GMP Investigation Associate

Duke Careers

. Enable compliance of the Carolinas Cord Blood Bank with FDA regulations and FACT accreditation standards .

Posted 10/13/2026full-timeDurham • North Carolina • United StatesMid-Level💰 $67,919 - $102,898 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in ensuring compliance with FDA regulations and FACT accreditation standards, with a strong focus on quality assurance processes in the bioprocess development and cellular therapy manufacturing sectors.

Highest-signal resume keywords

Quality Assurance ExperienceGMP ComplianceCell Culture and Bioreactor OperationFDA Inspection ParticipationSOP Development and Review

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Bioprocess DevelopmentGMP Product ManufacturingDeviation ManagementCAPA ImplementationBatch Record ReviewInternal AuditingRegulatory ComplianceProcess Transfer to cGMP FacilitiesQuality Systems CollaborationAdverse Event Investigation

Soft Skills

Excellent Communication SkillsAttention to DetailOrganizational SkillsInterpersonal SkillsAnalytical Skills

Industry Keywords

Cellular TherapiesTissue-Based TherapiesClinical TrialsFDA RegulationsFACT AccreditationQuality ControlSOPsTraining PlansInternal AuditsRegulatory Inspections

About the role

Key responsibilities & impact

Enable compliance of the Carolinas Cord Blood Bank with FDA regulations and FACT accreditation standards
Initiate and complete deviations, investigations, CAPAs, memos to file, complaints, and adverse events related to GMP cellular product collection, manufacturing, review, and distribution
Collaborate with the Quality Systems Unit and collection, manufacturing, and review teams to investigate errors and identify corrective and preventative actions
Develop and edit SOPs related to GMP product manufacturing to ensure regulatory compliance
Review and correct batch records
Assist with FACT accreditation, including gap analysis against standards and identifying areas for improvement
Educate staff on policies, procedures, FACT standards, manuals, SOPs, training, and quality plans
Assist with FDA, FACT, and other agency inspections and help respond to observations
Prepare sites and manufacturing facilities for inspections and internal audits
Conduct periodic internal audits focused on equipment maintenance, safety procedures, training records, and SOP compliance
Liaise between the Carolinas Cord Blood Bank and Quality Systems Unit to schedule audits and coordinate responses to findings

Requirements

What you’ll need

Bachelor's degree in a biological science
Six years of experience in quality assurance or quality control related to clinical trials
A master's degree in a related field may substitute for 2 years of required experience
Equivalent combination of relevant education and/or experience
Relevant knowledge and industrial experience in bioprocess development for manufacture of cellular and tissue-based therapies
Experience transferring processes to cGMP facilities for clinical or commercial manufacture
High level of skill and experience with cell culture and bioreactor operation and scale-up, or quality assurance experience for these processes
Preferred experience taking a product from process development to clinical trials and, if applicable, through commercial FDA licensure
Preferred experience participating in FDA inspections and other regulatory, accreditation, and sponsor audits
Excellent written and oral communication skills
Attention to detail
Excellent organizational, interpersonal, and analytical skills
Good judgment and strong operational focus
Self-directed team-player ability

Benefits

Comp & perks

Health insurance plans
Generous paid time off
Retirement programs with employer contributions
Tuition assistance for employees and their children
Comprehensive medical and dental care programs
Generous retirement benefits
Family-friendly and cultural programs