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Quality System Operation Specialist Jobs (NOW HIRING)

Quality System Specialist

Tustin, CA ยท On-site

$42.69 - $53.36/hr

๐Ÿš€ Senior Specialist, Quality Systems ๐Ÿ“ Tustin, CA | ๐Ÿ•’ Full-Time | ๐Ÿ—“ Monday-Friday ๐ŸŒฑ Help Ensure Quality in Life-Saving Biopharmaceuticals Are you passionate about Quality Systems ...

Quality System Specialist

Newark, CA ยท On-site

$78K - $88K/yr

With decades of industry experience and operations in key global markets, we combine engineering ... Quality System Specialist Job Function: Quality Department Report to: Senior Quality Assurance ...

Enter and maintain billing information in applicable systems. * Track billing deadlines and ... Operation Support Specialist. Contract & Billing Requirements * Develop working knowledge of ...

JOB SUMMARY The Operations Specialist - Collections provides advanced clerical, administrative, and ... Use Microsoft Office and other software systems to complete daily administrative and operational ...

Operation Specialist

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$53K - $75K/yr

Position Summary Binex-TNA is seeking a detail-oriented and motivated Operations Specialist to join ... Negotiate freight rates while maximizing profitability and maintaining service quality * Monitor ...

Senior Quality Operations Specialist

Albuquerque, NM ยท On-site

$80K - $110K/yr

Senior Quality Operations Specialist in Albuquerque, NM Build your future at Curia, where our work ... Identify opportunities to improve validation compliance, quality system effectiveness, and ...

Enter timecards, hours worked, and service data into internal systems. * Answer incoming calls and ... Support the operations team with general clerical tasks, reports, and administrative projects. What ...

Quality System Manager

Missoula, MT ยท On-site

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Head of Business Operations; Data, Software & IT teams; scientific and technical leaders; and ... This role owns the quality systems and cross-functional operating practices that make dependencies ...

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How much do quality system operation specialist jobs pay per hour?

As of Sep 11, 2026, the average hourly pay for quality system operation specialist in the United States is $34.38, according to ZipRecruiter salary data. Most workers in this role earn between $27.16 and $39.66 per hour, depending on experience, location, and employer.

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Quality System Specialist

Tustin, CA โ€ข On-site

$42.69 - $53.36/hr

Other

Medical, Dental, Vision, Retirement, PTO

Posted 22 days ago


Job description

๐Ÿš€ Senior Specialist, Quality Systems

๐Ÿ“ Tustin, CA | ๐Ÿ•’ Full-Time |

๐Ÿ—“ Mondayโ€“Friday


๐ŸŒฑ Help Ensure Quality in Life-Saving Biopharmaceuticals

Are you passionate about Quality Systems, CAPAs, deviations, GMP compliance, and documentation excellence? Weโ€™re looking for a Senior Specialist, Quality Systems to join a growing biopharmaceutical team supporting innovative biologic therapies.

If you thrive in a fast-paced quality environment and enjoy working with deviation investigations, CAPAs, quality documentation, and inspection readiness, this could be your next opportunity.


๐Ÿ”ฌ What You'll Do

โœ” Review, edit, and approve deviation reports, calibration exceptions, OOS, and OOL investigations

โœ” Support CAPA authoring, review, and approval activities

โœ” Prepare and review SOPs, forms, batch production records, and controlled documents

โœ” Participate in the generation and revision of quality systems and project documentation

โœ” Support development, validation, and stability documentation activities

โœ” Collaborate with cross-functional teams to resolve quality system issues and discrepancies

โœ” Represent Quality on multidisciplinary project teams

โœ” Provide support to internal and external customers on Quality topics

โœ” Maintain inspection readiness and support audit preparation activities

โœ” Support continuous improvement initiatives and Quality Management System activities


โœ… What We're Looking For


๐ŸŽ“ B.A. or B.S. degree (preferably in a Life Sciences field)


๐Ÿงช Minimum 4โ€“5 years of experience in the biopharmaceutical industry (preferably with biologics)


๐Ÿงซ Hands-on experience or exposure with:

โ€ข Quality Systems

โ€ข CAPA Management

โ€ข Deviations

โ€ข OOS Investigations

โ€ข OOL Investigations

โ€ข GMP Compliance

โ€ข Quality Documentation

โ€ข SOP Development

โ€ข Batch Production Records (BPRs)

โ€ข Root Cause Analysis

โ€ข Impact Assessments

โ€ข Inspection Readiness

โ€ข Controlled Documents

โ€ข Quality Management Systems (QMS)

โ€ข Technical Writing

โ€ข Document Management Systems


Bonus

โ€ข Experience with biologics preferred

โ€ข Experience using Quality Management Systems and electronic document management systems

โ€ข Strong technical writing and editing skills

๐Ÿ’ฐ Compensation Range

$42.69 โ€“ $53.36 per hour (depending on experience and qualifications)


Comprehensive Benefits

Health, Dental, and Vision Insurance

401(k) Matching

Paid Time Off

Career Growth Opportunities

๐Ÿ“ Please Note

โœ… On-site in Tustin, CA

๐Ÿ•’ Full-time Mondayโ€“Friday, 8:00 AMโ€“5:00 PM schedule

โœ… Overtime and weekend availability may be required

๐Ÿšซ No relocation assistance

๐Ÿšซ No visa sponsorship available

๐Ÿ‡บ๐Ÿ‡ธ Applicants must already be authorized to work in the U.S.

If this sounds like youโ€”or someone in your networkโ€”Iโ€™d love to connect!

#BiotechJobs #QualitySystems #SeniorSpecialist #QualityAssurance #CAPA #Deviations #OOS #GMP #Biologics #QualityManagement #TechnicalWriting #LifeSciences #Biopharma #Hiring #TustinCA