Method Transfer Documentation Specialist

The Method Transfer Documentation Specialist is responsible for supporting the organization, assessment, and remediation of legacy, paper-based Quality Control (QC) method documentation. This role involves reviewing historical QC documents, performing gap analyses against current GMP and internal requirements, and building a structured, compliant archive for QC records. The specialist will work cross-functionally with QC, QA, and document control teams to ensure historical method transfer records, analytical methods, and supporting documentation are complete, traceable, and inspection-ready.

• Collect, review, and organize historical paper-based QC method documentation, including legacy method transfer records.
• Categorize and index documents to improve traceability and retrieval.
• Support conversion of legacy records into an organized, compliant archive structure.
• Perform gap analyses of existing QC method documentation against current GMP expectations and internal SOPs and quality standards.
• Identify missing, incomplete, or outdated documentation and clearly document gaps.
• Partner with QC and QA to define remediation strategies for identified gaps.
• Review legacy method transfer packages, analytical methods, protocols, reports, and supporting records.
• Ensure documentation supports method history, ownership, and traceability.
• Assist in aligning legacy documentation with current method lifecycle expectations.
• Build and maintain a GMP-compliant archival system for QC paper records.
• Ensure document retention, version control, and access controls meet regulatory and company requirements.
• Support transition planning for future digitization or document management system integration.
• Collaborate with QC, QA, and Document Control to ensure consistency and compliance.
• Support internal audits and regulatory inspections by retrieving and presenting archived documentation.
• Respond to auditor questions related to historical method documentation and transfer records.

• 5-8 years of previous experience in a regulated pharmaceutical environment.
• Proficiency in GMP and document management.
• Experience in method transfer and method validation.
• Experience in gap analysis and document management.

• Experience with document archives.

The role is based on-site in Wilson, operating within normal business hours. The work environment includes lab spaces that are DEA and GMP controlled.

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

The pay range for this position is $50.00 - $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 Mar 31, 2026.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

Actalent is an equal opportunity employer.

About Actalent

Actalent is a global leader in engineering and sciences services. For more than 40 years, we’ve helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000 extraordinary employees who connect their passion with purpose every day.

Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.

Salary : $50 - $60