Engagement Models Staff Augmentation

Need rapid, flexible access to top talent? Fill staffing gaps with an individual or team of qualified resources. Our large staff provides broad capability and specific expertise through a convenient staff augmentation model for contracted full-time engagements.

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A convenient, flexible solution to life science resourcing.

Extend your internal team with one or several skilled life science professionals. Our resources hit the ground running to immediately add value to your company through a contingent staff augmentation model.

We connect you to the skilled professionals you need to build, scale, and efficiently manage projects through a flexible contracted engagement that better reflects cyclical or project-based demand while infusing new skills and experiences into your team either on-site or remotely.

Tap into diverse competencies and skillsets for a predetermined or open-ended amount of time based on your evolving needs. With The FDA Group as your staff augmentation partner, you can easily increase or decrease your workforce as needs fluctuate—all while finding cost efficiencies in recruiting, screening, and onboarding staff.

All of our services are backed by a Total Quality Guarantee.

Scale your team as needs change.

Get rapid, flexible access to qualified consultants, contractors, and candidates in an increasingly competitive labor environment.

Fill in-house staffing gaps with perfect-fit talent.

We guarantee you’ll get the right resource, the first time.

Get world-class capability and expertise at a competitive rate.

Access our large, global staff of resources at a rate that fits your budget while avoiding extra payroll expenses.

FUNCTIONAL AREA Quality Assurance

Our quality and compliance specialists have extensive knowledge and experience in relevant regulations, guidance, and best practices related to quality system management throughout the regulated life science industries.

  • Fill in-house staffing gaps and scale your quality assurance function to meet changing demands.
  • Cost-effectively acquire the talent you need, where you need them.

We can fulfill contracted and direct hire resource placement needs in a variety of roles and functions including, but not limited to:

  • Global/Regional Director
  • Head of Department
  • Team Lead
  • Project Manager
  • Complaints Handler
  • Auditor
  • Technician
  • Quality Assurance Officer
  • Site Analyst
  • CAPA Specialist
  • Sterility Assurance Specialist
  • Quality Management System (QMS) Specialist

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Functional Area Regulatory Affairs

We can assist your organization's regulatory staffing needs from the associate all the way through the senior level, covering virtually any specific skill set or expertise required. Our regulatory staffing capabilities range from an individual associate-level resource to a seasoned regulatory consultant with extensive experience leading or assisting with regulatory filings.

Our contracted and direct hire regulatory resources can fulfill functional needs and augment your team—providing access to experienced regulatory professionals that see projects through to success on time and on budget. 

Our regulatory resources provide expertise and capability in functional requirements including, but not limited to:

  • Leading or supporting FDA and global regulatory filings and health authority engagement
  • Augmenting internal staff and/or outsourcing key regulatory functions in any capacity
  • Leading or supporting developmental or approved product filings through CMC experience and expertise
  • Providing comprehensive technical knowledge and guidance into labeling and promotional activities
  • Managing all regulatory documentation as part of the start-up, conduct, and close-out phases
  • Ensuring submissions comply with regulations
  • Managing submissions and document storage processes
  • Staying abreast of all regulations to ensure documentation compliance

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Functional Area Clinical Operations

Demand for talented clinical operations professionals grows each day. How do you find the resource you need when you need them? Through years of connecting clinical operations experts with opportunities around the world, we’ve developed a large active and extended pool of talented professionals.

  • Fill in-house staffing gaps and scale your clinical operations to meet changing demands
  • Cost-effectively acquire the talent you need, where you need them
  • Work towards accurate and timely completion of your clinical trials
  • Cut down on administration, better control your overhead, and reduce turnover

We can fulfill clinical contracted and direct hire resource placement needs in a variety of roles and functions including, but not limited to:

  • Clinical Operations
  • Clinical Project Management
  • Clinical Monitoring
  • Biometrics & Data Management
  • Medical Writing

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FUNCTIONAL AREA Commissioning, Qualification & Validation

Power your commissioning, qualification, and validation operations with experienced life science resources. Fill internal gaps or target a specific role with an individual resource or team to see your project or program through to success. We provide you with support no matter which role you need to fill or which phase your project is in.

  • Fill in-house staffing gaps and scale your quality assurance function to meet changing demands.
  • Cost-effectively acquire the talent you need, where you need them.

We can fulfill contracted and direct hire resource placement needs in a variety of functions including, but not limited to:

  • Validation Master Plans (VMPs)

  • Design Qualification (DQ)

  • Installation Qualification (IQ)

  • Operational Qualification (OQ)

  • Performance Qualification (PQ)

  • Equipment Validation

  • Software Validation

  • Process Validation

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FUNCTIONAL AREA Manufacturing & Engineering

Our network of manufacturing and engineering resources span across multiple disciplines to ensure your needs are met in whatever role you need to fill. Whether you’re implementing a global document control system or develop a package for your product we have the expertise to assist you with the staffing model that fits.

  • Fill in-house staffing gaps and scale your quality assurance function to meet changing demands.
  • Cost-effectively acquire the talent you need, where you need them.

We can fulfill contracted and direct hire resource placement needs in a variety of functions including, but not limited to:

  • Product & Personnel Controls

  • Aseptic Processing

  • Biologics Manufacturing

  • Product Assembly

  • Packaging & Labeling

  • Process Optimization

  • Sterilization

  • Lyophilization

  • Purification

  • Software Engineering
  • Product, Process, and Equipment Engineering

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Why work with The FDA Group?

 
  • Exclusive life science focus and expertise
  • Dedicated account management team
  • Right resource, first time (95% success)
  • 97% client satisfaction
  • Total Quality Guarantee

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Our Proven Process

Introductory Conversation

  • About Us
  • About You
  • Scope Of Work

Resources Definition

  • Background And Expertise
  • Location Of Resource
  • Rate Rightsizing

Proprietary Resource Selection Process

  • Recruiting Team External Search
  • In-House Subject Matter Experts
  • Resource Identification

Resource Presentation

  • CV And Rate
  • Perfect Match Summary
  • Interview Call Coordination

Agreement Processing

  • MSA And Addendums
  • Supplier Qualification
  • Kickoff Coordination

Account Management

  • Project Management Of Resource
  • Satisfaction Management For Client
  • Total Quality Guarantee

Contact us and get the conversation started.

Our resources can be utilized to meet the wide range of requirements throughout the life sciences, as well as to support staffing assignments, lead and manage related activities, bridge staffing gaps, and provide long-term or interim leadership.


Please contact us to learn more about fulfilling specific resourcing needs. We help clients secure a wide variety of life science resources for both contracted and direct hire engagements with the perfect combination of qualifications, experience, and motivation for succeeding in challenging and demanding projects.