Senior Specialist, Quality Engineer

We are seeking a dedicated Senior Specialist, Quality Engineer to lead quality oversight for GCP inspection readiness. The role involves ensuring system readiness through documentation review, contributing to program development and calibration, ensuring compliance with data integrity, and maintaining inspection-ready documentation through collaboration. The Quality Manager will support cross-functional teams to ensure compliant startup execution.

Key

Responsibilities:

Technical

• Lead Quality oversight for GMP readiness and facility startup activities.
• Review/approve qualification and validation deliverables for equipment, utilities, facilities, and DS processes.
• Verify system readiness through documentation review (drawings, P&IDs, turnover packages).
• Contribute to PM and calibration program development, including criticality assessments.
• Lead or execute change controls, risk assessments (e.g., FMEA), and troubleshooting.
• Ensure compliance with data integrity, Part 11, and ALCOA++ principles.
• Maintain inspection‑ready documentation and asset status through collaboration with Engineering, Validation, and Maintenance.
• Support cross‑functional teams to ensure compliant startup execution.

Non‑Technical

• Results-oriented, accountable, and able to operate in ambiguity.
• Strong organization, communication, and relationship-building skills.
• Adaptable to change with a growth mindset.
• Promotes inclusion, teamwork, innovation, and enterprise-wide thinking.
• Resourceful, proactive, and committed to continuous improvement.

Work Environment

• This role is within a leading global specialty pharmaceutical and biotechnology company based in Tokyo, Japan.
• As part of expanding its global footprint, the company is constructing its first U.S. manufacturing site in North Carolina, with an investment exceeding half a billion dollars. This facility will operate as a dedicated biologics manufacturing center, support high-skilled job creation, and strengthen the company's worldwide production network.

This is a Contract position based out of Sanford, NC.

The pay range for this position is $55.00 - $65.00/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 Sanford,NC.

This position is anticipated to close on Feb 20, 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 due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.