OPT Quality Assurance Auditor Jobs
Quality Assurance Auditor roles are a strong fit for F-1 OPT students with degrees in engineering, computer science, or a related technical field. Most positions qualify as specialty occupations, making them straightforward for OPT authorization. STEM OPT extension eligibility is common, giving you up to three years of total work authorization.
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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.
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Get Access To All JobsTips for Finding OPT Sponsorship as a Quality Assurance Auditor
Confirm your degree aligns with the role
QA Auditor positions require a field-specific degree to qualify as a specialty occupation. Engineering, computer science, information systems, or quality management degrees map most cleanly. A mismatch between your major and the job description can complicate OPT authorization.
Target employers with established QA teams
Companies with dedicated quality assurance departments are far more familiar with OPT work authorization than startups hiring their first QA hire. Manufacturing, medical device, aerospace, and software firms typically have HR processes already in place for international candidates.
Verify the role qualifies for STEM OPT extension
QA Auditor roles tied to engineering, computer science, or information technology SOC codes often qualify for the 24-month STEM OPT extension. Confirm your degree is on the STEM Designated Degree Program List before applying, since this significantly extends your authorization window.
Address OPT proactively in your application
Many employers filter out candidates who seem unclear about their work authorization. State your OPT status and end date confidently in cover letters. Emphasize that no visa petition is required from them during your OPT period, which removes the biggest hiring barrier upfront.
Pursue roles with compliance or regulatory focus
QA Auditor positions in regulated industries like pharmaceuticals, medical devices, and aerospace are more likely to sponsor H-1B visas after OPT. These employers already navigate complex regulatory environments, so they're more comfortable with immigration paperwork than general technology or retail companies.
Get your EAD card in hand before your start date
You cannot begin work as a QA Auditor until your EAD card physically arrives, even if USCIS has approved your OPT application. Apply at least 90 days before your program end date to avoid gaps between graduation and your employment start date.
Quality Assurance Auditor OPT: Frequently Asked Questions
Can F-1 OPT students work as Quality Assurance Auditors?
Yes. Quality Assurance Auditor roles typically qualify as specialty occupations because they require at least a bachelor's degree in a specific technical field such as engineering, computer science, or quality management. As long as your degree aligns with the position's requirements and your EAD card is active, you're authorized to work in this role during your OPT period.
Do Quality Assurance Auditor jobs qualify for the STEM OPT extension?
Many do, but it depends on the SOC code your employer uses for the position and whether your degree appears on the STEM Designated Degree Program List. QA roles tied to engineering, information technology, or computer science SOC codes commonly qualify. Confirm the SOC code with your employer and check with your DSO before assuming eligibility. The extension adds 24 months to your standard 12-month OPT period.
Which industries hire OPT students for Quality Assurance Auditor roles?
Pharmaceuticals, medical devices, aerospace, automotive, software, and electronics manufacturing are the most active industries for this role. Regulated industries tend to have formal QA departments and established processes for hiring international candidates. Browse open Quality Assurance Auditor positions on Migrate Mate, which filters specifically for employers open to OPT and visa sponsorship candidates.
What does OPT reporting look like for Quality Assurance Auditor positions?
You must report your employment to your DSO within 10 days of starting work. Required details include your employer's name, address, and the start date of your position. During STEM OPT, your employer must also enroll in E-Verify, provide a formal training plan using Form I-983, and conduct evaluations at the 12-month and 24-month marks. Missing these reporting deadlines can jeopardize your immigration status.
Are Quality Assurance Auditor employers likely to sponsor H-1B visas after OPT?
Employers in regulated industries such as pharmaceuticals, aerospace, and medical devices sponsor H-1B visas for QA roles at higher rates than most sectors. These companies are accustomed to compliance-heavy processes, and quality assurance functions are difficult to offshore, which increases sponsorship willingness. Targeting employers in these sectors during your OPT search gives you the best chance of a long-term immigration pathway.