Green Card Quality Control Specialist Jobs
Quality Control Specialist roles qualify for EB-2 and EB-3 green card sponsorship through PERM labor certification, which requires employers to document that no qualified U.S. worker is available. Manufacturing, pharmaceuticals, and food production are consistent sponsoring industries. Your degree field and years of inspection or compliance experience determine whether you file under EB-2 or EB-3.
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Get Access To All JobsNATURE AND SCOPE
This Director Quality Control is a member of the Quality Assurance team and is responsible for leading all laboratory activities in support of manufacturing and R&D. This position is responsible for leading the analytical, microbiology and environmental monitoring activities for a multi-site sterile manufacturing operation.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
- Manage the day-to-day activities in the laboratories in support of both operations and R&D functions as well as Environmental Monitoring Technicians in manufacturing at New Albany and Hilliard manufacturing Facilities.
- Manage testing programs including analytical, sterility, bioburden and microbiological tests as necessary.
- Manage, identify and introduce new testing methodologies for applicable testing procedures.
- Manage and perform trend analysis for all operations.
- Provide support in front of regulatory agencies eg: FDA/ CDER-CBER, customer audits, corporate auditors, Health Canada, EMA, internal audits and as required.
- Supervise the certification of laboratory technicians on various test procedures per USP, FDA, PDA and EU guidelines.
- Hire, train and manage performance of existing and future laboratory personnel and technicians.
- Write, review, and approve validation and qualification SOPs.
- Provide expertise in EMPQ qualifications, new sterile filler qualifications, new water systems qualifications, new laboratory space qualifications and disinfectant study qualifications.
- Ensure laboratories maintain compliance with cGMPs/GLPs, support validation, regulatory filing, R&D, Metrology, Engineering, QA, manufacturing and formulation operations.
- Identify, evaluate, purchase and qualify laboratory equipment.
- Direct, perform and resolve out-of-specification investigations, deviations and implement CAPAs.
- Have knowledge of and support the Sterility Assurance Utilities process, Cleaning & Disinfection process and Traffic & Gowning process of sterile manufacturing.
- Train, coach, mentor and supervise direct reports.
- Oversee, troubleshoot and investigate outsourced testing for products and components.
- Partner with Production, Regulatory Affairs, Engineering, and QA Compliance to strategize and organize implementation of new technology, processes, and products.
- Identify and facilitate process improvements to increase efficiencies in systems, operations, and personnel.
- Ensure all work is performed and documented in accordance with existing Company policies and procedures, as well as cGMP and health and safety requirements.
- Position has responsibilities at multiple locations in central Ohio and provide input, as requested, with ARI Shirley, NY on microbiology issues.
- Perform any other tasks/duties as assigned by management.
EDUCATION REQUIREMENTS AND 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.
- Bachelors in Life Sciences required at Minimum. Advanced Degree in preferred.
- Minimum of 12 years of experience in pharmaceutical manufacturing industry required.
- Minimum 8 years management experience required. Exceptions may be considered for outstanding candidates with proven expertise.
- Experience with Trackwise for Deviations, CAPAs and CR process.
- Experience with Lighthouse, or equivalent, environmental monitoring systems, including implementation and operation.
- Experience with method development, in microbiology and/or analytical methods is desired.
- Demonstrated expertise managing cGMP laboratory.
- Strong knowledge of contamination control, disinfection, microbiology, sterility assurance, aseptic processing, cGMPs and regulatory requirements.
- Strong knowledge of MS-Office software and PC Skills required.
- Excellent leadership, communication, organizational, interpersonal and communication skills (oral and written).
- Proven record of people and program management skills.
- Ability to work independently and deliver timely results.
- Ability to work off hours and weekends as needed.
PHYSICAL ENVIRONMENT AND REQUIREMENTS
- Employee must be able to occasionally lift and/or move up to 25 pounds.
- Physically able to wear laboratory protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. PPE and Respirators are essential for the health and safety of employees.
American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.
Applicants have rights under Federal Employment Laws.
- FMLA poster: https://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdf
- Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov)
- Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf
Alert: We’re aware of individuals impersonating our staff to target job seekers. Please note:
- All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address.
- Our recruiting process includes multiple in person and/or video interviews and assessments.
- If you are unsure about the legitimacy of a message, contact John Rossini at jrossini@americanregent.com before responding.
- We never request payment, bank information, or personal financial details during our offer process.
Your security is important to us, and we encourage you to stay vigilant when job searching.
American Regent Inc. endeavors to make https://careers.americanregent.com/ accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email hrtalentacquisition@americanregent.com.
NATURE AND SCOPE
This Director Quality Control is a member of the Quality Assurance team and is responsible for leading all laboratory activities in support of manufacturing and R&D. This position is responsible for leading the analytical, microbiology and environmental monitoring activities for a multi-site sterile manufacturing operation.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
- Manage the day-to-day activities in the laboratories in support of both operations and R&D functions as well as Environmental Monitoring Technicians in manufacturing at New Albany and Hilliard manufacturing Facilities.
- Manage testing programs including analytical, sterility, bioburden and microbiological tests as necessary.
- Manage, identify and introduce new testing methodologies for applicable testing procedures.
- Manage and perform trend analysis for all operations.
- Provide support in front of regulatory agencies eg: FDA/ CDER-CBER, customer audits, corporate auditors, Health Canada, EMA, internal audits and as required.
- Supervise the certification of laboratory technicians on various test procedures per USP, FDA, PDA and EU guidelines.
- Hire, train and manage performance of existing and future laboratory personnel and technicians.
- Write, review, and approve validation and qualification SOPs.
- Provide expertise in EMPQ qualifications, new sterile filler qualifications, new water systems qualifications, new laboratory space qualifications and disinfectant study qualifications.
- Ensure laboratories maintain compliance with cGMPs/GLPs, support validation, regulatory filing, R&D, Metrology, Engineering, QA, manufacturing and formulation operations.
- Identify, evaluate, purchase and qualify laboratory equipment.
- Direct, perform and resolve out-of-specification investigations, deviations and implement CAPAs.
- Have knowledge of and support the Sterility Assurance Utilities process, Cleaning & Disinfection process and Traffic & Gowning process of sterile manufacturing.
- Train, coach, mentor and supervise direct reports.
- Oversee, troubleshoot and investigate outsourced testing for products and components.
- Partner with Production, Regulatory Affairs, Engineering, and QA Compliance to strategize and organize implementation of new technology, processes, and products.
- Identify and facilitate process improvements to increase efficiencies in systems, operations, and personnel.
- Ensure all work is performed and documented in accordance with existing Company policies and procedures, as well as cGMP and health and safety requirements.
- Position has responsibilities at multiple locations in central Ohio and provide input, as requested, with ARI Shirley, NY on microbiology issues.
- Perform any other tasks/duties as assigned by management.
EDUCATION REQUIREMENTS AND 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.
- Bachelors in Life Sciences required at Minimum. Advanced Degree in preferred.
- Minimum of 12 years of experience in pharmaceutical manufacturing industry required.
- Minimum 8 years management experience required. Exceptions may be considered for outstanding candidates with proven expertise.
- Experience with Trackwise for Deviations, CAPAs and CR process.
- Experience with Lighthouse, or equivalent, environmental monitoring systems, including implementation and operation.
- Experience with method development, in microbiology and/or analytical methods is desired.
- Demonstrated expertise managing cGMP laboratory.
- Strong knowledge of contamination control, disinfection, microbiology, sterility assurance, aseptic processing, cGMPs and regulatory requirements.
- Strong knowledge of MS-Office software and PC Skills required.
- Excellent leadership, communication, organizational, interpersonal and communication skills (oral and written).
- Proven record of people and program management skills.
- Ability to work independently and deliver timely results.
- Ability to work off hours and weekends as needed.
PHYSICAL ENVIRONMENT AND REQUIREMENTS
- Employee must be able to occasionally lift and/or move up to 25 pounds.
- Physically able to wear laboratory protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. PPE and Respirators are essential for the health and safety of employees.
American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.
Applicants have rights under Federal Employment Laws.
- FMLA poster: https://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdf
- Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov)
- Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf
Alert: We’re aware of individuals impersonating our staff to target job seekers. Please note:
- All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address.
- Our recruiting process includes multiple in person and/or video interviews and assessments.
- If you are unsure about the legitimacy of a message, contact John Rossini at jrossini@americanregent.com before responding.
- We never request payment, bank information, or personal financial details during our offer process.
Your security is important to us, and we encourage you to stay vigilant when job searching.
American Regent Inc. endeavors to make https://careers.americanregent.com/ accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email hrtalentacquisition@americanregent.com.
See all 336+ Green Card Quality Control Specialist Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new Green Card Quality Control Specialist Jobs.
Get Access To All JobsTips for Finding Green Card Sponsorship as a Quality Control Specialist
Match your credentials to the right EB category
EB-3 covers Quality Control Specialists with a bachelor's degree in a relevant field like chemistry, engineering, or food science. If you hold a master's degree or have an advanced-degree professional profile, target EB-2 roles specifically written to require that level.
Document industry-specific certifications before applying
Certifications like ASQ CQE or ISO 9001 lead auditor credentials strengthen your PERM labor market test position. Employers advertising these as minimum requirements can use them to narrow the U.S. applicant pool, which directly supports your green card case.
Target manufacturers and pharma companies with PERM history
Search DOL's OFLC Wage Search and PERM disclosure data to find employers who have previously filed for Quality Control roles. Repeat PERM filers understand the process, which shortens your internal HR negotiation and reduces filing errors.
Use Migrate Mate to find verified sponsoring employers
Filter by Quality Control Specialist roles with active green card sponsorship history using Migrate Mate. This surfaces employers who have completed PERM filings for similar positions, so you're not guessing which companies will commit to the full EB-2 or EB-3 process.
Clarify the prevailing wage tier during your offer negotiation
PERM requires your offered salary to meet DOL prevailing wage levels, set by the OFLC Wage Search tool at one of four tiers. Ask your prospective employer which tier they plan to file at before signing an offer letter, since a lower tier can complicate your case.
Confirm your employer will file I-140 concurrently when possible
Once USCIS approves PERM, concurrent I-140 filing is allowed and shortens overall timelines. Ask HR or outside counsel whether they plan to file I-140 immediately after PERM certification, since delays between stages can push your priority date back unnecessarily.
Green Card Quality Control Specialist: Frequently Asked Questions
Do Quality Control Specialist roles qualify for EB-2 or EB-3 green card sponsorship?
Most Quality Control Specialist positions qualify under EB-3, which covers skilled workers and professionals with a bachelor's degree. Roles requiring a master's degree in a specialized field like pharmaceutical sciences or advanced materials testing may qualify under EB-2. Your employer's job description and the minimum education requirement stated in the PERM filing determine which category applies.
How does green card sponsorship differ from H-1B sponsorship for this role?
Green card sponsorship through PERM is permanent and not subject to an annual lottery. H-1B visa sponsorship is temporary, capped at 85,000 per year, and requires lottery selection. For Quality Control Specialist roles, EB-3 PERM filings have no cap, so once your employer completes the labor certification and USCIS approves the I-140, your place in line is set by priority date rather than luck.
How long does the EB-3 PERM process take for a Quality Control Specialist?
PERM labor certification currently takes roughly six to eighteen months depending on DOL analyst review queues, which you can track on the OFLC processing times page. After PERM is certified, your employer files the I-140 petition with USCIS. If your priority date is current, adjustment of status or consular processing follows. Total timelines from PERM filing to green card approval commonly run two to four years for most nationalities.
What industries most commonly sponsor Quality Control Specialists for green cards?
Pharmaceutical manufacturing, medical device companies, food and beverage producers, and automotive parts suppliers file PERM applications for Quality Control Specialists most frequently. These industries rely on specialized inspection and compliance knowledge that meets DOL's minimum requirements for labor market testing. You can verify an employer's sponsorship history by reviewing OFLC PERM disclosure data before applying.
Where can I find Quality Control Specialist jobs that offer green card sponsorship?
Migrate Mate filters job listings by employers with verified green card sponsorship history, so you can focus on Quality Control Specialist roles where companies have already completed PERM filings for similar positions. Searching this way avoids applying to employers who have no experience with EB-2 or EB-3 sponsorship, which is one of the most common reasons green card timelines stall or collapse after an offer is made.