quality, oversight of Plant Quality, Microbiology/Sterilization and Document Control, but are not necessarily limited to the following responsibilities:
  • Developing and maintaining quality and regulatory systems and system elements in conformity with domestic medical device agency regulations and requirements.
  • Achieves quality assurance operational objectives by contributing information and analysis to strategic plans and reviews; preparing and completing action plans; implementing regulatory and quality activities, initiating, and executing audits (internal and external); determining system improvements; implementing change.
  • Meets quality assurance financial objectives by estimating requirements; preparing an annual budget; scheduling expenditures; analyzing variances; initiating corrective actions.
  • Working knowledge of device and biologic frameworks Design Control and/or Quality by Design. Must be able to guide team through phases, understand documentation and testing requirements, and maintain files.
  • Participating in the development and execution of installation, operational and performance qualifications of equipment, (IQ, OQ and PQ) including the clean room itself.
  • Act as UDI information coordinator, including:
    • Managing data within the UDI spreadsheet, including updates due to product changes
    • Completing UDI system data entry throughout the product lifecycle (e.g., GUDID Label Data Entry User, EUDAMED)
    • Responding to regulatory agency questions with support from the Quality/Regulatory Director
    • Manage UDI system access (e.g., GUDID, EUDAMED)
  • Prepares quality documentation (ERTs, CRTs and Management Review) and reports by collecting, analyzing, and summarizing information and trends including failed processes, stability studies, recalls, corrective actions, and re-validations.
  • Updates job knowledge by studying trends in and developments in quality management; participating in educational opportunities; reading professional publications; maintaining personal networks; participating in professional organizations (Med Con, ASQ, AAMI).
  • Manages supplier controls through the Approved Supplier List (ASL) and conducts supplier audits.

Skills/Qualifications:
EDUCATION AND EXPERIENCE
  • BS or BA degree in a life science, or similar with advanced experience in QA/RA areas or related training required
  • 5 - 7 years' experience in QA and Regulatory Affairs Knowledge and direct working experience with ISO and FDA GMPs Regulations.
  • Advanced training and certifications related to quality assurance a plus.

SKILLS, SPECIALIZED KNOWLEDGE AND ABILITIES
  • Demonstrated success in leading and developing a collaborative team is essential.
  • Ability to work with Government officials and FDA/ISO auditors.
  • Effective project management skills, excellent interpersonal, verbal, and written communications skills.
  • The ability to exercise authority, manage conflict, and influence others to a point of view in a positive way.
  • Customer, team-focused, proactive, and seeks continuous improvement.
  • Ability to remain calm and composed in stressful situations.
  • Ability to work with and communicate well with other groups outside of QA/RA.
  • Ability to lead meetings and small groups.
  • Working knowledge of Microsoft Word, Excel, and Master Control or a Cloud based quality systems.
  • Working knowledge of ERP & PLM systems

PERSONAL CHARACTERISTICS:
Behave Ethically: Understand ethical behavior and business practices and ensure that own behavior and the behavior of others is consistent with these standards and aligns with the values of the organization.
Communicate Effectively: Speak, listen and write in a clear, thorough and timely manner using appropriate and effective communication tools and techniques.
Creativity/Innovation: Develop new and unique ways to improve function efficiency and performance.
Foster Teamwork: Work cooperatively and effectively with others to set goals, resolve problems, and make decisions that enhance process effectiveness.
Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws.
For further information, please review the Know Your Rights notice from the Department of Labor.