Top 74 Quality assurance specialist Jobs in Fountain Valley, Ca

Quality Specialist
Hims & Hers —Los Alamitos, CA
- $70,000 - $85,000 a year
- Full-time
- Remote
- Microsoft Outlook
- Word processing
- Mid-level
- Employee stock purchase plan
- Health insurance
Quality Assurance Specialist - Documentation Control
nRichDX —Irvine, CA
- $65,000 - $80,000 a year
- Full-time
- Laboratory experience
- Mid-level
- Bachelor's degree
- Health insurance
- Dental insurance
Quick Apply
7d
Quality Systems Specialist
RxSight, Inc. —Aliso Viejo, CA
- $85,000 - $100,000 a year
- Full-time
- Computer literacy
- Mid-level
- Bachelor's degree
Quick Apply
4d
QUALITY IMPROVEMENT/QUALITY ASSURANCE (QI/QA) SPECIALIST
Nhan Hoa Comprehensive Health Care Clinic —Garden Grove, CA
- $31 - $36 an hour
- Full-time
- 3 years
- Bachelor's degree
- Travel
- AD&D insurance
- Health insurance
Quick Apply
QA Specification Specialist
GuruNanda LLC —Buena Park, CA
- $70,000 - $90,000 a year
- Full-time
- Mid-level
- 3 years
- Bachelor's degree
- Health insurance
- Dental insurance
Quick Apply
Quality Improvement Specialist
Los Angeles Centers for Alcohol and Drug Abuse —Santa Fe Springs, CA
- $23.06 - $26.41 an hour
- Full-time
- Current TB test
- Pass drug screening
- Data analysis skills
- Health insurance
- Dental insurance
Quick Apply
13h
Specialist (Lot Disposition), Quality Assurance
Avid Bioservices —Tustin, CA
- $32.69 - $40.86 an hour
- Overtime
- Mid-level
- Bachelor's degree
- In-person
- Health insurance
- Dental insurance
Quick Apply
4d
Quality Specialist
Ducommun Inc. —Huntington Beach, CA
- $71,000 - $85,000 a year
- Management
- Mid-level
- High school diploma or GED
Quick Apply
Specialist, Quality Control
Avid Bioservices —Tustin, CA
- $32.30 - $40.38 an hour
- Overtime
- Mid-level
- Ability to lift 25 pounds
- Commercial
- Health insurance
- Dental insurance
Quick Apply
4d
Quality Analyst Specialist
DZYNE Technologies LLC. —Irvine, CA
- $85,000 - $96,000 a year
- Full-time
- Computer science
- Computer Science
- Mid-level
- Paid holidays
- Health insurance
Digital Product Specialist
Tri Pointe Homes Holdings, Inc. —Irvine, CA
- $106,900 - $120,600 a year
- Full-time
- Marketing
- Research
- Mid-level
- Paid jury duty
- Health savings account
8d
Quality Specialist
Henkel —Rancho Dominguez, CA
- $47,840 - $54,080 a year
- Full-time
- Hybrid work
- Mid-level
- Older adults
- Paid holidays
- Health insurance
Quick Apply
Associate Specialist, Quality Assurance
Avid Bioservices —Tustin, CA
- $25.38 - $31.73 an hour
- Overtime
- Bachelor of Science
- In-person
- Training & development
- Health insurance
- Dental insurance
Quick Apply
11d
Regulatory Affairs and Quality Assurance Specialist
SprintRay —Huntington Beach, CA
- $90,000 - $120,000 a year
- Full-time
- 5 years
- Research
- Mid-level
Environmental Quality Assurance Specialist
TITAN Environmental Solutions, Inc. —Fullerton, CA
- $65,000 - $85,000 a year
- Full-time
- Microsoft Word
- Laboratory experience
- Office
- Paid holidays
- Dental insurance
Quick Apply
Quality Assurance Specialist
Pediatric Associates —San Pedro, CA
- Full-time
- HIPAA
- Mid-level
- 3 years
Quality Assurance Specialist
Diagnostic Laboratory Science —Garden Grove, CA
- $20 - $22 an hour
- Part-time
- Bachelor's degree
- In-person
- Communication skills
- Health insurance
- Dental insurance
Quick Apply
Quality Specialist, EW
Anduril Industries —Irvine, CA
- $41 - $54 an hour
- Email
- CAD
- Mid-level
- Experience equivalent to degree accepted
Quick Apply
Customer Quality Systems Specialist
Hawkins Inc —Fullerton, CA
- $28 - $33 an hour
- Microsoft Excel
- Microsoft Outlook
- 5 years
- Employee stock purchase plan
- Paid holidays
Quick Apply
3d
SENIOR QA SPECIALIST - VALIDATION
LGM Pharma, LLC —Irvine, CA
- $75,000 - $90,000 a year
- Full-time
- Management
- Engineering
- Continuous improvement
Quick Apply
11d

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Quality Specialist

Hims & Hers -
Los Alamitos, CA

Apply Now

Job Details

Full-time
$70,000 - $85,000 a year

Benefits

Employee stock purchase plan
Health insurance
Unlimited paid time off
Dental insurance
Parental leave
Vision insurance
401(k) matching

Qualifications

Incident investigation techniques for hazard identification
Regulatory inspections
USP 797
Statistics
Content creation for technical audiences
Microsoft Outlook
Defect resolution root cause analysis
Presentation software
Document control experience within pharmaceutical industry
ISO standards
Quality control statistical data analysis
Word processing
Preventive action implementation
Contamination control
Technical writing experience within manufacturing
Production deviation management
Compliance audits & assessments
Visio
Corrective and preventive actions (CAPA)
FDA 21 CFR Part 11
Cleanroom protocols
Trend analysis
Quality control audit
Statistical analysis
Quality risk management
Quality assurance experience within pharmaceutical industry
Compliance documentation
Regulatory/legal compliance standards in production
Biomedical regulatory compliance
Quality control experience within pharmaceutical industry

Full Job Description

Hims & Hers is the leading health and wellness platform, on a mission to help the world feel great through the power of better health. We are redefining healthcare by putting the customer first and delivering access to care that is affordable, accessible, and personal, from diagnosis to treatment to delivery. No two people are the same, so we provide access to personalized care designed for results. By normalizing health & wellness challenges and innovating on their solutions, we’re making better health outcomes easier to achieve.

Hims & Hers is a public company, traded on the NYSE under the ticker symbol “HIMS.” To learn more about the brand and offerings, you can visit hims.com/about and hims.com/how-it-works . For information on the company’s outstanding benefits, culture, and its talent-first flexible/remote work approach, see below and visit www.hims.com/careers-professionals.

About the Role:

The Quality Specialist is an individual contributor within the site Quality Unit, supporting Quality activities in a sterile injectable cGMP / 503B environment. The role executes day-to-day quality oversight “on the floor” and within the Quality Management System (QMS) — including in-process and finished-product oversight, batch record review, environmental monitoring support, deviations and CAPA, change control, document control, and investigations — to ensure products meet identity, strength, quality, purity, and sterility-assurance requirements in alignment with 21 CFR Parts 210, 211, and 11, Section 503B of the FD&C Act, and USP standards.

Working under the direction of QA management, the Quality Specialist supports release and disposition activities, identifies and escalates significant quality events, and helps sustain a state of continuous inspection readiness and a culture of compliance and continuous improvement.

Key Responsibilities:

Provide in-process and finished-product quality oversight on the manufacturing floor, including monitoring of manufacturing and aseptic processing operations for compliance with approved procedures, cGMP, and USP standards.
Perform batch record review and support batch disposition, verifying that documentation, testing, and investigations are satisfactorily completed prior to release in accordance with approved procedures.
Review and provide input on procedures, specifications, master/executed batch records, and controlled forms to ensure accuracy, completeness, and regulatory compliance.
Support the environmental monitoring (EM) program, including review of data and prompt escalation of excursions and adverse trends.
Support packaging and labeling controls, including label issuance, reconciliation, and verification to prevent mix-ups and labeling errors.
Assist with incoming material inspection and material control — sampling, Certificate of Analysis (COA) review and acceptance, and disposition of components and raw materials.
Support vendor/supplier quality oversight and the management of contract-laboratory testing, including sample submission, tracking, and review of results.
Support document control and the SOP lifecycle — authoring, revision, routing, and periodic review of GMP documentation — and maintain a current, compliant, audit-ready repository.
Initiate, support, and document deviations, OOS, and CAPAs, including investigation, root cause analysis, and verification of effectiveness.
Support quality system programs including, change control, document control, training, complaints, quality event management, etc. and the implementation of Trackwise eQMS.
May serve as a process owner for an element of the quality system, based on experience and background.
Support risk management and assessment activities for assigned areas.
Participate in internal and external (third-party and regulatory) audits and help maintain continuous inspection readiness.
Support preparation of the Annual Product Quality Review (APQR) through data compilation and trending.

You Have:

2+ years of experience in Quality Assurance and/or Quality Control within an FDA-regulated environment; sterile injectable cGMP or 503B outsourcing facility experience strongly preferred.
Working knowledge of FDA cGMP (21 CFR Parts 210, 211, and 11) and Section 503B of the FD&C Act.
Working knowledge of USP-NF standards — including <795>, <797>, and <800> — and applicable monographs.
Aseptic processing experience and familiarity with ISO 14644, contamination control, and sterility-assurance principles.
Hands-on experience with batch record review, in-process and finished-product inspection, and product disposition against defined specifications.
Experience with core quality system elements — deviations/CAPA, change control, document control, and investigations — within paper and/or electronic QMS (e.g., TrackWise).
Experience supporting internal and regulatory (e.g., FDA) audits and inspections.
Strong foundation in root cause analysis, risk assessment, and statistical/trend analysis.
Excellent technical writing, documentation, and verbal/written communication skills.
Strong computer skills (Word, Excel, Visio, PowerPoint, Outlook); familiarity with eQMS (e.g. Trackwise) a plus.
Ability to prioritize and work independently in a fast-paced environment; a highly motivated, detail-oriented self-starter.

Our Benefits (there are more but here are some highlights):

Competitive salary & equity compensation for full-time roles
Unlimited PTO, company holidays, and quarterly mental health days
Comprehensive health benefits including medical, dental & vision, and parental leave
Employee Stock Purchase Program (ESPP)
401k benefits with employer matching contribution
Offsite team retreats

We are committed to building a workforce that reflects diverse perspectives and prioritizes ethics, wellness, and a strong sense of belonging. If you're excited about this role, we encourage you to apply—even if you're not sure if your background or experience is a perfect match.

Hims considers all qualified applicants for employment, including applicants with arrest or conviction records, in accordance with the San Francisco Fair Chance Ordinance, the Los Angeles County Fair Chance Ordinance, the California Fair Chance Act, and any similar state or local fair chance laws.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Hims & Hers is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans in our job application procedures. If you need assistance or an accommodation due to a disability, please contact us at [email protected] and describe the needed accommodation. Your privacy is important to us, and any information you share will only be used for the legitimate purpose of considering your request for accommodation. Hims & Hers gives consideration to all qualified applicants without regard to any protected status, including disability. Please do not send resumes to this email address.

To learn more about how we collect, use, retain, and disclose Personal Information, please visit our Global Candidate Privacy Statement.

Compensation Range: $70K - $85K

Apply Now

Refine Your Search

quality assurance specialist jobs in fountain valley, ca

Quality Specialist

Quality Assurance Specialist - Documentation Control

Quality Systems Specialist

QUALITY IMPROVEMENT/QUALITY ASSURANCE (QI/QA) SPECIALIST

QA Specification Specialist

Quality Improvement Specialist

Specialist (Lot Disposition), Quality Assurance

Quality Specialist

Specialist, Quality Control

Quality Analyst Specialist

Digital Product Specialist

Quality Specialist

Associate Specialist, Quality Assurance

Regulatory Affairs and Quality Assurance Specialist

Environmental Quality Assurance Specialist

Quality Assurance Specialist

Quality Assurance Specialist

Quality Specialist, EW

Customer Quality Systems Specialist

SENIOR QA SPECIALIST - VALIDATION

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