Quality specialist III
About The Position
As part of Thermo Fisher Scientific’s Drug Product Division – North America, the Quality Specialist III drives quality execution across sterile operations, including manufacturing, filling, packaging, and inspection, as well as associated non-batch-specific activities for commercial and product development services products. The position provides quality guidance and expertise for practical process improvements and continuous improvement initiatives. The role conducts daily quality assessments of facilities, personnel, and documentation in classified and non-classified areas to identify deficiencies and support compliance with site procedures and cGMPs. It interacts with employees to troubleshoot issues, correct documentation, and provide guidance on aseptic technique; supports deviation response; reviews and approves quality documents; reviews batch records; and supports client quality interactions and regulatory inspections. The position also develops and maintains batch record review procedures and training materials and partners with operations to improve documentation accuracy and compliance.
Requirements
- Bachelor’s degree required, preferably in a scientific-related field.
- At least 5 years of experience, with prior experience in Quality Assurance, Quality Control, or Operations/Manufacturing.
- Previous pharmaceutical industry experience; experience with aseptic or sterile processes is strongly preferred. Experience in other regulated environments, such as ISO 9001, may be considered.
- Demonstrated ownership and responsibility, and ability to lead, support, and empower a team or peers.
- Ability to perform the stated physical activities, including prolonged periods of standing, walking, stooping, kneeling, crouching, grasping, typing, sitting, reaching, talking, and hearing; moving light to medium weights of 10–35 pounds; and using a keyboard, computer monitor, and equipment or reading materials for prolonged periods.
Nice To Haves
- Professional certifications such as CQA.
- 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 or notes, and guidance on aseptic technique.
- Promote 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.
- Identify continuous improvement opportunities and participate in practical process improvement initiatives.
- Support client quality interactions and regulatory inspections.
- Develop and maintain 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
Senior
