Client: Mid-sized biotech company developing novel biologics.
Industry: Biotechnology / Life Sciences
Positions: 2 QA Specialists and 3 Validation Engineers

Background

A biotech company was advancing a promising therapeutic candidate through clinical studies toward commercialization. To meet FDA submission timelines, validation of their GMP manufacturing and QC lab equipment and systems had to be completed within six months.

Their in-house Quality Assurance (QA) team was small, and several critical QA positions were vacant. Without additional resources, validation milestones would be missed — threatening both regulatory submissions and the company’s launch schedule.

Challenge

  • Vacant Roles: 2 QA Specialists and 3 Validation Engineers needed urgently.
  • Impact: Risk of delayed GMP and QC lab validation processes, leading to slower regulatory submissions.
  • Constraints: The client required multi-skilled professionals:
    • Validation Engineers had to support both laboratory and manufacturing systems.
    • QA Specialists needed strong validation expertise in addition to compliance knowledge.
  • Traditional staffing vendors struggled to source candidates with this breadth of expertise in the required timeframe

Solution by Assurea Staffing

Curated Network: Leveraged Assurea’s vetted pool of life sciences professionals with dual expertise across lab and manufacturing systems.

Role-Specific Screening: Candidates underwent scenario-based interviews, technical validation exercises, and compliance-focused assessments to ensure adaptability across roles.

Rapid Placement: Within 3 weeks, all five positions were filled with contract professionals who could integrate quickly into ongoing projects.

Onboarding Support: Assurea coordinated onboarding and alignment with internal SOPs, accelerating productivity from day one.

    Results

    Time-to-Fill: All positions were filled within 3 weeks, compared to the industry average of 10–12 weeks.


    Project Continuity: Validation and QA processes remained on schedule, allowing the biotech to meet its regulatory submission timeline.


    Client Satisfaction: The client praised the professionalism and expertise of the Assurea-placed staff, noting improved operational efficiency and reduced stress on their permanent team.

    Key Takeaways

    • A pre-vetted talent pool with specialized skills can drastically reduce time-to-hire.
    • Role-specific evaluation ensures candidates meet both technical and regulatory requirements.
    • Flexible staffing solutions allow biotech companies to maintain project timelines without compromising quality.