Quality specialist III
Thermo Fisher Scientific•Greenville, NC
•Onsite
About The Position
The Quality Specialist III drives quality execution across sterile operations, including manufacturing, filling, packaging, inspection, and associated non-batch-specific activities for commercial and product development services. The role provides quality guidance and expertise to support practical process improvements and continuous improvement initiatives. It includes regular interaction with employees, review and approval of quality documents, batch record review, and support for client quality interactions and regulatory inspections.
Requirements
- Bachelor's degree required, preferably in a scientific-related field.
- At least 5 years of experience, with previous experience in Quality Assurance, Quality Control, or Operations/Manufacturing.
- Equivalent combinations of education, training, and relevant work experience may be considered.
- Hard-working, with demonstrated ownership and responsibility.
- Ability to lead, support, and empower a team or peers.
Nice To Haves
- Previous pharmaceutical industry experience, preferably in aseptic or sterile processes; experience in other regulated environments such as ISO 9001 may be considered.
- Professional certifications such as CQA and training such as Six Sigma.
Responsibilities
- Perform daily quality assessments of facilities, personnel, and documentation in classified and non-classified areas to identify errors or deficiencies and ensure quality and compliance with site procedures and cGMPs.
- Interact daily with employees to assist with troubleshooting, documentation corrections and notes, and guidance on aseptic technique.
- Champion quality culture by helping personnel understand the application of policies and controls.
- Participate in RAPID event response and provide quality guidance for deviation events.
- Review and approve procedures, training documents, and forms of moderate to high complexity.
- Perform quality batch record review.
- Help identify continuous improvement opportunities and participate in practical process improvement initiatives.
- Support client quality interactions and regulatory inspections.
- Develop and maintain batch record review (BRR) SOPs and training materials.
- Partner with operations to improve documentation accuracy and compliance.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
