Site Director
$120K - $150K/yr
Minimum 5+ years of leadership specifically within a 503A or 503B Outsourcing Facility (absolute requirement). * Technical Expertise: Deep knowledge of aseptic processing and sterile injectable ...
Quick apply
Site Director
$120K - $150K/yr
Minimum 5+ years of leadership specifically within a 503A or 503B Outsourcing Facility (absolute requirement). * Technical Expertise: Deep knowledge of aseptic processing and sterile injectable ...
Sterile Compounding Pharmacist
Irvine, CA · On-site
$115K - $135K/yr
Minimum 12 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 ...
Quick apply
Sterile Compounding Pharmacist
Irvine, CA · On-site
$115K - $135K/yr
Minimum 12 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 ...
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 ...
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 ...
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 ...
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 ...
Quality Specialist
Los Alamitos, CA · On-site
$70K - $85K/yr
The Quality Specialist is an individual contributor within the site Quality Unit, supporting Quality activities in a sterile injectable cGMP / 503B environment. The role executes day-to-day quality ...
Quality Specialist
Los Alamitos, CA · On-site
$70K - $85K/yr
The Quality Specialist is an individual contributor within the site Quality Unit, supporting Quality activities in a sterile injectable cGMP / 503B environment. The role executes day-to-day quality ...
Regulatory Affairs Specialist (FDA, DEA )
Irvine, CA · On-site
$60K - $76K/yr
Prepare and manage FDA submissions (e.g., drug listings, establishment registrations, 503A/503B updates) * Oversee and renew DEA registrations, inventory records, and security documentation
Regulatory Affairs Specialist (FDA, DEA )
Irvine, CA · On-site
$60K - $76K/yr
Prepare and manage FDA submissions (e.g., drug listings, establishment registrations, 503A/503B updates) * Oversee and renew DEA registrations, inventory records, and security documentation
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 ...
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 ...
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 ...
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 ...
This role sits at the intersection of Quality, IT, Manufacturing, and Operations , translating cGMP, 503B, and data integrity requirements into a scalable, user-friendly document management solution ...
This role sits at the intersection of Quality, IT, Manufacturing, and Operations , translating cGMP, 503B, and data integrity requirements into a scalable, user-friendly document management solution ...
Regulatory Affairs Specialist (FDA, DEA )
Irvine, CA · On-site
$60K - $76K/yr
Prepare and manage FDA submissions (e.g., drug listings, establishment registrations, 503A/503B updates) * Oversee and renew DEA registrations, inventory records, and security documentation
Quick apply
Regulatory Affairs Specialist (FDA, DEA )
Irvine, CA · On-site
$60K - $76K/yr
Prepare and manage FDA submissions (e.g., drug listings, establishment registrations, 503A/503B updates) * Oversee and renew DEA registrations, inventory records, and security documentation
Regulatory Affairs Specialist (FDA, DEA )
Irvine, CA · On-site
$60K - $76K/yr
Prepare and manage FDA submissions (e.g., drug listings, establishment registrations, 503A/503B updates) * Oversee and renew DEA registrations, inventory records, and security documentation
Regulatory Affairs Specialist (FDA, DEA )
Irvine, CA · On-site
$60K - $76K/yr
Prepare and manage FDA submissions (e.g., drug listings, establishment registrations, 503A/503B updates) * Oversee and renew DEA registrations, inventory records, and security documentation
Learning Lead, Aseptic Processing
Los Alamitos, CA · On-site
$38 - $43/hr
Maintain up-to-date training records and documentation in compliance with FDA 503A/503B requirements and USP guidelines. * Stay current on regulatory changes and integrate new industry best practices ...
Learning Lead, Aseptic Processing
Los Alamitos, CA · On-site
$38 - $43/hr
Maintain up-to-date training records and documentation in compliance with FDA 503A/503B requirements and USP guidelines. * Stay current on regulatory changes and integrate new industry best practices ...
Senior Formulation Scientist, Sterile & Peptide Product Development
Los Alamitos, CA · On-site
$150 - $210/hr
... FDA 503B requirements. This is a senior technical role with room to shape formulation strategy, mentor junior scientists, and help expand our sterile and peptide portfolio. You Will: * Lead ...
Senior Formulation Scientist, Sterile & Peptide Product Development
Los Alamitos, CA · On-site
$150 - $210/hr
... FDA 503B requirements. This is a senior technical role with room to shape formulation strategy, mentor junior scientists, and help expand our sterile and peptide portfolio. You Will: * Lead ...
Senior Formulation Scientist, Sterile & Peptide Product Development
Los Alamitos, CA · On-site
$140K - $180K/yr
... FDA 503B requirements. This is a senior technical role with room to shape formulation strategy, mentor junior scientists, and help expand our sterile and peptide portfolio. You Will: * Lead ...
Senior Formulation Scientist, Sterile & Peptide Product Development
Los Alamitos, CA · On-site
$140K - $180K/yr
... FDA 503B requirements. This is a senior technical role with room to shape formulation strategy, mentor junior scientists, and help expand our sterile and peptide portfolio. You Will: * Lead ...
Senior Formulation Scientist, Sterile & Peptide Product Development
Los Alamitos, CA · On-site
$150 - $210/hr
... FDA 503B requirements. This is a senior technical role with room to shape formulation strategy, mentor junior scientists, and help expand our sterile and peptide portfolio. You Will: * Lead ...
Senior Formulation Scientist, Sterile & Peptide Product Development
Los Alamitos, CA · On-site
$150 - $210/hr
... FDA 503B requirements. This is a senior technical role with room to shape formulation strategy, mentor junior scientists, and help expand our sterile and peptide portfolio. You Will: * Lead ...
Senior Formulation Scientist, Sterile & Peptide Product Development
Los Alamitos, CA · On-site
$190 - $240/hr
... FDA 503B requirements. This is a senior technical role with room to shape formulation strategy, mentor junior scientists, and help expand our sterile and peptide portfolio. You Will: * Lead ...
Senior Formulation Scientist, Sterile & Peptide Product Development
Los Alamitos, CA · On-site
$190 - $240/hr
... FDA 503B requirements. This is a senior technical role with room to shape formulation strategy, mentor junior scientists, and help expand our sterile and peptide portfolio. You Will: * Lead ...
Collaborate with Quality and Regulatory teams to ensure formulation data supports regulatory compliance, including 503A/503B requirements. * Support manufacturing and analytical teams by providing ...
Quick apply
Collaborate with Quality and Regulatory teams to ensure formulation data supports regulatory compliance, including 503A/503B requirements. * Support manufacturing and analytical teams by providing ...
Collaborate with Quality and Regulatory teams to ensure formulation data supports regulatory compliance, including 503A/503B requirements. * Support manufacturing and analytical teams by providing ...
Quick apply
Collaborate with Quality and Regulatory teams to ensure formulation data supports regulatory compliance, including 503A/503B requirements. * Support manufacturing and analytical teams by providing ...
Pharmacy Technician - Sterile IV Compounding
Santa Fe Springs, CA · On-site
$25.17 - $28.09/hr
With experience, capacity, and a passion for safety, CAPS is your 503B solution. Position Summary: The IV Technician I is an entry-level compounding role responsible for assisting in the preparation ...
Pharmacy Technician - Sterile IV Compounding
Santa Fe Springs, CA · On-site
$25.17 - $28.09/hr
With experience, capacity, and a passion for safety, CAPS is your 503B solution. Position Summary: The IV Technician I is an entry-level compounding role responsible for assisting in the preparation ...
Pharmacy Licensing & Credentialing Manager
Irvine, CA · On-site
$60K - $70K/yr
Experience with FDA 503A/503B licensing or outsourcing facility registration * Understanding of CLIA, NABP inspections, or specialty pharmacy credentialing Benefits * Health, dental, and vision ...
Quick apply
Pharmacy Licensing & Credentialing Manager
Irvine, CA · On-site
$60K - $70K/yr
Experience with FDA 503A/503B licensing or outsourcing facility registration * Understanding of CLIA, NABP inspections, or specialty pharmacy credentialing Benefits * Health, dental, and vision ...
503B information
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.
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 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 the difference between 503B vs 503A?
| Aspect | 503B | 503A |
|---|---|---|
| Certifications | Pharmacist, FDA compliance | Pharmacist, state board licensing |
| Work Environment | Outsourced sterile compounding facilities | In-house pharmacy compounding |
| Regulatory Oversight | FDA regulated | State pharmacy boards |
| Industry Usage | Large-scale, outsourcing pharmacies | Community 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.
How to become a 503B?
A 503B refers to a compound outsourcing facility registered with the FDA that compiles with Good Manufacturing Practices. To become a 503B, a facility must register with the FDA, comply with quality standards, and often employ licensed pharmacists and qualified personnel. For individuals, working in a 503B facility typically requires relevant pharmaceutical or healthcare experience and certifications such as pharmacy licensure or quality assurance training.
What are popular job titles related to 503B jobs in California?
For 503B jobs in California, the most frequently searched job titles are:
- Assistant Pharmacy Technician
- High School Pharmacy
- Advanced Pharmacy Technician
- Flex Schedule Jewel Osco Pharmacy Technician
- Entry Pharmacy Technician
- Innovation Compounding Pharmacy
- Part Time Certified Pharmacy Technician
- Self Employed Travel Pharmacy Technician
- Scripts Pharmacy
- Union Hospital Pharmacy Technician
What job categories do people searching 503B jobs in California look for?
The top searched job categories for 503B jobs in California are:
What cities in California are hiring for 503B jobs?
Cities in California with the most 503B job openings:
Job description
Job Description
Strategic Leadership: Spearhead the operations and regulatory requirements of a high-volume peptide compounding facility.
Compliance Integration: Implement and maintain robust cGMP and USP standards.
Production Oversight: Manage end-to-end manufacturing and sterile fill-finish for a dedicated peptide portfolio.
Quality Management: Manage the execution of Quality Management Systems (QMS), including CAPA, deviations, and change control.
Facility Scale-up: Oversee site readiness for rigorous federal and state regulatory inspections, including FDA and 503B.
Requirements
Track Record: Minimum 5+ years of leadership specifically within a 503A or 503B Outsourcing Facility (absolute requirement).
Technical Expertise: Deep knowledge of aseptic processing and sterile injectable requirements.
Quality Credentials: Proven history of leading sites through successful Board of Pharmacy and FDA inspections.
Education: B.S. in Pharmacy, Chemistry, or Life Sciences; advanced degree (PharmD/MBA) preferred.
Leadership: Ability to build and mentor a high-performing technical team in a fast-paced environment.
Background: Engineering background is a plus.
Bilingual: Chinese or Mandarin
About W3Global
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W3Global has been delivering staffing solutions for nearly two decades; we know which recruiting strategies work best. Our expert team is committed to developing a customized solution to fit your company’s unique needs. As a W3Global client, you’ll also receive personalized assistance from a seasoned team of staffing specialists. We are committed to providing both technical support and industry expertise to simplify the hiring process. We know that your time matters. W3Global will help you streamline the hiring process, getting it done and getting it right.
Industry
Recruiting and staffing services
Company size
501 - 1,000 Employees
Headquarters location
Frisco, TX, US
Year founded
2006