Senior QC Sample Management Lead

Job Description

Job Description

Description

A biopharmaceutical organization in the Raleigh, NC area is seeking a 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

This is a Contract to Hire position based out of Raleigh, NC.

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)

This is a fully onsite position in Raleigh,NC.

This position is anticipated to close on May 29, 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 View email address on ziprecruiter.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.