Senior QC Scientist: Method Lifecycle & GMP Leadership

Regulatory Jobs; High Point (NC); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

Medical, Dental, & Vision benefits

Paid Time Off & Holidays

Retirement Savings Plan

Tuition Reimbursement

Job summary

Thermo Fisher Scientific in North Carolina is seeking a senior Quality Control Specialist to lead analytical data evaluation and quality system activities across pharma development and manufacturing. You will drive method lifecycle projects, risk assessments, and change controls, while mentoring junior staff and ensuring compliance with GMP, GLP, and data integrity standards.

Expectation includes authoring and revising SOPs and QC documents, supporting SAP quality processes, and communicating

Qualifications

• Minimum 8 years of experience in analytical testing, quality control, or related pharmaceutical QA.
• Strong knowledge of GMP, GLP, data integrity and quality systems.
• Experience with method lifecycle activities, transfer, validation and change control.
• Excellent written and verbal communication and leadership skills.

Responsibilities

• Interpret, verify, and approve analytical data; lead quality initiatives through group and department project teams; mentor junior team members.
• Lead method lifecycle activities, including transfer, qualification, validation, and implementation of new or revised test procedures.
• Assess compendial updates, author revision protocols/reports, and initiate changes to procedures and quality documents.
• Own or support change controls for test procedures, specifications, reduced testing programs, and client-initiated changes.
• Collaborate with technical, quality, and client-facing teams on supplier/material changes and risk assessments.
• Author and revise quality documents, SOPs, protocols, and reports; manage electronic document systems.
• Support SAP quality processes and master data updates; maintain QA documentation accuracy.
• Communicate technical conclusions clearly through reports and client/external partner discussions.

Skills

Quality leadership

GMP knowledge

GLP knowledge

Data integrity

Cross-functional collaboration

SOPs & documentation

Mentoring

Communication skills

Education

Bachelor's degree in physical science

Master's degree preferred

Tools

SAP quality module

HPLC

GC

LC/MS

Job description

Thermo Fisher Scientific in North Carolina is seeking a senior Quality Control Specialist to lead analytical data evaluation and quality system activities across pharma development and manufacturing. You will drive method lifecycle projects, risk assessments, and change controls, while mentoring junior staff and ensuring compliance with GMP, GLP, and data integrity standards.

Expectation includes authoring and revising SOPs and QC documents, supporting SAP quality processes, and communicating