Quality Specialist I

Thermo Fisher Scientific • Florence, SC

1d

About The Position

Under general supervision, the Quality Specialist I provides manufacturing technical support and quality assurance oversight to help meet good business practices and applicable regulatory requirements. The role supports one or more areas related to the manufacturing, testing, disposition, quality systems, or distribution of bulk drug substance.

The specialist applies technical knowledge to promote compliance with company policies, procedures, and regulatory requirements. The role maintains quality management system documentation and records, reviews batch records, performs or supports investigations, monitors business process performance, and helps resolve quality issues affecting materials, products, environmental monitoring, or systems. The position also supports training, audits and inspections, quality system tools, procedural updates, and continuous improvement while maintaining inspection readiness.

Requirements

• High school diploma or equivalent required.
• High school diploma with 3–5 years of experience in pharmaceutical or biological manufacturing, or another regulated industry; alternatively, a bachelor's degree in a technical science or engineering field with 0–3 years of Quality Assurance experience.
• Experience conducting quality investigations and root cause analysis.
• Thorough knowledge of FDA, EMA, and international GMP regulations.
• Ability to review and approve GMP documentation, batch records, and quality records.
• Strong understanding of quality management systems and tools, such as CAPA and change control.
• Excellent documentation and technical writing skills.
• Proficiency with quality systems software and Microsoft Office applications.
• Strong analytical and problem-solving abilities and attention to detail.
• Strong verbal and written communication skills.
• Ability to work independently and collaborate effectively across functions.
• Knowledge of environmental monitoring and contamination control principles.
• Flexibility to work various shifts as needed to support manufacturing operations.
• Ability to gown and work in controlled manufacturing environments when required.
• Ability to stand, walk, and occasionally lift up to 25 pounds.
• Sound judgment and decision-making skills.
• Commitment to maintaining a quality-focused culture and driving continuous improvement.
• Fluency in English.
• Must be legally authorized to work in the United States now or in the future without sponsorship.
• Must be able to pass a comprehensive background check, including drug screening.

Nice To Haves

• Bachelor's degree preferred, particularly in Chemistry, Biology, Engineering, Life Sciences, or a related scientific field.
• Relevant certifications, such as ISO auditor or Six Sigma.
• Additional language skills.

Responsibilities

• Provide technical support and quality assurance oversight for manufacturing, testing, batch disposition, quality systems, qualification and validation, or distribution of bulk drug substance.
• Maintain quality management system documentation and records required for product development, production, and distribution.
• Support archival and retrieval of documentation and drawings from approved storage areas.
• Monitor and analyze business process performance measures and notify management of potential quality or regulatory issues.
• Review batch records and perform appropriate investigations to help ensure products are manufactured in compliance with regulations and GMP requirements.
• Provide quality assurance support to resolve raw material, in-process material, bulk and final product, environmental, and system issues.
• Assist in writing and revising site SOPs and other procedures.
• Administer, document, and maintain the company Quality Systems in conformance with regulatory requirements and company policies.
• Troubleshoot and direct resolution of quality issues through interdepartmental and cross-functional partnerships.
• Support Site Training in the development, delivery, and maintenance of Quality training programs, including CAPA and GMP training.
• Participate in audits and inspections performed by clients and regulatory agencies.
• Participate in the execution or administration of corporate Quality System tools such as TrackWise, Documentum, and EDMS.
• Provide input to personal performance goals and departmental objectives, and collaborate with management to establish and meet targets and timelines.
• Participate in the design and implementation of departmental and cross-functional initiatives.
• Maintain inspection readiness.
• Perform other duties as required.

Benefits

• Medical, dental, and vision benefits effective Day 1.
• Paid time off and designated paid holidays.
• Retirement savings plan.
• Tuition reimbursement.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED