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Quality Project Lead at Thermo Fisher Scientific, Cincinnati, OH

Quality Project Lead at Thermo Fisher Scientific in Cincinnati, OH. Full-time. Est. up to $160k. Apply with swipeandhired.

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.