Quality Specialist – GMP / CAPA / Quality Remediation

OVERVIEW:

About the job:

***Candidates must be authorized to work in the U.S. without sponsorship***

***Third-party/C2C arrangements are not available for this opportunity***

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Our client, a US Fortune 250 company and a global medical technology corporation serving customers in Clinical Labs, Health care research & Pharmaceutical industry, seeks an accomplished Quality Specialist – GMP / CAPA / Quality Remediation.

** JOB #: 3204

** JOB TITLE: Quality Specialist – GMP / CAPA / Quality Remediation

** JOB LOCATION: Onsite role at 9450 South State Street Sandy UT 84070

** JOB DURATION: Duration: 6-month contract (possible extension)

** WORK SCHEDULE: Monday – Friday | 8:00 AM – 5:00 PM

Pay Rate: $45.00/hr. – $47.00/hr

POSITION SUMMARY

• This opportunity is ideal for professionals with strong experience in CAPA management, GMP compliance, deviation investigations, technical writing, and risk assessment within pharmaceutical or medical device environments.

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KEY RESPONSIBILITIES:

• Develop, manage, and execute CAPA records aligned with internal quality standards and regulatory requirements
• Review and author investigations, protocols, reports, technical documents, and quality records
• Apply working knowledge of 21 CFR Part 211, GMP regulations, and quality remediation processes
• Identify compliance gaps, quality risks, and remediation opportunities
• Partner with SMEs and cross-functional teams to support CAPA closure, audit readiness, and project timelines
• Support or author risk assessments and risk management documentation
• Utilize science- and risk-based methodologies aligned with ICH Q9 principles

JOB REQUIREMENTS

• Education: Bachelor’s Degree required
• Experience supporting quality remediation initiatives in regulated environments
• Strong CAPA and GMP compliance experience
• Experience with risk assessments and risk management processes
• Familiarity with ICH Q9 methodologies
• Experience reviewing or authoring deviation investigations, root cause analyses, corrective action plans, and related quality documentation

Preferred Industry Background:

• Pharmaceutical Manufacturing
• Medical Device
• Biotech
• FDA-Regulated Manufacturing Environments

GMP Quality Specialist, CAPA Specialist, Quality Remediation, 21 CFR Part 211, Technical Writing, Deviation Investigations, Root Cause Analysis, Risk Assessment, Risk Management, ICH Q9, Audit Readiness, Pharmaceutical Quality, Medical Device Quality, GMP Compliance, Corrective Action Preventive Action

If you meet the qualifications and are interested in learning more about this opportunity, apply today.

Recruiter Contact Info

Lalit Malgotra

Email: lalit.malgotra@ameritconsulting.com

www.ameritconsulting.com

I'd love to talk to you if you think this position is right up your alley, and assure prompt communication, whichever direction. If you're looking for rewarding employment and a company that puts its employees first, we'd like to work with you.

Company Overview:

Amerit Consulting is a nationwide staffing and consulting firm supporting Fortune 500 clients across healthcare, technology, engineering, and professional services. With over 2,000 employees across 47 states, Amerit specializes in contract, temporary, and direct hire staffing solutions.

Amerit Consulting provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training. Applicants, with criminal histories, are considered in a manner that is consistent with local, state and federal laws.