Quality Project Lead

Work Schedule

Environmental Conditions

Job Description

Quality Project Lead

Division / Site Specific Information

With the support of over 800 talented employees Thermo Fisher Scientifics 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 youll discover meaningful work that makes a positive impact on a global 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

• Bachelors 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.