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Fda Project Jobs (NOW HIRING)

QSE7

Be Seen First

Sr. Project Manager

Philadelphia, PA · Remote

$80 - $120/hr

The ideal candidate will serve as a project manager, strategic thought leader and hands-on project lead, driving complex FDA regulatory programs from initiation through resolution. You will own ...

Hitachi, Ltd.

FDA Validation Engineer

Nashville, TN · On-site

Write overall project quality (validation scope) plans and validation summary reports. * Organize, guide, and write requirement specifications. * Oversee, execute and review qualification ...

Stereotaxis

Project Manager

Minneapolis, MN

Ensure all projects comply with FDA, ISO 13485, and other relevant medical device industry regulations and standards. Identify potential project risks and develop mitigation strategies. Conduct ...

Hitachi

FDA Validation Engineer

Nashville, TN

Write overall project quality (validation scope) plans and validation summary reports. * Organize, guide, and write requirement specifications. * Oversee, execute and review qualification ...

Inherent Technologies

Project Engineer

Danvers, MA · On-site

Experience supporting FDA regulated products * Project Management Professional (PMP) Certification * Experience working with Agile development with a Continuous Discovery/Delivery mindset

Kaav Inc

SAP Project Manager-CA

La Verne, CA · On-site

The ideal candidate will have extensive experience in SAP S/4HANA upgrade projects , preferably in regulated industries like pharma , ensuring compliance with GxP, FDA, and other regulatory standards

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Fda Project information

What is an FDA Project?

An FDA Project typically refers to a project that involves compliance with the U.S. Food and Drug Administration (FDA) regulations. These projects can include developing, testing, or bringing to market medical products such as drugs, medical devices, biologics, or food items. The goal of an FDA Project is to ensure that products meet safety, efficacy, and quality standards set by the FDA before they are approved for public use. Such projects often require extensive documentation, clinical trials, and regulatory submissions to obtain FDA approval.

What is the difference between Fda Project vs Fda Reviewer?

AspectFda ProjectFda Reviewer
Required CredentialsTypically requires a background in life sciences, engineering, or related fields; often includes project management certificationsRequires a degree in life sciences, pharmacy, or medicine; often needs FDA-specific training or experience
Work EnvironmentProject teams within pharmaceutical or biotech companies, regulatory agencies, or consulting firmsRegulatory agencies, pharmaceutical companies, or biotech firms reviewing submissions
Employer & Industry UsageUsed in project management contexts to oversee regulatory submissions and complianceUsed in regulatory review processes to evaluate drug, device, or food applications

In summary, Fda Project roles focus on managing regulatory initiatives and ensuring compliance within organizations, while Fda Reviewers are responsible for evaluating and approving submissions directly for regulatory approval.

What are the key skills and qualifications needed to thrive as an FDA Project Manager, and why are they important?

To thrive as an FDA Project Manager, you need a strong background in regulatory affairs, project management, and a degree in life sciences or a related field. Familiarity with FDA submission requirements, electronic common technical document (eCTD) systems, and project management tools like MS Project or Asana is essential. Excellent communication, organization, and problem-solving abilities help manage cross-functional teams and ensure compliance. These skills ensure that projects meet regulatory standards, progress efficiently, and achieve timely FDA approvals.

What are some common challenges faced by professionals working on FDA project teams?

Professionals working on FDA project teams often encounter challenges related to regulatory compliance and shifting guidelines. Navigating complex documentation requirements, coordinating with cross-functional teams (such as clinical, regulatory, and quality assurance), and meeting strict submission deadlines are all common hurdles. Effective communication and adaptability are essential, as projects frequently involve collaboration across departments and ongoing updates based on regulatory feedback. Successfully managing these challenges helps ensure product approval and supports career advancement within regulatory affairs.
More about Fda Project jobs
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What states have the most Fda Project jobs? States with the most job openings for Fda Project jobs include:
What job categories do people searching Fda Project jobs look for? The top searched job categories for Fda Project jobs are:
Fda Project jobs near you
Infographic showing various Fda Project job openings in the United States as of July 2026, with employment types broken down into 87% Full Time, 10% Part Time, 2% Contract, and 1% Nights. Highlights an 91% Physical, 1% Hybrid, and 8% Remote job distribution.
QA Supervisor | Nights | KanPak | Penn Yan, NY

QA Supervisor | Nights | KanPak | Penn Yan, NY

Golden State Foods

Penn Yan, NY • On-site

$71K - $75K/yr

Full-time

Medical, Dental, Vision, Retirement, PTO

This job post has expired today. Applications are no longer accepted.

Golden State Foods rating

6.3

Company rating: 6.3 out of 10

Based on 15 frontline employees who took The Breakroom Quiz

281st of 395 rated food and drinks producers

Job description

Description
KanPak®, a Golden State Foods company, is a global leader in the development and manufacturing of beverage, yogurt, and dessert solutions. Aseptic technology is core to many of our products, allowing them to ship and store without refrigeration for up to 12 months.
From coffee beverages and creamers to yogurt, frozen desserts, and specialty beverages, KanPak delivers innovative solutions supported by state-of-the-art manufacturing and exceptional customer service.
QUALITY ASSURANCE SUPERVISOR
About the Role
Golden State Foods is seeking a Quality Assurance Supervisor for our Penn Yan, NY manufacturing facility. In this role, you will lead Quality Technicians and Leads while ensuring all products meet strict food safety, regulatory, and customer standards. You'll oversee laboratory operations, documentation accuracy, calibration programs, and inspection readiness in a fast-paced, aseptic production environment. This position plays a key role in maintaining compliance with USDA tracking, internal audits, and customer quality programs.
What You'll Do
  • Supervise, schedule, and lead up to 30 Quality Technicians and Leads
  • Ensure proper operation of lab equipment, including calibration, maintenance, and troubleshooting
  • Manage lab supply inventory and maintain equipment readiness
  • Oversee quality, food safety, and regulatory program compliance and documentation
  • Review QC records (product checks, labeling, packaging inspections, microbial tests, antibiotic testing, temperature checks, bulk receiving tests)
  • Maintain calibration programs and master logs
  • Manage documentation accuracy, reporting, and record retention
  • Coordinate sampling and reporting with the NY Department of Agriculture
  • Support USDA tracking and compliance programs
  • Collect, verify, and analyze microbiological and analytical data
  • Develop and improve quality programs to meet customer and audit requirements
  • Participate in internal audits and represent QA during all audits (internal, external, customer)
  • Ensure readiness for FDA, PMO, USDA, and customer inspections
  • Train, coach, and lead Quality Technicians and Leads
  • Communicate food safety and quality concerns to the Quality Systems Manager
  • Perform other duties as assigned
What You'll Need
Required
  • High school diploma or GED required
  • Flexibility to be on-call and work any shift as needed
  • Strong communication, leadership, and team management skills
  • Ability to work under pressure and meet deadlines
  • Strong computer skills (data entry, reporting, analysis)
  • Ability to handle confidential information
  • HACCP experience required (certification required or obtainable)
  • Better Process Control School certification (or ability to obtain)

Preferred
  • Knowledge of laboratory testing and data collection
  • Familiarity with FDA and PMO regulations
  • Strong understanding of GMPs and Good Documentation Practices
  • Degree in Food Science or related field preferred
  • 5+ years of quality control and manufacturing experience preferred
  • 2-3 years of leadership or supervisory experience preferred
The Schedule & Setting
  • Full-time, Hours- TBD to meet facility needs
  • Flexibility required for weekends, overtime, and schedule changes
  • Work environment includes laboratory, production, and processing areas
  • Physical requirements include standing, walking, bending, reaching, kneeling, and lifting up to 50 lbs
Pay & Benefits
Pay Range: $71,000 - $75,000 annually
Additional Compensation: Overtime and additional pay may apply
Benefits Include:
  • Medical, Dental, Vision, Disability insurance
  • Flexible Spending Accounts (FSA)
  • Employee Assistance Program (EAP)
  • Voluntary insurance options
  • 401(k) retirement plan
  • Paid Time Off (vacation, sick time, and company holidays)

EQUAL OPPORTUNITY EMPLOYER
KanPak, LLC encourages diversity in the workplace; we are an Equal Opportunity Employer. Minority/Female/Sexual Orientation/Gender Identity/Disability/Veteran
Applicants only; No Recruiters please.
KanPak, LLC is an equal opportunity employer and, as such, affirms to recruit, hire, train, and promote, in all job classifications, without regard to race, religion, color, national origin, sexual orientation, gender identity, citizenship, sex, age, veteran status, disability, genetic information, or any other protected characteristic.
KanPak will not discriminate against persons because of their disability, including disabled veterans, and will make reasonable accommodations for known physical or mental limitations of qualified employees and applicants with disabilities
WHY JOIN US
Golden State Foods (GSF) is one of the largest diversified suppliers in the food industry, manufacturing a range of products including sauces, dressings, condiments, syrups, and toppings for leading restaurant and retail brands.
Join GSF and grow your career with a global food industry leader who:
  • People First: At Golden State Foods, we're not just a company; we're a dynamic community where your talents are celebrated, and your ambitions are nurtured.
  • Values Driven: Our core values drive everything we do, creating a culture of innovation, integrity, and excellence. But we're not content with just being great; we strive for greatness in every aspect of our work.
  • People Development: At GSF we strive to continually develop our people to prepare us all for the needs of tomorrow.
  • Philanthropy & Sustainability: We're committed to making a difference beyond our walls through philanthropy and sustainability efforts across all our locations around the globe.
  • Extensive Benefits: Golden State Foods believes in a holistic approach to wellness focusing on the whole person with benefits that support those needs.
Equal Opportunity Employer:
We're proud to be an equal opportunity employer. Our company values diverse perspectives and is committed to creating an inclusive and respectful workplace where every person is supported and empowered to thrive.

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