Sr Quality Specialist

About the role

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join colleagues in bringing the company’s mission to life every day to enable customers to make the world healthier, cleaner and safer. The Senior Quality Specialist – Project Lead provides technical leadership and quality oversight for a sterile manufacturing environment, ensuring compliance with pharmaceutical regulations and maintaining full company compliance to prevent regulatory actions that could hinder product quality, cause stoppages, or affect customer satisfaction.

Responsibilities

• Lead projects of moderate complexity, conducting compliance assessments and making decisions on regulatory requirements.
• Draft new procedures and ensure adherence to current regulations.
• Oversee the quality of methods, processes, materials, and products by coordinating and reviewing group operations.
• Provide staff training and assess/improve systems and processes.
• Review and approve procedures, training documents, forms, deviations, and change controls of moderate to high complexity.
• Perform risk assessments and implement appropriate 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.
• Make decisions on compliance issues within facilities, equipment, manufacturing, and support areas, considering risk levels.

Education

Bachelor’s degree required, preferably in technology, engineering, a scientific field, or a related area. Equivalent combinations of training and meaningful work experience may be considered if at least a bachelor’s degree is obtained.

Experience

Minimum 5 years of experience in Quality Assurance, Quality Control, or Operations/Manufacturing.

Knowledge, Skills, and Abilities

• Project management expertise.
• Strong knowledge of regulatory requirements and quality standards.
• Excellent interpersonal and leadership abilities.
• Attention to detail, organizational skills, and effective communication.
• Negotiation skills and understanding of quality systems and technical writing.
• Professional certifications (e.g., CQA) and Six Sigma training are beneficial.
• Demonstrated commitment to the principles of Integrity, Respect, and Excellence.
• Ability to work independently and remain firm in complex, fast‑paced situations.

Physical Requirements / Work Environment

Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods; manipulation (lift, carry, move) of light to medium weights of 10–35 pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods; ability to sit, reach with hands and arms, talk, and hear for prolonged periods.

Work Schedule

Standard (Mon‑Fri) schedule.

Environmental Conditions

Office environment.