Analytical Lab Specialist (Contract)

Location: Morrisville, NC
Schedule: M-F day shift 

Our client is a biotechnology company with a mission to unlock new opportunities for viral gene therapy through genomics-driven discovery. They focus on delivering life-changing advances for individuals with genetic disorder and they are looking for a highly motivated Analytical Laboratory Specialist to join their team!

Key Responsibilities

• Coordinate and manage external laboratory testing activities, including raw material testing and related analytical work

• Serve as primary point of contact between internal teams and contract testing labs

• Track sample submissions, testing timelines, deliverables, and final results

• Review analytical testing results for accuracy, completeness, and GMP compliance

• Summarize and communicate findings to internal stakeholders

• Identify data trends or potential issues and escalate when necessary

• Support internal analytical data and record reviews as needed

• Ensure external testing documentation aligns with GMP and internal standards

• Assist with analytical record and report review

• Support deviation investigations and documentation

• Contribute to method documentation, implementation, and transfer activities

• Partner closely with Analytical Sciences, Quality Control, Supply Chain, and Process Sciences teams

• Provide support across multiple testing projects as priorities shift

Qualifications

• Bachelor’s degree in Analytical Chemistry, Chemistry, Biochemistry, or related field

• Minimum 5 years of experience in Analytical Sciences, Quality Control, or a GMP-regulated environment

• Strong understanding of analytical testing workflows and data review practices

• Experience managing or working with contract testing laboratories

• Solid knowledge of GMP requirements and documentation standards
  
  ***This job description is a complete list of all desired skills but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!***
  
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