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Fda Contractor Jobs in California (NOW HIRING)

Kardion

NPI Buyer

Irvine, CA · On-site

Lead sourcing strategy for new product development, ensuring alignment with FDA 21 CFR 820, ISO ... Prior experience purchasing components for medical technology products and contracting with general ...

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Fda Contractor information

What is an FDA contractor?

An FDA contractor is an individual or company that provides goods or services to the U.S. Food and Drug Administration (FDA) under a formal agreement or contract. These contractors may work in a wide range of areas including research, information technology, regulatory consulting, laboratory services, or facility maintenance. FDA contractors are not direct employees of the FDA but play a crucial role in supporting the agency’s mission to protect public health by ensuring the safety, efficacy, and security of drugs, biological products, and medical devices. Their work is often governed by strict regulations and requires compliance with federal standards. Contractors are selected through a competitive procurement process to ensure quality and value.

What are the key skills and qualifications needed to thrive as an FDA contractor?

To thrive as an FDA Contractor, you need expertise in regulatory compliance, scientific analysis, and project management, often supported by a degree in life sciences or a related field. Familiarity with FDA regulations, electronic submission systems, and specialized software like eCTD or data analysis tools is typically required. Attention to detail, strong communication skills, and adaptability help contractors excel in collaborative and deadline-driven environments. These skills ensure accurate, timely submissions and effective support for FDA regulatory processes.

What are some common challenges faced by FDA contractors when working with cross-functional teams?

FDA Contractors often collaborate with diverse teams, including regulatory, quality assurance, and clinical staff. One common challenge is aligning different priorities and communication styles while ensuring compliance with regulatory standards and tight project deadlines. Success in this role requires strong organizational skills, adaptability, and proactive communication to keep projects moving smoothly and maintain regulatory integrity. Building rapport and understanding the unique needs of each department can help FDA Contractors effectively bridge gaps and facilitate teamwork.

What is the difference between Fda Contractor vs Fda Auditor?

AspectFda ContractorFda Auditor
Required CredentialsTypically requires knowledge of FDA regulations, compliance, and industry standards; certifications like RAC or CQA are commonRequires similar credentials, often with additional auditing certifications such as CQA or ISO auditor training
Work EnvironmentWorks on projects for FDA-regulated companies, often in labs, manufacturing sites, or officesConducts inspections and audits at facilities, often traveling to various sites
Employer & Industry UsageHired by pharmaceutical, biotech, or medical device companies as external consultantsEmployed by regulatory agencies or contracted to perform compliance audits for FDA oversight

In summary, Fda Contractors focus on supporting companies with compliance projects, while Fda Auditors primarily evaluate and verify adherence to FDA regulations through inspections and audits. Both roles require similar certifications and industry knowledge but differ in their primary functions and work settings.

What are popular job titles related to Fda Contractor jobs in California?

For Fda Contractor jobs in California, the most frequently searched job titles are:

What job categories do people searching Fda Contractor jobs in California look for?

The top searched job categories for Fda Contractor jobs in California are:

Fda Contractor jobs near you
Infographic showing various Fda Contractor job openings in California as of August 2026, with employment types broken down into 77% Full Time, 4% Part Time, 15% Contract, and 4% Nights. Highlights an 94% In-person, and 6% Remote job distribution.

FDA Laboratory Assistant full time Irvine, CA

Infinisource Consulting Solutions

Irvine, CA • On-site

Full-time

Medical, Dental, Vision, Life, Retirement

Posted 19 days ago

Job description

Job Type
Full-time
Description
INFINISOURCE CONSULTING SOLUTIONS (ICS)
InfiniSource Consulting Solutions (ICS), a 150+ employee government contractor specializing in Management Consulting, Information Technology, and Professional Services to the federal government. We tailor our services to meet the specific needs of our civilian, defense, and private-industry sponsor. Our corporate support processes are ISO 9001 certified, giving our customers the confidence that we are continually measuring and improving upon the support we provide and are committed to the highest level of customer satisfaction.
Position Title: Laboratory Assistant
Position Type: Full-Time
Work Schedule / Location:
  • Work hours shall be between 7:00 a.m. to 5:00 p.m., Eastern Time, Monday through Friday, excluding Federal holidays.

Salary: Commensurate with experience
Position Description:
  • The Laboratory Assistant support the Lab Tech on the Glassware and Media and Bulk Solution Preparation Support Services. The Laboratory Technician reports directly to the Laboratory Lead.
  • The key tasks will include media preparation, glassware decontamination, material management/dissemination of glassware, and medical waste management.
  • Laboratory support services will be operated in accordance with the current USP, EPA, OSHA, and FDA regulations.
  • Decontaminate glassware via sterilization that is designated as microbial contaminated. Any waste shall be discarded in accordance with medical/pathological waste (MPW) handling procedures as specified in regulations and SOPs.
  • Provide and distribute MPW approved receptacles including sharps containers, burn boxes, broken glass containers, autoclave bags, red bags, and liquid waste receptacles to the laboratories and designated MPW collection points.
  • On a daily basis, collect and remove MPW from the laboratories and designated collection points and transport to the facility's designated autoclave areas in leak-proof, secondary containment.
  • Maintain the Government laboratory generated MPW form documenting the waste stream for each receptacle.
  • Maintain sufficient materials for packaging MPW in the designated autoclave rooms and cold storage areas.
  • Segregate used reagent bottles from other MPW and store for de-barcoding by Government.
  • Segregate any hazardous, non-MPW from MPW and store for disposal by Government.
  • Autoclave MPW per approved Contractor SOPs and depending on waste stream, either store in the facility's designated cold storage area or dispose of per the sanitary sewer (i.e., sink disposal) per approved SOPs.
  • Receive and process requests for media and bulk solutions.
  • Prepare and deliver fresh standard and customized media from dehydrated and chemically defined bacteriological culture media, tissue culture media, basic media formula, and customized chemical solutions in bulk (liter) container, tube, slant, and Petri dish forms.
  • Schedule and coordinate annual preventative maintenance required for media prep equipment including the media jet(s) and media clave(s).
  • Shall perform all necessary housekeeping duties in order to keep clean and orderly storerooms/media preparation areas and/or as required to comply with Good Laboratory Practices regulations.
  • Other duties as assigned.

Requirements
  • Must have H.S. Degree with science lab experience
  • Prefer favorable Tier 2 Investigation (Public Trust). Must complete a favorable background investigation suitable for the issuance of a PIV card.

InfiniSource Consulting Solutions is committed to hiring and retaining a diverse workforce. We are proud to be an Equal Opportunity/Affirmative Action Employer, making decisions without regard to race, color, religion, creed, sex, sexual orientation, gender identity, marital status, national origin, age, veteran status, disability, or any other protected class US Citizenship is required for most positions.
ICS offers a competitive salary and a generous benefits package. This package includes medical, dental, vision, life, short and long-term disability insurances, and a 401(k)-retirement plan.

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