Description
A biopharmaceutical organization in the Raleigh, NC area is seeking a Senior QC Sample Management Lead to design, implement, and oversee the end-to-end sample lifecycle within a GMP Quality Control environment.
This individual will play a critical role in building and standardizing sample management processes from the ground up, ensuring efficient, compliant, and inspection-ready handling of samples across QC Chemistry and Microbiology operations.
The ideal candidate brings a combination of hands-on QC sample management experience and process/system development expertise, with the ability to drive cross-functional alignment and scalable workflows.
Key Responsibilities:
Sample Lifecycle Process Development
Design and implement standardized workflows for the full QC sample lifecycle, including receipt, accessioning, triage, testing coordination, storage, retention, and disposal
Establish clear frameworks for sample prioritization across release, stability, environmental monitoring (EM), and investigation samples
Define and maintain chain-of-custody processes ensuring full traceability and data integrity
Systems & LIMS Optimization
Lead the configuration, optimization, or enhancement of LIMS and sample tracking systems
Develop workflows for sample login, status tracking, and reporting within electronic systems
Partner with IT and QC stakeholders to ensure systems support operational efficiency and compliance
SOPs, Compliance & Inspection Readiness
Author, review, and maintain SOPs, work instructions, and training materials related to sample management
Ensure alignment with cGMP, GLP/GDP, and ALCOA+ data integrity principles
Establish inspection-ready documentation practices and support audit/inspection activities
Sample Flow & Operational Strategy
Develop and implement sample flow management processes to support QC Chemistry and Microbiology testing timelines
Identify risks to turnaround time and proactively implement mitigation strategies
Partner with QC leadership to align sample throughput with laboratory capacity
Metrics, Reporting & Continuous Improvement
Establish and track KPIs including:
Turnaround time (TAT)
On-time-in-full (OTIF) performance
Sample backlog and aging trends
Build and maintain dashboards to provide visibility into QC sample performance
Lead continuous improvement initiatives to enhance efficiency, throughput, and compliance
Cross-Functional Collaboration
Serve as the central point of coordination for sample-related activities across QC, Manufacturing, Warehouse, and QA
Develop communication and escalation frameworks to ensure alignment across stakeholders
Support onboarding and training of QC personnel on sample handling processes and systems
Quality Systems Ownership
Lead or support deviations, CAPAs, and change controls related to sample management processes
Identify recurring issues and drive sustainable corrective actions and process improvements
Required Qualifications
Associate's degree in a scientific discipline (Bachelor's preferred)
5+ years of experience in GMP pharmaceutical, biotechnology, or medical device environments
Strong experience in QC sample management, sample logistics, or LIMS-based sample tracking
Demonstrated experience developing or improving processes, workflows, or systems within QC operations
Solid understanding of:
cGMP and GDP requirements
Data integrity (ALCOA+) principles
QC Chemistry and Microbiology sample types and workflows
Experience working in regulated environments with strict documentation and audit requirements
Skills
GMP, QC Sample Management, stability program, environmental monitoring
Top Skills Details
GMP,QC Sample Management,stability program,environmental monitoring
Additional Skills & Qualifications
Preferred Qualifications
Experience supporting stability programs and environmental monitoring (EM) logistics
Hands-on experience with LIMS implementation, configuration, or optimization
Experience in greenfield, startup, or rapidly scaling manufacturing/QC environments
Prior involvement in SOP authorship, training program development, and cross-functional initiatives
Strong analytical skills with experience managing performance metrics and dashboards
Experience Level
Expert Level
Job Type & Location
This is a Contract to Hire position based out of Raleigh, NC.
Pay and Benefits
The pay range for this position is $40.00 - $60.00/hr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: - Medical, dental & vision - Critical Illness, Accident, and Hospital - 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available - Life Insurance (Voluntary Life & AD&D for the employee and dependents) - Short and long-term disability - Health Spending Account (HSA) - Transportation benefits - Employee Assistance Program - Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a fully onsite position in Raleigh,NC.
Application Deadline
This position is anticipated to close on May 22, 2026.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.
Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.