(Contract) Manufacturing Investigations Specialist

Join a high-impact MSAT team where you will own the full deviation lifecycle, lead technical investigations, and partner with Manufacturing and Quality to resolve complex GMP events.

Job Title: (Contract) Manufacturing Investigations Specialist, MSAT

Location: Stafford, TX

Rate: $50-55/hr. (negotiable)

Contract Length: 6-9 months

Roles And Responsibilities

• Own and manage deviations from initiation through closure within the electronic Quality Management System (Veeva)
• Lead end-to-end deviation lifecycle activities including:
• Deviation triage, initiation, and scoping
• Technical impact assessment
• Root cause analysis (RCA)
• CAPA development and effectiveness verification
• Draft clear, concise, and technically sound investigation reports aligned with cGMP requirements
• Facilitate cross-functional investigation meetings and ensure alignment on root cause and corrective actions
• Apply structured problem-solving and risk assessment methodologies (e.g., DMAIC, FMEA, 5-Whys, Fishbone)
• Support timely closure of deviations and reduce backlog through structured workflow ownership
• Ensure investigations demonstrate strong technical rigor and regulatory defensibility
• Identify trends and recurring issues to support continuous improvement initiatives
• Partner with QA and Manufacturing leadership to reinforce quality culture and deviation best practices
  

REQUIRED QUALIFICATIONS (Education, Experience, Knowledge, Skills)

• Bachelor’s degree in Engineering, Life Sciences, or related technical field.
• 7 years of relevant experience in biotech or pharmaceutical manufacturing
• Direct experience owning and writing deviations and CAPAs in a cGMP environment
• Strong technical writing and documentation skills
• Experience with structured root cause analysis methodologies (DMAIC, FMEA, 5-Whys, Fishbone, etc.)
• Familiarity with electronic Quality Management Systems (EQMS), preferably Veeva
• Demonstrated ability to lead cross-functional technical discussions
  
  

Preferred Qualifications

• Experience in autologous cell therapy manufacturing
• Background in MSAT, Process Engineering, Technical Services, Manufacturing, or Quality Assurance
• Experience supporting pivotal and/or commercial-stage manufacturing operations
• Understanding of risk-based decision making in a regulated GMP environment
• Experience managing high-volume deviation environments
  
  

What happens next:

• Once you apply, you’ll proceed to next steps if your skills and experience look like a good fit. But don’t worry – even if this position doesn’t work out, you’re still in our network. That means our team of expert Science & Clinical recruiters will have access to your profile, making your opportunities limitless.
  
  

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

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