OPT Quality Assurance Associate Jobs
Quality Assurance Associate roles are a strong fit for F-1 OPT students with degrees in computer science, engineering, or information systems. Most positions qualify as STEM OPT extensions, giving you up to 36 months of work authorization. Employers in software, manufacturing, and healthcare regularly hire QA associates without requiring prior H-1B visa sponsorship commitments.
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Get Access To All JobsCordenPharma is a leading full-service Contract Development and Manufacturing Organization (CDMO) specializing in active pharmaceutical ingredients (APIs), excipients, drug products (DPs), and packaging. With around 3,000 employees worldwide, we help pharmaceutical and biotech companies manufacture medicines with the ultimate goal of improving people’s lives.
Our network, spanning Europe and the U.S., provides flexible and specialized solutions across six technology platforms: Peptides, Lipids & Carbohydrates, Injectables, Highly Potent & Oncology, Small Molecules, and Oligonucleotides. We strive for excellence in supporting this network and are committed to delivering the highest quality products for patient well-being.
OUR PEOPLE VISION
We strive for excellence. We share our passion. Together, we make a difference in patients' lives.
SUMMARY
Administers Quality Assurance programs, procedures, and controls ensuring that performance and quality of products conform to established Corden standards and federal regulations. Works directly with manufacturing and support groups to address quality issues with cGMP activities. Participates in validation activities related to processes and computer-related systems, as well as general QA areas of responsibility.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Include the following. Other duties may be assigned.
- Reviewing Validation, Qualification, and Change Control Documents for adequacy and adherence to cGMPs and Corden SOPs
- Acting as the QA Representative on project teams as needed
- Is the QA Generalist and resource on cGMP issues, who understands cGMP, Data Integrity, and GDP requirements and expectations
- Participate in customer audits and regulatory inspections, which may include defending systems, formulating responses, or owning associated CAPA records
- Reviews completed/executed batch records in support of lot release
- Compiles supporting data/information for lot release
- Issues batch records and associated labels, by ensuring the copy is a replicate of the master production instructions for each intermediate and API
- Reviews and approves stability reports, SOP/document revisions, methods, specifications, validation documents, and miscellaneous cGMP documents that require QA approval
- Serves as the backup Administrator for the QA Documentation Specialist of the Quality Department, which includes managing the records database (TabFusion) and off-site records storage (Iron Mountain)
- Serves as overall back up to other Quality personnel as appropriate
LEADERSHIP & BUDGET RESPONSIBILITIES
Provides guidance and leadership where appropriate, based upon the results of the documentation review process. Responsible for participating in the budget process for input as required.
SAFETY & ENVIRONMENTAL RESPONSIBILITIES
Every individual is personally responsible for the safety and environmental aspects of his or her activities in the workplace. Each employee is expected to perform their job duties in a safe manner utilizing all their knowledge, training, ability, and experience.
QUALITY RESPONSIBILITIES
Corden Pharma Colorado (CPC) is a manufacturer of a variety of pharmaceutical products. In following Current Good Manufacturing Practices (cGMP), Corden Pharma Colorado manufactures in accordance with the US Food and Drug Administration (FDA), International Council for Harmonisation Q7 (ICH), and other global regulations as applicable. This is critical as it is our mission to not place patients at risk due to inadequate safety, quality, or efficacy. CPC’s Quality Management System, which incorporates cGMP, is designed to deliver this quality objective. Attainment is produced through the requisite participation and commitment of all staff across departments and at all levels within the company.
cGMP is the part of Quality Management System ensuring products are consistently produced to accurate quality standards. Adherence to clearly defined procedures, in compliance with the principles of cGMP, is required when performing operations across Corden Pharma Colorado.
QUALIFICATIONS
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Knowledge of cGMPs, GDPs, and Corden Quality SOPs, and guidelines as they apply to documentation protocol and validation activities
- Knowledge of process protocols, batch record requirements, and deviation reporting adequacy
- Ability to apply attention to detail and regulatory requirements; and a practical, defendable, and logical approach to problem solving
EDUCATION and/or EXPERIENCE
Bachelor's Degree (BA) from 4-year college or university; or 2 years Pharmaceutical Manufacturing experience in a technical support or production role; or equivalent combination of education and experience.
LANGUAGE SKILLS
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public. Ability to speak, read, and write in English.
MATHEMATICAL SKILLS
Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
REASONING ABILITY
Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form, and deal with several abstract and concrete variables.
CERTIFICATES, LICENSES, REGISTRATIONS
None.
PHYSICAL DEMANDS
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand, walk, and sit. The employee is occasionally required to work with hands; reach above shoulder height; climb or balance; stoop, kneel, crouch, or crawl; and taste or smell. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, depth perception, and ability to adjust focus.
WORK ENVIRONMENT
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is occasionally exposed to wet and/or humid conditions, moving mechanical parts, and outside weather conditions. The noise level in the work environment is usually moderate.
CORE COMPETENCIES
These are the specific areas of knowledge, skill and ability that are important for successful job performance. They must be job related and consistent with business necessity.
- Knowledgeable of federal and corporate regulations; Chemical Manufacturing; Good Manufacturing Practices and Good Documentation Practices regulations and interpretations
- Willing to work different shifts
- Computer related experience
- Process, computer, and equipment validation experience
SALARY
Actual pay will be based on your skills and experience.
BENEFITS
- 401(k) matching - Corden Pharma will contribute 100% of the first 6% - 100% vested after 2 years of service
- Accident Plan
- Critical Illness Insurance
- Dental Insurance
- Disability Insurance
- Employee Assistance Program
- Flexible Spending Account
- Health Insurance PPO/HSA
- Hospital Indemnity Plan
- ID Theft Protection
- Life Insurance
- Paid Paternal Leave
- Tuition Reimbursement
- Wellness Program
- Vacation – Three Weeks 1st Year
- Vision Insurance
EQUAL OPPORTUNITY EMPLOYER
Corden Pharma 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. Corden Pharma embraces fair hiring practices.
This post will expire June 12, 2026.
CordenPharma is a leading full-service Contract Development and Manufacturing Organization (CDMO) specializing in active pharmaceutical ingredients (APIs), excipients, drug products (DPs), and packaging. With around 3,000 employees worldwide, we help pharmaceutical and biotech companies manufacture medicines with the ultimate goal of improving people’s lives.
Our network, spanning Europe and the U.S., provides flexible and specialized solutions across six technology platforms: Peptides, Lipids & Carbohydrates, Injectables, Highly Potent & Oncology, Small Molecules, and Oligonucleotides. We strive for excellence in supporting this network and are committed to delivering the highest quality products for patient well-being.
OUR PEOPLE VISION
We strive for excellence. We share our passion. Together, we make a difference in patients' lives.
SUMMARY
Administers Quality Assurance programs, procedures, and controls ensuring that performance and quality of products conform to established Corden standards and federal regulations. Works directly with manufacturing and support groups to address quality issues with cGMP activities. Participates in validation activities related to processes and computer-related systems, as well as general QA areas of responsibility.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Include the following. Other duties may be assigned.
- Reviewing Validation, Qualification, and Change Control Documents for adequacy and adherence to cGMPs and Corden SOPs
- Acting as the QA Representative on project teams as needed
- Is the QA Generalist and resource on cGMP issues, who understands cGMP, Data Integrity, and GDP requirements and expectations
- Participate in customer audits and regulatory inspections, which may include defending systems, formulating responses, or owning associated CAPA records
- Reviews completed/executed batch records in support of lot release
- Compiles supporting data/information for lot release
- Issues batch records and associated labels, by ensuring the copy is a replicate of the master production instructions for each intermediate and API
- Reviews and approves stability reports, SOP/document revisions, methods, specifications, validation documents, and miscellaneous cGMP documents that require QA approval
- Serves as the backup Administrator for the QA Documentation Specialist of the Quality Department, which includes managing the records database (TabFusion) and off-site records storage (Iron Mountain)
- Serves as overall back up to other Quality personnel as appropriate
LEADERSHIP & BUDGET RESPONSIBILITIES
Provides guidance and leadership where appropriate, based upon the results of the documentation review process. Responsible for participating in the budget process for input as required.
SAFETY & ENVIRONMENTAL RESPONSIBILITIES
Every individual is personally responsible for the safety and environmental aspects of his or her activities in the workplace. Each employee is expected to perform their job duties in a safe manner utilizing all their knowledge, training, ability, and experience.
QUALITY RESPONSIBILITIES
Corden Pharma Colorado (CPC) is a manufacturer of a variety of pharmaceutical products. In following Current Good Manufacturing Practices (cGMP), Corden Pharma Colorado manufactures in accordance with the US Food and Drug Administration (FDA), International Council for Harmonisation Q7 (ICH), and other global regulations as applicable. This is critical as it is our mission to not place patients at risk due to inadequate safety, quality, or efficacy. CPC’s Quality Management System, which incorporates cGMP, is designed to deliver this quality objective. Attainment is produced through the requisite participation and commitment of all staff across departments and at all levels within the company.
cGMP is the part of Quality Management System ensuring products are consistently produced to accurate quality standards. Adherence to clearly defined procedures, in compliance with the principles of cGMP, is required when performing operations across Corden Pharma Colorado.
QUALIFICATIONS
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Knowledge of cGMPs, GDPs, and Corden Quality SOPs, and guidelines as they apply to documentation protocol and validation activities
- Knowledge of process protocols, batch record requirements, and deviation reporting adequacy
- Ability to apply attention to detail and regulatory requirements; and a practical, defendable, and logical approach to problem solving
EDUCATION and/or EXPERIENCE
Bachelor's Degree (BA) from 4-year college or university; or 2 years Pharmaceutical Manufacturing experience in a technical support or production role; or equivalent combination of education and experience.
LANGUAGE SKILLS
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public. Ability to speak, read, and write in English.
MATHEMATICAL SKILLS
Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
REASONING ABILITY
Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form, and deal with several abstract and concrete variables.
CERTIFICATES, LICENSES, REGISTRATIONS
None.
PHYSICAL DEMANDS
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand, walk, and sit. The employee is occasionally required to work with hands; reach above shoulder height; climb or balance; stoop, kneel, crouch, or crawl; and taste or smell. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, depth perception, and ability to adjust focus.
WORK ENVIRONMENT
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is occasionally exposed to wet and/or humid conditions, moving mechanical parts, and outside weather conditions. The noise level in the work environment is usually moderate.
CORE COMPETENCIES
These are the specific areas of knowledge, skill and ability that are important for successful job performance. They must be job related and consistent with business necessity.
- Knowledgeable of federal and corporate regulations; Chemical Manufacturing; Good Manufacturing Practices and Good Documentation Practices regulations and interpretations
- Willing to work different shifts
- Computer related experience
- Process, computer, and equipment validation experience
SALARY
Actual pay will be based on your skills and experience.
BENEFITS
- 401(k) matching - Corden Pharma will contribute 100% of the first 6% - 100% vested after 2 years of service
- Accident Plan
- Critical Illness Insurance
- Dental Insurance
- Disability Insurance
- Employee Assistance Program
- Flexible Spending Account
- Health Insurance PPO/HSA
- Hospital Indemnity Plan
- ID Theft Protection
- Life Insurance
- Paid Paternal Leave
- Tuition Reimbursement
- Wellness Program
- Vacation – Three Weeks 1st Year
- Vision Insurance
EQUAL OPPORTUNITY EMPLOYER
Corden Pharma 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. Corden Pharma embraces fair hiring practices.
This post will expire June 12, 2026.
See all 364+ OPT Quality Assurance Associate Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new OPT Quality Assurance Associate Jobs.
Get Access To All JobsTips for Finding OPT Sponsorship as a Quality Assurance Associate
Target STEM-designated employers first
QA Associate roles at software and tech companies almost always qualify for the 24-month STEM OPT extension. Prioritize employers with an active E-Verify enrollment, which is required for STEM OPT and signals they have a process for international students.
Frame your degree as a direct qualifier
Hiring managers often assume QA is purely experience-based. Connect your computer science, engineering, or information systems degree directly to the role by mentioning coursework in software testing, systems analysis, or quality methods in your cover letter and resume.
Highlight testing tools and methodologies upfront
QA hiring decisions move fast. Put tools like Selenium, JIRA, TestRail, or Postman in your resume summary, not buried in a skills section. Employers scanning for technical fit need to see your toolkit before deciding whether to sponsor your continued authorization.
Ask about OPT early, but frame it correctly
Raise your work authorization status before the offer stage, not after. Say you are currently authorized on OPT and eligible for a STEM extension, which requires E-Verify enrollment. This gives employers a concrete, low-cost action rather than an open-ended sponsorship commitment.
Use your training plan to demonstrate structure
STEM OPT requires a formal training plan with your employer. Present this proactively as a benefit. Employers see it as a structured onboarding framework, not a burden. QA roles map naturally to measurable learning objectives, making the plan easy to complete.
Focus on industries with high QA hiring volume
Software, medical devices, pharmaceuticals, and aerospace all have compliance-driven QA needs and are accustomed to sponsoring international employees. These industries hire QA associates in volume and are more likely to have established immigration processes already in place.
Quality Assurance Associate OPT: Frequently Asked Questions
Does a Quality Assurance Associate role qualify for the STEM OPT extension?
Most QA Associate positions qualify for the 24-month STEM OPT extension if your degree is in a STEM-designated field such as computer science, engineering, or information systems. The role must be directly related to your degree, and your employer must be enrolled in E-Verify. Review your job offer against your degree field before assuming automatic eligibility.
Where can I find Quality Assurance Associate jobs that are open to OPT students?
Migrate Mate is built specifically for F-1 OPT students and filters jobs by visa sponsorship willingness, so you are not wasting applications on employers who will not consider international candidates. Browsing QA roles on Migrate Mate lets you focus on companies already familiar with OPT work authorization requirements.
Do Quality Assurance Associate employers typically sponsor H-1B visas after OPT?
It varies by employer size and industry. Large software companies, medical device manufacturers, and aerospace firms with established HR and legal teams are more likely to sponsor H-1B visa petitions for QA associates they have invested in training. Smaller companies may not have the infrastructure. Asking about long-term visa support during the offer stage is reasonable and expected.
What degree fields count as STEM-eligible for a QA Associate role?
Computer science, electrical engineering, mechanical engineering, industrial engineering, information systems, and applied mathematics are all commonly STEM-designated fields that support a QA Associate STEM OPT extension. Your specific degree program must appear on the DHS STEM Designated Degree Program List, which your Designated School Official can confirm before you accept an offer.
How much time does it take to get STEM OPT approved for a QA Associate job?
You must file your STEM OPT extension application with USCIS at least 90 days before your initial OPT expires. USCIS standard processing takes two to five months, so starting early is essential. If approved on time, you receive a 180-day automatic cap-gap period that keeps you work-authorized while the application is pending. Premium processing is not available for OPT extensions.