<p>Job Title: Method Transfer Documentation SpecialistJob Description</p> <p>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.</p> <p>Responsibilities</p> <ul> <li>Collect, review, and organize historical paper-based QC method documentation, including legacy method transfer records. </li><li>Categorize and index documents to improve traceability and retrieval. </li><li>Support conversion of legacy records into an organized, compliant archive structure. </li><li>Perform gap analyses of existing QC method documentation against current GMP expectations and internal SOPs and quality standards. </li><li>Identify missing, incomplete, or outdated documentation and clearly document gaps. </li><li>Partner with QC and QA to define remediation strategies for identified gaps. </li><li>Review legacy method transfer packages, analytical methods, protocols, reports, and supporting records. </li><li>Ensure documentation supports method history, ownership, and traceability. </li><li>Assist in aligning legacy documentation with current method lifecycle expectations. </li><li>Build and maintain a GMP-compliant archival system for QC paper records. </li><li>Ensure document retention, version control, and access controls meet regulatory and company requirements. </li><li>Support transition planning for future digitization or document management system integration. </li><li>Collaborate with QC, QA, and Document Control to ensure consistency and compliance. </li><li>Support internal audits and regulatory inspections by retrieving and presenting archived documentation. </li><li>Respond to auditor questions related to historical method documentation and transfer records. </li></ul> <p>Essential Skills</p> <ul> <li>5-8 years of previous experience in a regulated pharmaceutical environment. </li><li>Proficiency in GMP and document management. </li><li>Experience in method transfer and method validation. </li><li>Experience in gap analysis and document management. </li></ul> <p>Additional Skills & Qualifications</p> <ul> <li>Experience with document archives. </li></ul> <p>Work Environment</p> <p>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.</p> <p>Job Type & Location</p> <p>This is a Contract position based out of Wilson, NC.</p> <p>Pay and Benefits</p> <p>The pay range for this position is $50.00 - $60.00/hr.</p> <p>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)</p> <p>Workplace Type</p> <p>This is a fully onsite position in Wilson,NC.</p> <p>Application Deadline</p> <p>This position is anticipated to close on Mar 17, 2026.</p> <p>About Actalent</p> <p>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.</p> <p>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.</p> <p>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.</p>