Sr. QA Specialist - Customer Support

Thermo Fisher Scientific • Greenville, NC

89d

About The Position

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.

Requirements

• 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.

Nice To Haves

• 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.

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.

Benefits

• Competitive remuneration
• Annual incentive plan bonus
• Healthcare, and a range of employee benefits
• Medical, Dental, & Vision benefits-effective Day 1
• Paid Time Off & Designated Paid Holidays
• 401K
• Tuition Reimbursement
• Employee Referral Bonus
• Career Advancement Opportunities

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Computer and Electronic Product Manufacturing
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees