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503B Jobs (NOW HIRING)

Tailstorm Health Inc

Pharmacist

Chandler, AZ · On-site

$120K - $150K/yr

Minimum 2-3 years of experience in sterile compounding, manufacturing pharmacy, or 503B facility * Strong understanding of USP , USP , cGMP, and FDA manufacturing guidelines * Strong documentation ...

Barupon LLC

Sterile Compounding Pharmacist

Irvine, CA · On-site

$115K - $135K/yr

Minimum 1-2 years of experience in sterile compounding (hospital, 503B, or outpatient setting) * Knowledge of USP , , and cleanroom protocols * Strong attention to detail and commitment to patient ...

Barupon LLC

Sterile Compounding Pharmacist

Irvine, CA · On-site

$62.50 - $75.25/hr

Minimum 1-2 years of experience in sterile compounding (hospital, 503B, or outpatient setting) * Knowledge of USP , , and cleanroom protocols * Strong attention to detail and commitment to patient ...

Medivant Healthcare

Pharmacist

Chandler, AZ · On-site

$59.50 - $71.50/hr

Minimum 2-3 years of experience in sterile compounding, manufacturing pharmacy, or 503B facility * Strong understanding of USP 797, USP 800, cGMP, and FDA manufacturing guidelines * Strong ...

JobRx, Inc.

Director, Formulation Development

Houston, TX · On-site

$120 - $150/hr

... 503B portfolio, directly influencing product quality, regulatory compliance, operational scalability, and revenue growth. This leader owns formulation development from concept through transfer ...

BaRupOn LLC

Sterile Compounding Pharmacist

Irvine, CA · On-site

$115K - $135K/yr

Minimum 1-2 years of experience in sterile compounding (hospital, 503B, or outpatient setting) * Knowledge of USP , , and cleanroom protocols * Strong attention to detail and commitment to patient ...

Empower Pharmacy

Quality Operations Technician

Houston, TX · On-site

$17.25 - $23.25/hr

As the nation's most advanced 503A compounding pharmacy and FDA-registered 503B outsourcing facility, we're redefining what's possible in personalized medicine and pharmaceutical manufacturing. We're ...

Medivant Healthcare

Pharmacist

Phoenix, AZ · On-site

$57.75 - $69.50/hr

Minimum 2-3 years of experience in sterile compounding, manufacturing pharmacy, or 503B facility * Strong understanding of USP , USP , cGMP, and FDA manufacturing guidelines * Strong documentation ...

MLee Medical Employment

Sterile Pharmacist

Austin, TX · On-site

$57.75 - $69.25/hr

Whether in patient-specific ( 503A ) or bulk manufacturing ( 503B ) workflows, you will apply cGMP ( Current Good Manufacturing Practice ) principles to ensure product quality. Technical Core ...

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503B information

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How much do 503b jobs pay per hour?

As of Aug 12, 2026, the average hourly pay for 503b in the United States is $20.91, according to ZipRecruiter salary data. Most workers in this role earn between $16.35 and $20.67 per hour, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as a 503B outsourcing facility pharmacist, and why are they important?

To thrive as a 503B Outsourcing Facility Pharmacist, you need a Doctor of Pharmacy (PharmD) degree, state licensure, and expertise in sterile compounding and current Good Manufacturing Practices (cGMP). Familiarity with compounding automation systems, environmental monitoring tools, and regulatory compliance software is crucial. Attention to detail, strong organizational skills, and effective communication are vital soft skills for ensuring operational efficiency and regulatory adherence. These competencies are essential to maintain product safety, regulatory compliance, and high-quality pharmaceutical production in a highly regulated environment.

What is the difference between 503B vs 503A?

Aspect503B503A
CertificationsPharmacist, FDA compliancePharmacist, state board licensing
Work EnvironmentOutsourced sterile compounding facilitiesIn-house pharmacy compounding
Regulatory OversightFDA regulatedState pharmacy boards
Industry UsageLarge-scale, outsourcing pharmaciesCommunity and hospital pharmacies

503B facilities operate under FDA regulations, focusing on large-scale sterile compounding outside traditional pharmacies, often serving multiple healthcare providers. In contrast, 503A pharmacies are typically local, in-house pharmacies complying with state pharmacy laws. Both roles require pharmacy credentials but differ mainly in regulatory oversight and operational scope.

What are some common challenges faced by professionals working in a 503B outsourcing facility?

Professionals in 503B outsourcing facilities often encounter challenges related to maintaining strict compliance with FDA regulations, especially regarding Current Good Manufacturing Practice (cGMP) standards. The work environment is highly regulated, requiring meticulous documentation and quality assurance to ensure patient safety. Additionally, there may be frequent audits and inspections, which require staff to stay up-to-date with evolving regulatory requirements. Collaboration with quality assurance, regulatory, and pharmacy teams is essential to address compliance issues and improve operational efficiency.

What is a 503B facility?

A 503B facility refers to an outsourcing pharmacy registered with the U.S. Food and Drug Administration (FDA) under section 503B of the Federal Food, Drug, and Cosmetic Act. These facilities are allowed to compound large batches of medications, typically sterile drugs, in advance of receiving prescriptions, and can distribute them to healthcare facilities nationwide. 503B facilities must adhere to strict quality standards and are subject to regular FDA inspections to ensure safety and compliance. This designation helps hospitals and clinics obtain ready-to-use compounded medications, especially during drug shortages.

How to become a 503B?

A 503B refers to a compound outsourcing facility registered with the FDA that compiles sterile compounded medications. To become a 503B facility, companies must meet specific regulatory requirements, including Good Manufacturing Practices (GMP), and register with the FDA. For individuals seeking employment, relevant skills include pharmaceutical compounding, quality assurance, and compliance knowledge, often supported by certifications in pharmacy or sterile compounding.
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503B jobs near you
Infographic showing various 503B job openings in the United States as of August 2026, with employment types broken down into 91% Full Time, 6% Part Time, 1% Contract, and 2% Nights. Highlights an 84% Physical, 1% Hybrid, and 15% Remote job distribution, with an average salary of $43,499 per year, or $20.9 per hour.

Regulatory Affairs Specialist (FDA, DEA )

BaRupOn LLC

Irvine, CA • On-site

$60K - $76K/yr

Full-time

Medical, Dental, Vision, Retirement, PTO

Re-posted 4 days ago

Job description

Job Summary

The Regulatory Affairs Specialist (FDA, DEA) will ensure BaRupOn's pharmacy, manufacturing, and healthcare operations meet all applicable regulatory requirements. This position is responsible for preparing submissions, maintaining licenses, coordinating audits, and staying ahead of evolving federal and state regulations related to pharmaceuticals, medical devices, and controlled substances.

Key Responsibilities
  • Prepare and manage FDA submissions (e.g., drug listings, establishment registrations, 503A/503B updates)
  • Oversee and renew DEA registrations, inventory records, and security documentation
  • Maintain state pharmacy, medical device, and wholesale distribution licenses
  • Track regulatory changes affecting compounding, controlled substances, and labeling requirements
  • Support internal audits, site inspections, and responses to 483s or warning letters
  • Coordinate with Quality Assurance on SOP compliance, change controls, and deviation reports
  • Serve as point of contact with federal and state regulatory agencies
  • Document and file compliance records and ensure timely reporting
Qualifications
  • Associate degree in Life Sciences, Regulatory Affairs, or related field (Bachelor's preferred)
  • 24 years of regulatory or compliance experience in pharmaceuticals, biotech, or medical devices
  • Working knowledge of FDA regulations (21 CFR Parts 210, 211, 820) and DEA requirements
  • Strong writing, documentation, and organizational skills
  • Familiarity with electronic submission systems, labeling requirements, and drug master files
Preferred Skills
  • Experience in sterile or non-sterile compounding (503A or 503B environments)
  • Knowledge of NABP license portals, MedWatch reporting, or REMS programs
  • Regulatory Affairs Certification (RAC) or DEA compliance training (preferred)
  • Experience responding to FDA inspections, audits, or state pharmacy board requests
Benefits
  • Health, dental, and vision insurance
  • 401(k) with employer match
  • Paid time off and holidays
  • Regulatory training and continuing education support
  • Advancement opportunities into QA/RA leadership roles