Quality Project Lead
Thermo Fisher Scientific, Cincinnati, OH, United States
This job is with Thermo Fisher Scientific, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Job Description
Quality Project Lead
Division / Site Specific Information
With the support of over 800 talented employees, Thermo Fisher Scientific’s
Oral Solid Dose (OSD) site in Cincinnati, Ohio
provides comprehensive drug development and commercial manufacturing services. The site specializes in advanced dosage forms including controlled and sustained release products, osmotic release dosage forms (laser drilling), liquid-filled hard capsules, controlled substances, and abuse-deterrent technologies.
Discover Impactful Work
As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. In this role, you will help ensure the highest quality standards across our operations, supporting our Mission to enable our customers to make the world healthier, cleaner, and safer. As a
Quality Specialist III , you will collaborate cross-functionally to strengthen quality systems, drive continuous improvement, and ensure regulatory compliance in a highly regulated pharmaceutical manufacturing environment.
A Day in the Life
Maintain quality systems in compliance with cGMPs, GxP regulations, ISO standards, global regulatory requirements, and company policies
Lead and support investigations related to deviations, nonconformances, and quality events using sound root cause analysis techniques
Manage and support CAPA, change control, and risk assessment activities
Author, review, and approve SOPs, investigation reports, and quality documentation
Conduct and host internal audits, external audits, and regulatory inspections
Analyze quality data, perform trending, and report quality metrics to support continuous improvement
Collaborate with cross-functional teams to implement corrective and preventive actions
Foster a culture of quality excellence and continuous improvement across the organization
Keys to Success
Education
Advanced Degree with a minimum of 3 years of experience
OR
Bachelor’s Degree with a minimum of 5 years of experience
Preferred fields of study: Life Sciences, Engineering, Chemistry, Biology, or related technical discipline
Experience
Experience in quality assurance or quality control within regulated industries (pharmaceutical, biotech, or medical device preferred)
Proven experience with CAPA, deviation management, change control, and quality management systems
Experience conducting and hosting internal and external audits and regulatory inspections
Project management experience preferred
Knowledge, Skills, and Abilities
Knowledge
Strong knowledge of GMP/GxP regulations and ISO standards (9001/13485)
Understanding of risk assessment methodologies and continuous improvement tools
Skills
Proficiency with quality systems software (e.g., TrackWise, document control systems)
Strong technical writing skills for SOPs, investigations, and quality reports
Proficiency in statistical analysis, data trending, and quality metrics reporting
Strong verbal and written communication skills
Abilities
Advanced problem-solving and root cause analysis capabilities
Ability to work independently and guide cross-functional teams
Strong interpersonal skills with the ability to collaborate across functions and levels
High attention to detail and commitment to quality excellence
Physical Requirements / Work Environment
Ability to work in a pharmaceutical manufacturing environment
Ability to wear appropriate personal protective equipment (PPE) as required
Benefits
Thermo Fisher Scientific offers competitive remuneration, an annual incentive plan, and comprehensive benefits starting Day 1, including:
Medical, Dental, and Vision Insurance
Paid Time Off and Designated Paid Holidays
Retirement Savings Plan
Tuition Reimbursement
Relocation assistance is not provided
Must be legally authorized to work in the United States without sponsorship
Must be able to pass a comprehensive background check, including a drug screening
Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization and outstanding career and development opportunities. Our culture is built on integrity, intensity, involvement, and innovation.
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Job Description
Quality Project Lead
Division / Site Specific Information
With the support of over 800 talented employees, Thermo Fisher Scientific’s
Oral Solid Dose (OSD) site in Cincinnati, Ohio
provides comprehensive drug development and commercial manufacturing services. The site specializes in advanced dosage forms including controlled and sustained release products, osmotic release dosage forms (laser drilling), liquid-filled hard capsules, controlled substances, and abuse-deterrent technologies.
Discover Impactful Work
As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. In this role, you will help ensure the highest quality standards across our operations, supporting our Mission to enable our customers to make the world healthier, cleaner, and safer. As a
Quality Specialist III , you will collaborate cross-functionally to strengthen quality systems, drive continuous improvement, and ensure regulatory compliance in a highly regulated pharmaceutical manufacturing environment.
A Day in the Life
Maintain quality systems in compliance with cGMPs, GxP regulations, ISO standards, global regulatory requirements, and company policies
Lead and support investigations related to deviations, nonconformances, and quality events using sound root cause analysis techniques
Manage and support CAPA, change control, and risk assessment activities
Author, review, and approve SOPs, investigation reports, and quality documentation
Conduct and host internal audits, external audits, and regulatory inspections
Analyze quality data, perform trending, and report quality metrics to support continuous improvement
Collaborate with cross-functional teams to implement corrective and preventive actions
Foster a culture of quality excellence and continuous improvement across the organization
Keys to Success
Education
Advanced Degree with a minimum of 3 years of experience
OR
Bachelor’s Degree with a minimum of 5 years of experience
Preferred fields of study: Life Sciences, Engineering, Chemistry, Biology, or related technical discipline
Experience
Experience in quality assurance or quality control within regulated industries (pharmaceutical, biotech, or medical device preferred)
Proven experience with CAPA, deviation management, change control, and quality management systems
Experience conducting and hosting internal and external audits and regulatory inspections
Project management experience preferred
Knowledge, Skills, and Abilities
Knowledge
Strong knowledge of GMP/GxP regulations and ISO standards (9001/13485)
Understanding of risk assessment methodologies and continuous improvement tools
Skills
Proficiency with quality systems software (e.g., TrackWise, document control systems)
Strong technical writing skills for SOPs, investigations, and quality reports
Proficiency in statistical analysis, data trending, and quality metrics reporting
Strong verbal and written communication skills
Abilities
Advanced problem-solving and root cause analysis capabilities
Ability to work independently and guide cross-functional teams
Strong interpersonal skills with the ability to collaborate across functions and levels
High attention to detail and commitment to quality excellence
Physical Requirements / Work Environment
Ability to work in a pharmaceutical manufacturing environment
Ability to wear appropriate personal protective equipment (PPE) as required
Benefits
Thermo Fisher Scientific offers competitive remuneration, an annual incentive plan, and comprehensive benefits starting Day 1, including:
Medical, Dental, and Vision Insurance
Paid Time Off and Designated Paid Holidays
Retirement Savings Plan
Tuition Reimbursement
Relocation assistance is not provided
Must be legally authorized to work in the United States without sponsorship
Must be able to pass a comprehensive background check, including a drug screening
Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization and outstanding career and development opportunities. Our culture is built on integrity, intensity, involvement, and innovation.