Quality Specialist II, Product Release and Label Managment
About The Position
Work That Matters At Thermo Fisher Scientific, our Mission is to enable our customers to make the world healthier, cleaner, and safer. Every day, our teams help improve patient outcomes through innovative diagnostic solutions that support healthcare providers and transplant patients worldwide. As a Quality Specialist II – Product Release & Label Management, you will play a key role in ensuring our products meet the highest quality and regulatory standards before they reach customers. If you enjoy solving problems, collaborating across teams, and driving quality excellence in a regulated environment, we'd like to hear from you. What You'll Do In this role, you will help ensure products are released accurately, efficiently, and in compliance with quality requirements. You will: Review production, packaging, labeling, and laboratory documentation to support final product release. Perform product and label inspections to verify compliance with approved specifications. Review and approve label submissions and updates within label management systems. Release finished and semi-finished products in accordance with established quality standards. Assemble, review, scan, and archive Device History Records (DHRs), ensuring records are complete, accurate, and audit-ready. Support Non-Conformance (NC) and Corrective and Preventive Action (CAPA) investigations and related quality initiatives. Identify opportunities for process improvement and contribute to continuous improvement projects. Develop, revise, and maintain Standard Operating Procedures (SOPs), work instructions, and quality documentation. Support regulatory inspections, customer audits, and internal audits through document preparation and presentation. Partner with Manufacturing, Packaging, Labeling, Quality Control, Regulatory Affairs, and other cross-functional teams to resolve quality issues and maintain production schedules. Participate in Material Review Board (MRB) activities, new product introductions, and quality system improvements. Maintain compliance with GMP, quality system, safety, and regulatory requirements.
Requirements
- Bachelor's degree in Biology, Life Sciences, Chemistry, Biomedical Sciences, or another related scientific discipline
- 3+ years of experience in Quality Assurance, Quality Control, Manufacturing Quality, or a related function within a GMP-regulated environment.
- Strong analytical, organizational, and problem-solving skills.
- Ability to manage multiple priorities and work effectively in a fast-paced environment.
- Strong written and verbal communication skills.
- Ability to collaborate effectively across diverse teams and functions.
Nice To Haves
- Experience in medical device, diagnostics, biotechnology, pharmaceutical, or other regulated manufacturing industries.
- Experience reviewing batch records, Device History Records (DHRs), or product release documentation.
- Knowledge of GMP, FDA regulations, ISO 13485, CAPA, Non-Conformance processes, and quality systems.
- Experience with electronic quality management systems (eQMS), document control systems, or label management software.
- Experience supporting audits, inspections, or regulatory compliance activities.
Responsibilities
- Review production, packaging, labeling, and laboratory documentation to support final product release.
- Perform product and label inspections to verify compliance with approved specifications.
- Review and approve label submissions and updates within label management systems.
- Release finished and semi-finished products in accordance with established quality standards.
- Assemble, review, scan, and archive Device History Records (DHRs), ensuring records are complete, accurate, and audit-ready.
- Support Non-Conformance (NC) and Corrective and Preventive Action (CAPA) investigations and related quality initiatives.
- Identify opportunities for process improvement and contribute to continuous improvement projects.
- Develop, revise, and maintain Standard Operating Procedures (SOPs), work instructions, and quality documentation.
- Support regulatory inspections, customer audits, and internal audits through document preparation and presentation.
- Partner with Manufacturing, Packaging, Labeling, Quality Control, Regulatory Affairs, and other cross-functional teams to resolve quality issues and maintain production schedules.
- Participate in Material Review Board (MRB) activities, new product introductions, and quality system improvements.
- Maintain compliance with GMP, quality system, safety, and regulatory requirements.
Benefits
- A choice of national medical and dental plans, and a national vision plan, including health incentive programs
- Employee assistance and family support programs, including commuter benefits and tuition reimbursement
- At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
- Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
- Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
