Quality Specialist II

Thermo Fisher Scientific•Detroit, MI

2d•Onsite

About The Position

The Quality Specialist II is an on-site role with Thermo Fisher Scientific’s Biologicals and Chemicals Division in Detroit, Michigan. The Detroit site manufactures peptones and specialty chemicals used in bioproduction and culture media applications and operates under an ISO 13485-certified Quality Management System. This position combines hands-on chemical and biological laboratory testing with quality assurance, documentation, product release, and cross-functional collaboration to help ensure products meet established standards and are available to customers on time. The role supports and improves the ISO 13485:2016 Quality Management System; reviews batch, equipment, calibration, and other quality records; supports lot release and prepares Certificates of Analysis; and assists with customer quality inquiries, document control, validation, audits, and SOPs. Laboratory work includes testing raw materials and finished products, operating and maintaining equipment, documenting results, and performing environmental monitoring. The specialist also works with Quality, Manufacturing, and other teams to address issues and identify process improvements. The position follows a standard Monday–Friday schedule and requires adherence to Good Manufacturing Practices and safety standards. Some personal protective equipment is required. Relocation assistance and employment visa sponsorship are not available for this position.

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 preparation of 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.
Ability to adhere to Good Manufacturing Practices and safety standards and use required personal protective equipment.

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 documentation for accuracy and compliance.
Review test results and complete lot-release activities to support timely product release.
Prepare Certificates of Analysis.
Work with internal teams to respond to customer quality and compliance inquiries, including regulatory documentation and supplier questionnaires.
Coordinate document changes and updates.
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 improvements.
Perform chemical and biological testing on raw materials and finished products against quality specifications.
Conduct laboratory tests such as pH, bioburden, loss on drying, growth promotion, titration, and appearance testing.
Set up, operate, and maintain laboratory equipment according to established procedures.
Document, review, and communicate laboratory results to support quality decisions and timely product release.
Perform environmental monitoring, analyze trends, and report findings to support manufacturing operations.
Coordinate laboratory supplies, equipment needs, and external laboratory services to maintain laboratory readiness.
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 service.