OPT Quality Auditor Jobs
Quality Auditor jobs on OPT require strong attention to regulatory standards, inspection procedures, and documentation practices. Most roles in manufacturing, pharmaceuticals, and food production qualify as specialty occupations, supporting H-1B visa sponsorship after OPT. Your 12-month standard OPT window, or 24-month STEM extension for engineering and science graduates, gives you meaningful time to prove value.
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Get Access To All JobsINTRODUCTION
For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we’ll help you build a career that you can feel passionate about.
Job Overview
Charles River Labs based in Charleston, SC is seeking an Associate Quality Assurance Auditor within our Quality team. Shift is M-F 11:30 AM - 8:00 PM.
The Associate QA Auditor will perform audits of quality control testing data for routine assays, incoming and in-process materials, process documentation and labeling to assure accuracy and compliance with Good Manufacturing Practice Regulations (GMP) and Standard Operating Procedures (SOP). Additional responsibilities include: Review of Accessory Batch Records, participating in team activities such as pre-audit walkthroughs, data reporting, and additional tasks as needed.
Essential Duties and Responsibilities
Under the training, mentorship and review of senior Quality Assurance personnel, learn and apply the principles of GMP compliance to work assignments including:
- Participate in review of SOPs and other controlled documents for compliance with all pertinent GMP regulations and internal policies.
- Perform raw data audits of documentation for temperature, humidity, and magnehelic gauges monitoring environmentally controlled areas, and autoclave/oven charts to ensure accuracy and compliance with applicable GMPs and Standard Operating Procedures.
- Review incoming raw material receipt packages for compliance with the requirements detailed in material specifications and applicable testing procedures.
- Review accessory product records for compliance with the requirements detailed in product specifications and applicable testing procedures.
- Review instrument release packages for compliance with the requirements detailed in product specifications and applicable testing procedures.
- Review equipment and process logbooks as required.
- Perform all other related duties as assigned.
QUALIFICATIONS
The following are the minimum requirements related to the Associate Quality Assurance Auditor position.
- Associate’s degree (A.S./A.A.) or equivalent, preferably in a life science or related discipline. Bachelor’s degree (B.S/B.A) preferred.
- 1-2 years of experience in a Quality Assurance role.
COMPENSATION
The pay range for this position is $22-$23/hr. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, and location.
About Microbial Solutions
Our Microbial Solutions business group has a comprehensive portfolio of endotoxin testing, microbial detection and microbial identification products and services is unlike any other, and has been purposefully designed to meet the complex and ever-changing needs of the industry. We help clients to ensure product safety and quality with easy-to-use yet robust testing solutions that satisfy regulatory requirements, support critical decision making and improve operational efficiencies.
About Charles River
Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients’ clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market.
With over 20,000 employees within 110 facilities in 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client’s unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world. And in 2019, revenue increased to $2.62 billion.
At Charles River, we are passionate about our role in improving the quality of people’s lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly supported the development of 80% of the drugs approved by the FDA in the last five years.
We’re committed to providing benefits that elevate your quality of life. Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility.
Equal Employment Opportunity
Charles River Laboratories is an Equal Opportunity Employer - all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin, veteran or disability status.
It is unlawful in some states (including 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.
If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to crrecruitment_US@crl.com. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.
INTRODUCTION
For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we’ll help you build a career that you can feel passionate about.
Job Overview
Charles River Labs based in Charleston, SC is seeking an Associate Quality Assurance Auditor within our Quality team. Shift is M-F 11:30 AM - 8:00 PM.
The Associate QA Auditor will perform audits of quality control testing data for routine assays, incoming and in-process materials, process documentation and labeling to assure accuracy and compliance with Good Manufacturing Practice Regulations (GMP) and Standard Operating Procedures (SOP). Additional responsibilities include: Review of Accessory Batch Records, participating in team activities such as pre-audit walkthroughs, data reporting, and additional tasks as needed.
Essential Duties and Responsibilities
Under the training, mentorship and review of senior Quality Assurance personnel, learn and apply the principles of GMP compliance to work assignments including:
- Participate in review of SOPs and other controlled documents for compliance with all pertinent GMP regulations and internal policies.
- Perform raw data audits of documentation for temperature, humidity, and magnehelic gauges monitoring environmentally controlled areas, and autoclave/oven charts to ensure accuracy and compliance with applicable GMPs and Standard Operating Procedures.
- Review incoming raw material receipt packages for compliance with the requirements detailed in material specifications and applicable testing procedures.
- Review accessory product records for compliance with the requirements detailed in product specifications and applicable testing procedures.
- Review instrument release packages for compliance with the requirements detailed in product specifications and applicable testing procedures.
- Review equipment and process logbooks as required.
- Perform all other related duties as assigned.
QUALIFICATIONS
The following are the minimum requirements related to the Associate Quality Assurance Auditor position.
- Associate’s degree (A.S./A.A.) or equivalent, preferably in a life science or related discipline. Bachelor’s degree (B.S/B.A) preferred.
- 1-2 years of experience in a Quality Assurance role.
COMPENSATION
The pay range for this position is $22-$23/hr. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, and location.
About Microbial Solutions
Our Microbial Solutions business group has a comprehensive portfolio of endotoxin testing, microbial detection and microbial identification products and services is unlike any other, and has been purposefully designed to meet the complex and ever-changing needs of the industry. We help clients to ensure product safety and quality with easy-to-use yet robust testing solutions that satisfy regulatory requirements, support critical decision making and improve operational efficiencies.
About Charles River
Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients’ clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market.
With over 20,000 employees within 110 facilities in 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client’s unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world. And in 2019, revenue increased to $2.62 billion.
At Charles River, we are passionate about our role in improving the quality of people’s lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly supported the development of 80% of the drugs approved by the FDA in the last five years.
We’re committed to providing benefits that elevate your quality of life. Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility.
Equal Employment Opportunity
Charles River Laboratories is an Equal Opportunity Employer - all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin, veteran or disability status.
It is unlawful in some states (including 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.
If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to crrecruitment_US@crl.com. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.
See all OPT Quality Auditor Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new OPT Quality Auditor Jobs.
Get Access To All JobsTips for Finding OPT Sponsorship as a Quality Auditor
Target STEM-designated programs
A STEM OPT extension gives you 36 months total. Quality Auditor roles tied to engineering, biology, or chemistry degrees often qualify. Confirm your CIP code with your DSO before accepting an offer to avoid surprises later.
Focus on regulated industries
Pharmaceuticals, medical devices, aerospace, and food manufacturing regularly sponsor H-1B visas for Quality Auditors. These industries operate under strict FDA, ISO, or FAA oversight, making your role essential and your sponsorship case straightforward to justify.
Highlight your audit certifications early
Credentials like CQA, CQE, or ISO 9001 Lead Auditor distinguish you from other candidates. Listing certifications prominently signals professional commitment and makes sponsorship conversations easier because employers see a long-term investment worth making.
Ask about sponsorship during the offer stage
Raise sponsorship directly when an employer extends an offer, not after you start. Ask specifically whether they have sponsored H-1B visas before. Past sponsorship history is the strongest indicator they will do it again.
Document your specialty occupation argument
Quality Auditor roles require a degree in a specific technical field, which satisfies the H-1B specialty occupation standard. Keep records of how your academic background directly applies to your job duties. This documentation supports the I-129 petition later.
Use your OPT period to build compliance expertise
Employers sponsor workers they cannot easily replace. Use your OPT months to own a specific compliance area, such as supplier audits, CAPA management, or validation protocols. Demonstrated expertise in a niche makes the sponsorship conversation much easier.
Quality Auditor OPT: Frequently Asked Questions
Do Quality Auditor jobs typically qualify for the STEM OPT extension?
It depends on your degree, not just your job title. If your degree is in engineering, biology, chemistry, or a related STEM field and your Quality Auditor role applies that technical background directly, you likely qualify. Confirm your CIP code with your DSO. Roles in pharmaceutical or manufacturing quality assurance are the most common qualifying combinations.
How do I find Quality Auditor employers who sponsor OPT and H-1B visas?
Migrate Mate filters job listings specifically for employers open to OPT work authorization and visa sponsorship, so you are not wasting time applying to companies that will reject you at the authorization screen. Regulated industries like medical devices and pharmaceuticals are your best targets, as these companies have established immigration programs and frequently sponsor Quality Auditors.
What does the specialty occupation requirement mean for Quality Auditor H-1B sponsorship?
For H-1B purposes, a specialty occupation requires a bachelor's degree or higher in a specific field directly related to the job. Quality Auditor roles in regulated industries generally meet this standard because they require applied knowledge of engineering, science, or a technical discipline. Roles where any general degree satisfies the requirement are harder to justify. Industry and job duties matter significantly.
Can I start a Quality Auditor job before my EAD card arrives?
No. You cannot legally begin working until you have your physical EAD card in hand. Do not let an employer pressure you to start early. Your OPT start date on the EAD is the earliest you can work, and your I-20 must reflect the correct program end date. Confirm both documents are accurate before your first day.
What happens to my OPT if my Quality Auditor employer goes through layoffs?
You have a 90-day unemployment allowance across your entire OPT period, or 150 days if you are on a STEM extension. Days without employment accumulate, not reset. If you are laid off, begin your job search immediately. Exceeding the allowance violates your status. Report any employment changes to your DSO within 10 days, as required.