Quality Project Lead

Regulatory Jobs; Cincinnati (OH); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Healthcare

Annual incentive plan bonus

Job summary

Thermo Fisher Scientific's Cincinnati site, specializing in oral solid dosage development and manufacturing, is seeking a Quality Specialist III to uphold quality and regulatory standards.

You will partner with cross-functional teams to investigate issues, drive CAPA and change controls, perform audits, and contribute to continuous improvement under GMP/GxP and ISO requirements.

Qualifications

• Quality assurance and/or quality control experience in a regulated industry; pharma/biotech experience preferred
• Experience with quality management systems, CAPA, deviation management, and change control
• Strong root cause analysis, investigations, and corrective action implementation
• Experience conducting and hosting internal/external audits and regulatory inspections
• Client-facing and project management experience preferred
• Knowledge of GMP/GxP regulations and ISO 9001/13485
• Proficiency in data trending and quality metrics reporting
• Technical writing skills for SOPs and investigation reports

Responsibilities

• Investigate quality issues using root cause analysis
• Manage CAPA, deviation, and change control processes
• Conduct internal and external audits and support regulatory inspections
• Author and maintain SOPs and investigation reports
• Analyze quality data, trends, and metrics to identify opportunities
• Apply risk assessment methodologies and continuous improvement tools
• Collaborate with cross-functional teams to implement corrective actions
• Support GMP/GxP and ISO standards compliance

Skills

Root Cause Analysis

CAPA management

Deviation management

Change control

Audit execution

Regulatory inspections

SOP writing

Data analysis

Quality metrics

TrackWise

Document control

MS Office

Cross-functional collaboration

GMP/GxP knowledge

Education

Advanced degree + 3 years experience

Bachelor’s degree + 5 years experience

Life Sciences/Engineering/Chemistry/Biology field preferred

Tools

TrackWise

Document control systems

Microsoft Office

Job description

Work Schedule

Standard Office Hours (40/wk)

Environmental Conditions

Office

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Division/Site Specific Information

The Cincinnati site specializes in making oral solid drugs and developing them for the Pharma Services Group. Thermo Fisher Scientific’s oral solid dose (OSD) site in Cincinnati, Ohio, supported by over 800 employees, offers various drug development and commercial manufacturing services. These services include controlled and sustained release solid oral dosage forms, osmotic release dosage forms (laser drilling), liquid fill hard capsules, controlled substances manufacturing, and abuse-deterrent dosage forms.

Discover Impactful Work:

As a Quality Specialist III, you will help ensure high quality standards across our operations by maintaining regulatory compliance and driving continuous improvement of quality systems. You will partner with cross-functional teams to investigate quality issues, implement corrective actions, and foster a culture of quality excellence in support of our Mission.

A Day in the Life:

In this role, you will support quality systems and compliance activities across the organization, applying your technical expertise to investigations, audits, documentation, and continuous improvement initiatives.

• Investigate quality issues using root cause analysis and appropriate investigation techniques
• Manage and support CAPA, deviation, and change control processes
• Conduct and host internal and external audits and support regulatory inspections
• Author and maintain SOPs, investigation reports, and other quality documentation
• Analyze quality data, trends, and metrics to identify opportunities for improvement
• Apply risk assessment methodologies and continuous improvement tools
• Collaborate with and guide cross-functional teams in implementing effective corrective actions
• Support ongoing compliance with GMP/GxP regulations, ISO standards, and applicable quality system requirements

Keys to Success:

Education

• Advanced degree plus 3 years of relevant experience, or bachelor’s degree plus 5 years of relevant experience
• Degree in Life Sciences, Engineering, Chemistry, Biology, or a related technical field preferred

Experience

• Quality assurance and/or quality control experience within a regulated industry; pharmaceutical, medical device, or biotech experience preferred
• Experience with quality management systems, CAPA, deviation management, and change control
• Demonstrated expertise in root cause analysis, investigations, and corrective action implementation
• Experience conducting and hosting internal/external audits and regulatory inspections
• Client-facing experience preferred
• Project management experience preferred

Knowledge, Skills, Abilities

• Strong knowledge of GMP/GxP regulations, ISO 9001/13485, and other relevant quality system requirements
• Proficiency in statistical analysis, data trending, and quality metrics reporting
• Strong technical writing skills for SOPs, investigation reports, and other quality documentation
• Advanced problem-solving skills with strong attention to detail
• Excellent verbal and written communication and strong interpersonal skills
• Ability to work independently and collaborate with or guide cross-functional teams
• Proficiency with quality systems software such as TrackWise and document control systems, as well as Microsoft Office
• Knowledge of risk assessment methodologies and continuous improvement tools

Physical Requirements/Work Environment

• Ability to work in manufacturing environments and comply with PPE requirements as needed

Competencies

• Quality focused
• Collaborative
• Accountable
• Analytical problem solver
• Effective communicator
• Continuous improvement mindset

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation! See our website for more information on Benefits & Total Rewards

Location, Work Authorization & Pre-Employment Requirements

Please review the following requirements before applying:

• Relocation: Relocation assistance is not available for this position.
• Work Authorization: Applicants must be legally authorized to work in the United States without current or future employer-sponsored work authorization.
• Pre-Employment Screening: Employment is contingent upon successful completion of all applicable pre-employment requirements, including a background check and drug screening, in accordance with company policy and applicable law.