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Fda Project Jobs in Virginia (NOW HIRING)

Cadence Inc

Validation Engineer II

Staunton, VA · On-site

$83K - $105K/yr

... across multiple projects at our facility. This role is critical in ensuring compliance with regulatory standards (FDA, ISO 13485, 21 CFR Part 820), working closely with engineering, QA, and ...

Intellectt INC

Quarantine Specialist

Manassas, VA · On-site

Ensure operations comply with SQF, HACCP, FQP, FDA, and cGMP standards. Verify that dietary ... Support special quality projects as assigned. Participate in all required training programs.

Green Key Resources

Site Director

Charlottesville, VA · On-site

Ensuring adherence to standard operating procedures, good clinical practice (GCP), FDA regulations ... Must possess strong organizational, time management, problem solving, and project management skills ...

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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.
What are popular job titles related to Fda Project jobs in Virginia? For Fda Project jobs in Virginia, the most frequently searched job titles are:
What job categories do people searching Fda Project jobs in Virginia look for? The top searched job categories for Fda Project jobs in Virginia are:
What cities in Virginia are hiring for Fda Project jobs? Cities in Virginia with the most Fda Project job openings:
Fda Project jobs near you
Donor Services Trainer (Danville)

Donor Services Trainer (Danville)

The Blood Connection

Danville, VA • On-site

Full-time

Posted 20 days ago

The Blood Connection rating

4.3

Company rating: 4.3 out of 10

Based on 24 frontline employees who took The Breakroom Quiz

Job description

At The Blood Connection, every role plays a part in saving lives. Join our team and help make an impact in your community today!
Position Overview
A Donor Services Trainer provides and documents training for apheresis, special donations and when required, whole blood collections procedures. Training is performed in accordance to departmental procedures, processes, policies along with FDA and AABB regulations/standards and training records are maintained in a method that ensures completeness and accuracy. This role conducts departmental audits to ensure staff are performing tasks correctly and promptly takes action to correct any unapproved deviations. This role assists Donor Services management with various departmental tasks and projects. The Donor Services Trainer sets an exceptional example for excellent customer service and technical performance. This role provides on floor collection staff duties when required. This role travels to various fixed site centers as needed which may require short term out of town stays depending on distance and length of training needs.
Essential Functions
  • Provides training and development for staff performing donor collections
  • Obtains and maintains CPR instructor certification and provides CPR training for new hire and existing staff
  • Provides remedial training as indicated by Donor Services management
  • Provides updates in regard to trainee progress/challenges to appropriate manager
  • Ensures staff training manuals are inspection/audit ready
  • Updates departmental JDTRs (Job Description Training Requirements) as needed
  • Assists with training related issues during external and internal inspections/audits
  • Ensures Donor Services procedures, processes and policies are current and in compliance with regulatory standards
  • Performs departmental audits to ensure all equipment QC meets compliance standards
  • Assists with investigation and completion of Donor Services occurrence reports and provides retraining for staff with unacceptable occurrence rates
  • Assists with daily collection QC review when required
  • Works on floor performing collection duties when required
  • Performs special projects as indicated by Donor Services management
  • Provides back up for department management
  • Other duties as assigned or required

Departmental:
  • Maintains standards established by FDA, AABB, CLIA and other governing bodies; stays abreast of new and/or impending regulatory changes
  • Stays abreast of new trends, technology, regulations as related to donor collections
  • Acts as a resource for collections staff
  • Functions to foster teamwork and enhance operational success

Minimum Qualifications
  • High School Diploma or GED
  • CPR Instructor's Certification (preferred prior to hire, but may obtain after acquiring position)
  • Two years of blood collection experience
  • General knowledge of Hematology
  • Valid Driver's License with no major infractions and dependable transportation
  • Ability to organize and prioritize workload and meet deadlines
  • Excellent analytical, organizational, interpersonal, verbal, and written communications skills
  • Strong computer skills including intermediate skill level with Microsoft Word, Excel, and PowerPoint
  • Excellent customer services skills
  • Ability to read, understand, and follow written and verbal instructions
  • Ability to follow SOP in a heavily FDA regulated environment
  • Ability to communicate effectively, tactfully, and courteously to patrons, donors, sponsors, and co-workers
  • Ability to work with all levels and in a diverse work environment
  • Ability to establish and maintain effective working relationships with staff, management, and peers

Physical Demands
The physical demands described here are representative of those that must be met to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • Lifting and/or pulling/pushing up to 50 pounds
  • Standing or walking for an extended period
  • Bending and twisting

Equal Opportunity Employer Veterans/Disabled

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