Incoming MethodTransfer Specialist

QRC Group, LLC • Añasco, PR

21h

About The Position

The Incoming Process Transfer Specialist is responsible for coordinating, executing, and documenting process transfer activities related to incoming materials, components, and raw materials used in regulated manufacturing operations. This role ensures that specifications, testing strategies, supplier processes, and material controls are successfully transferred, implemented, and maintained in alignment with quality system requirements and regulatory expectations.

Requirements

• Bachelor’s or Master’s degree in Engineering, Chemistry, Materials Science, Industrial Engineering, or related scientific/technical discipline.
• Five years of experience in a regulated manufacturing environment (pharmaceutical, biotech, medical devices, or related industry).Experience in incoming materials, supplier quality, technical operations, or process transfer activities.
• Knowledge of raw material qualifications and supplier management processes is preferred.
• Strong analytical, investigative, and problem‑solving skills.
• Excellent technical writing and documentation skills.

Nice To Haves

• Knowledge of raw material qualifications and supplier management processes is preferred.

Responsibilities

• Lead and coordinate incoming process transfer activities for raw materials.
• Develop and execute transfer protocols, acceptance criteria, and documentation packages to ensure successful implementation of new or revised incoming material processes.
• Facilitate knowledge transfer between sending and receiving sites, including suppliers, contract manufacturers, and internal facilities.
• Support onboarding of new suppliers and materials by ensuring alignment of specifications, sampling plans, testing methods, and quality requirements.
• Review, revise, and approve incoming material specifications according to internal standards, compendial requirements, and regulatory guidelines.
• Evaluate supplier process capabilities and ensure that supplier documentation (e.g., CoAs, process flow, controls) meets quality and regulatory expectations.
• Collaborate with QC to define appropriate testing strategies, sampling plans, and verification requirements for incoming materials.
• Participate in risk assessments to determine material criticality, supplier quality requirements, and controls needed for qualification or re-qualification.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level