Quality Specialist II
About The Position
The Quality Specialist II joins Thermo Fisher Scientific’s Detroit Quality team in the Biologicals and Chemicals Division. The Detroit site manufactures peptones and specialty chemicals for bioproduction and culture media applications and operates under an ISO 13485-certified Quality Management System. This on-site role combines laboratory testing, quality documentation, problem-solving, and collaboration to help ensure products meet quality standards and are ready for customers. The role supports the maintenance and continuous improvement of the ISO 13485:2016 Quality Management System. Responsibilities include reviewing manufacturing and equipment records, supporting product release, preparing Certificates of Analysis, responding to customer quality inquiries, coordinating document changes, participating in validation and audit activities, and creating or updating SOPs. The specialist also performs chemical and biological testing of raw materials and finished products, operates and maintains laboratory equipment, documents and communicates results, and conducts environmental monitoring. The role works with colleagues across Quality, Manufacturing, and other departments to resolve problems and improve processes. A bachelor's degree and at least one year of Quality Control laboratory and/or Quality Assurance experience are required. The position is based on-site in Detroit, Michigan; relocation assistance and employment visa sponsorship are not available.
Requirements
- Bachelor's degree required.
- At least 1 year of experience in a Quality Control laboratory and/or Quality Assurance role required.
- Strong attention to detail and commitment to accuracy and quality.
- Good problem-solving and critical-thinking skills.
- Ability to organize priorities and manage multiple responsibilities in a fast-paced environment.
- Clear written and verbal communication skills, including the ability to prepare accurate technical documentation.
- Comfort using Microsoft Office applications and learning new systems.
- Collaborative, team-oriented approach and willingness to support others.
- Self-motivation, initiative, and desire to continuously learn and improve.
Nice To Haves
- Degree in Biology, Chemistry, Biochemistry, or a related scientific discipline.
- Experience in the pharmaceutical, biotechnology, or life sciences industry.
- Experience with quality management systems, laboratory testing, or regulated manufacturing environments.
- Familiarity with ERP systems, electronic document control, CAPA, or training management software.
Responsibilities
- Help maintain and continuously improve the ISO 13485:2016 Quality Management System.
- Review manufacturing batch records, equipment documentation, calibration records, and other quality-related documents for accuracy and compliance.
- Support timely product release by reviewing test results, completing lot release activities, and preparing Certificates of Analysis.
- Partner with internal teams to respond to customer quality and compliance inquiries, including regulatory documentation and supplier questionnaires.
- Coordinate document changes and updates to maintain accurate, compliant, and efficient quality systems.
- Participate in validation activities, including protocol execution and documentation.
- Create and update standard operating procedures and other quality documents.
- Support internal and external audits and help identify process improvement opportunities.
- Perform chemical and biological testing on raw materials and finished products against quality specifications.
- Conduct laboratory tests including pH, bioburden, loss on drying, growth promotion, titration, and appearance testing.
- Set up, operate, and maintain laboratory equipment according to established procedures.
- Accurately document, review, and communicate laboratory results to support quality decisions and product release.
- Perform environmental monitoring, analyze trends, and report findings.
- Help maintain laboratory readiness by coordinating supplies, equipment needs, and external laboratory services.
- Collaborate with Quality, Manufacturing, and other departments to solve problems and support business priorities.
- Identify opportunities to improve processes, strengthen compliance, and support operational efficiency.
- Contribute to projects and initiatives that support the Detroit site's product quality and customer commitments.
Benefits
- Competitive compensation.
- Annual incentive plan bonus.
- Healthcare benefits.
- A range of employee benefits designed to support colleagues.
- Career development opportunities.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
