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Fda Project Jobs in Nevada (NOW HIRING)

QA Tech

Henderson, NV · On-site

$25/hr

Monitors plant compliance with HACCP, PMO, WDI QFSE and SQF guidelines and policies. In conjunction ... HACCP, SQF and (FDA & USDA21CFR & 7 CFR or even 9 CFR) - a plus. * Demonstrated QA or production ...

Support company policies, procedures, FDA regulations and good manufacturing practices. * Handle customer complaints and failure reports. * Plan and execute production improvement projects from ...

Quality Engineer

Reno, NV · On-site

$75K - $85K/yr

Effectively engage in project as the Quality Engineering resource. * Formulates or assists in ... FDA 21 CFR 820. * Auditing education and experience. * Ability to work effectively with various ...

Assembler

Reno, NV · On-site

$16 - $19.75/hr

... projects * Adhere to general safety rules, manufacturing procedures, company policies and procedures, QSR, and FDA Regulations. * Identify and report any product quality problems * Facilitate ...

Quality Engineer

Reno, NV · On-site

$71K - $92K/yr

Effectively engage in project as the Quality Engineering resource. * Formulates or assists in ... FDA 21 CFR 820. * Auditing education and experience. * Ability to work effectively with various ...

Senior Manufacturing Engineer

Reno, NV · On-site

$110K - $150K/yr

... FDA regulations, and good manufacturing practices. * Handle customer complaints and failure reports. * Responsible for planning and executing production improvement projects from concept to ...

All other Duties and projects assigned Qualifications: * Must comply with GMP requirements ... We are a drug free workplace, regulated by the FDA, required to follow Federal Guidelines ...

Showing results 41-60

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 are the key skills and qualifications needed to thrive as an FDA project manager?

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.

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 qualifications do you need to work for the FDA?

To work as an FDA project professional, candidates typically need a bachelor's degree in a relevant field such as biology, chemistry, or health sciences. Advanced positions may require a master's degree or higher, along with relevant experience, knowledge of regulatory guidelines, and strong analytical skills. Certifications like Regulatory Affairs Certification (RAC) can also enhance qualifications.

What cities in Nevada are hiring for Fda Project jobs?

Cities in Nevada with the most Fda Project job openings:

$25/hr

Full-time

Medical, PTO

Posted 27 days ago


Wells Enterprises rating

7.3

Company rating: 7.3 out of 10

Based on 20 frontline employees who took The Breakroom Quiz

177th of 440 rated food and drinks producers


Job description

Company: Wells Enterprises (a Ferrero Company)

Functional Area: Manufacturing

The Role

This position is located in Henderson, NV. Under the direction of the Quality Assurance Supervision / Management, conducts assessments of the production process and production facility against established food safety and food quality standards. This individual is the primary responsible for: sample collection; record review; SPC; coaching and partnering with production staff in investigating, documenting and resolving process upsets, microbiology OOS instances. Drives at the line level appropriate application of food safety and food quality programs and practices and if issues arise taking appropriate actions in light of the data presented. The incumbent works in conjunction with QA Management / Supervision; Process Operator; Production. 

What You'll Do

  • Under the direction of QA Supervision / Management, assures company food safety and food quality programs are appropriately applied during production, maintenance and CI events. Participates in line operations through attendance at Line Meetings and the sharing of key quality information such as environmental and micro data, hold statistics / first-time quality data, GMP coaching.
  • Reviews processing, manufacturing, maintenance, and sanitation records as required to promote food safety and food quality initiatives and practices such as finished product and ingredient positive release. If shortcomings are encountered, helps drive situation to an appropriate solution. Reviews manufacturing control documentation, including, but not necessarily limited to: metal detection; code check; ingredient trace ability and assures discrepancies or deficiencies are properly addressed.
  • Collects product, in-process, ingredient, and environmental samples as necessary and assists in investigations as required. Performs some instrumental and wet-chemistry analyses on ice-cream samples as required to verify and validate adequacy of cleaning programs and mix-formulation compliance to company standards. Using statistical tolls as necessary, assists processing laboratory in maintaining an analytical control program for tests done in-process and appropriate analytical controls over tests done in QA lab.
  • In conjunction with Quality Coordinator, assures only the most current SOPs, Standard Work, Standard Settings and other manufacturing control documents are in place and maintained. Executes requirements of the QMS (Quality Monitoring Scheme).
  • Monitors plant compliance with HACCP, PMO, WDI QFSE and SQF guidelines and policies. In conjunction with Quality Coordinator, by conducting or participating in plant inspections as well as investigation of product and environmental out-of-limits situations, documents these investigations and implements sustainable corrective actions as required. Fosters a positive food safety and food quality culture amongst peers across plant disciplines and promotes compliance with established quality programs and practices.

Starting Pay Rate: $25.00

Shift/Hours: Days.

Wells Enterprises, a Ferrero company, is one of the largest ice cream manufacturers in the United States and the maker of well-loved brands including Blue BunnyHalo TopBomb Pop, and Blue Ribbon Classics and today Trolli, Butterfinger 100grandBaby RuthNutella and Kinder Bueno

Wells Enterprises is a 2 billion company employing 4,000 employees, across 4 production plants and 2 main hub locations, Chicago and Le Mars. Guided by innovation, quality, and a people-first mindset, Wells is committed to delighting consumers and developing exceptional teams.

As part of the Ferrero Group, Wells combines its strong U.S. heritage with Ferrero's global standards of excellence, offering a unique opportunity to grow within a dynamic, values-driven, and international environment.

At Wells, our people-and their experience-sit at the heart of our ambition.  Learn more at www.wellsenterprisesinc.com.

What We Offer

At Wells, we're proud to support our employees with comprehensive benefits that enhance health, financial wellness, and include paid time off (PTO). Eligible employees may also receive an annual incentive bonus based on Company performance.  Learn more about our benefits here. 

What You'll Bring

  • Associate or Bachelor's degree in Science, Microbiology, and / or Food Science a minimum (Which may be substituted for with demonstrated experience with food or nutritional products sanitation and cleaning or manufacturing and/ or quality programs required). Familiarity with food / nutritional product legislation. HACCP, SQF and (FDA & USDA21CFR & 7 CFR or even 9 CFR) - a plus.
  • Demonstrated QA or production / technical experience in a in a medical product, food or nutritional product manufacturing or analytical laboratory setting; previous experience in an FDA / USDA regulated industry.
  • Demonstrated experience with Cleaning, Sanitation and Chemical Control practices and an understanding of dairy / food manufacturing equipment design. 
  • Familiarity with microbial flora and fauna found in food (dairy) plants and monitoring and control programs associated with these.
  • Familiarity with manufacturing, quality and chemical sanitation principles, specifically food or nutritional products. General ability to understand facility specific processes such as weighing, measuring, mixing, cleaning, sterilization, documentation, process control automation.
  • Ability to promote the requirements of the plant QMS and other QA programs such as GMPs, good documentation practices; SPC.
  • If you meet these requirements and are interested in this position, to be considered for an interview you must complete an online application at www.wellscareers.com
  • Wells Enterprises is an EEO/AA employer M/F/Vet/Dis

What You'll Bring

  • Associate or Bachelor's degree in Science, Microbiology, and / or Food Science a minimum (Which may be substituted for with demonstrated experience with food or nutritional products sanitation and cleaning or manufacturing and/ or quality programs required). Familiarity with food / nutritional product legislation. HACCP, SQF and (FDA & USDA21CFR & 7 CFR or even 9 CFR) - a plus.
  • Demonstrated QA or production / technical experience in a in a medical product, food or nutritional product manufacturing or analytical laboratory setting; previous experience in an FDA / USDA regulated industry.
  • Demonstrated experience with Cleaning, Sanitation and Chemical Control practices and an understanding of dairy / food manufacturing equipment design. 
  • Familiarity with microbial flora and fauna found in food (dairy) plants and monitoring and control programs associated with these.
  • Familiarity with manufacturing, quality and chemical sanitation principles, specifically food or nutritional products. General ability to understand facility specific processes such as weighing, measuring, mixing, cleaning, sterilization, documentation, process control automation.
  • Ability to promote the requirements of the plant QMS and other QA programs such as GMPs, good documentation practices; SPC.

If you meet these requirements and are interested in this position, to be considered for an interview you must complete an online application at www.wellscareers.com

Wells Enterprises is an EEO/AA employer M/F/Vet/Dis


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