Sr Quality Specialist

Regulatory Toolkit; 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

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Location/Division Specific Information

The Drug Product Division (DPD) is one of the three divisions that make up the Pharma Services Group (PSG) in the Biopharma Services (BPS) Sector at Thermo Fisher. We have more than 9,000 colleagues across 13 sites who specialize in taking sterile injectable, oral solid dose and softgel drug products from development to commercialization.

As the Contract Development Manufacturing Organization (CDMO) market leader, we have built a reputation for scientific and technical excellence, and DPD has benefitted from capital investments in capacity expansion and new capabilities to ensure our long-term growth as we continue to meet our customers' evolving needs.

How Will You Make an Impact

The Senior Quality Specialist – Project Lead at Thermo Fisher Scientific plays a crucial role in providing technical leadership and Quality oversight for a Sterile Manufacturing Environment, ensuring compliance with pharmaceutical regulations. This position is responsible for maintaining full company compliance to prevent regulatory actions that could hinder product quality, lead to stoppages, or impact customer satisfaction.

A Day in the Life

• 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.

Education

• Bachelor degree required, preferably in technology, engineering, scientific field or related area.

Experience

• 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.

Knowledge, Skills, Abilities

• Project management expertise


• Strong knowledge of regulatory requirements and quality standards


• Excellent interpersonal and leadership abilities, attention to detail, organizational skills, effective communication skills, negotiation skills, and understanding of quality systems and technical writing.


• Professional certifications (e.g., CQA) and training in Six Sigma are beneficial.


• Demonstrated commitment to fundamental principles of Integrity, Respect, and Excellence is essential.


• Ability to work independently and to remain firm in complex situations is required in this fast-paced environment.

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 of time; 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 of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.