Senior Quality Specialist: Project Lead, Sterile Ops

Regulatory Jobs; Greenville (NC); On-site; USD 85,000 - 120,000; Full time

Job summary

Thermo Fisher Scientific in North Carolina seeks a Senior Quality Specialist – Project Lead to provide technical leadership and Quality oversight for a Sterile Manufacturing Environment, ensuring compliance with pharmaceutical regulations and maintaining product quality and patient safety.

The role involves leading projects, reviewing procedures and training documents, performing risk assessments, and acting as a resource for system support and new product introduction in a fast-paced

Qualifications

• Bachelor degree required, preferably in technology, engineering, scientific field or related area.
• Minimum 5 years of experience in Quality Assurance, Quality Control, or Operations/Manufacturing required.
• Equivalent combinations of training, and meaningful work experience may be considered if at least a bachelor degree is acquired.
• Professional certifications (e.g., CQA) and training in Six Sigma are beneficial.

Responsibilities

• Leads projects of moderate complexity, conducting compliance assessments, making decisions on regulatory requirements, drafting new procedures, and ensuring adherence to current regulations.
• Oversees the quality of methods, processes, materials, and products by coordinating and reviewing group operations, providing staff training, and assessing/improving systems and processes.
• Responsible for reviewing and approving procedures, training documents, forms, deviation, and change control of moderate to high complexity.
• Performs risk assessments and takes appropriate actions to ensure adequate controls related to product quality, safety, and business risks.
• Act as a technical resource for system support and new product introduction by interpreting regulatory requirements and establishing systems.
• Makes decisions on compliance issues within facilities, equipment, manufacturing, and support areas, considering the level of risks related to compliance and product quality.

Skills

Project management

Regulatory knowledge

Quality standards

Leadership

Communication

Quality systems

Technical writing

Education

Bachelor's degree

Job description

Thermo Fisher Scientific in North Carolina seeks a Senior Quality Specialist – Project Lead to provide technical leadership and Quality oversight for a Sterile Manufacturing Environment, ensuring compliance with pharmaceutical regulations and maintaining product quality and patient safety.

The role involves leading projects, reviewing procedures and training documents, performing risk assessments, and acting as a resource for system support and new product introduction in a fast-paced