Quality Engineer - Clinical Labeling

Thermo Fisher Scientific•Bohemia, NY

9d•Onsite

About The Position

Quality Engineer - Clinical Labeling Division / Site Specific Information The Bohemia, NY site is a key Thermo Fisher Scientific Global Label Services location, specializing in clinical trial labeling design, production, translation, and regulatory support for pharmaceutical and biotechnology companies. As a core Global Label Services site, Bohemia delivers fast, high-quality clinical trial labeling through integrated design, printing, inspection, translation, and regulatory support. The site enables accelerated global studies with advanced OCR inspection, temperature-specific labeling expertise, and dedicated clinical labeling project management. Discover Impactful Work As part of Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. In this role, you will help ensure quality excellence and regulatory compliance across clinical manufacturing operations—supporting our Mission to enable customers to make the world healthier, cleaner, and safer. You’ll collaborate across functions to uphold the highest quality standards while helping deliver clinical trial materials that support life-changing therapies worldwide. Day in the Life Ensure compliance with cGMP, ISO 9001, and applicable global regulatory requirements (FDA, EMA, etc.) Maintain and improve Quality Management Systems (QMS) to ensure consistent quality performance Lead and support deviation investigations, root cause analysis, and CAPA implementation Manage and participate in change control activities and risk assessments (FMEA) Support internal and external audits, including regulatory inspections and customer audits Partner cross-functionally to resolve quality issues and drive continuous improvement initiatives Support validation and qualification activities in alignment with ISPE principles Utilize quality tools, metrics, and statistical analysis to monitor and improve processes Communicate effectively with internal teams, external customers, and regulatory bodies Keys to Success Education Advanced Degree with 3+ years of experience OR Bachelor’s Degree with 5+ years of experience Preferred fields: Engineering, Life Sciences, Chemistry, or related technical discipline Experience Experience in quality assurance within a regulated industry (pharmaceutical, medical device, or biotech) Hands-on experience with: CAPA and deviation management Change control processes Risk management and FMEA Document control systems Internal and external auditing Experience supporting validation and qualification protocols ASQ certifications (CQE, CQA) strongly preferred Knowledge, Skills, Abilities Knowledge Strong understanding of cGMP, ISO standards, and global regulatory expectations Familiarity with ISPE validation and qualification concepts Knowledge of statistical analysis and quality tools Skills Advanced problem-solving and root cause analysis Strong project management and organizational skills Proficiency with quality management systems and MS Office Excellent verbal and written communication skills Abilities Ability to work independently while collaborating across functions High attention to detail with the ability to maintain a broader quality perspective Strong interpersonal skills to effectively partner with internal and external stakeholders Benefits We offer competitive remuneration, an annual incentive plan bonus, healthcare, and a comprehensive total rewards package. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization and outstanding career and development prospects. Benefits include: Medical, Dental, & Vision benefits – effective Day 1 Paid Time Off & Designated Paid Holidays Retirement Savings Plan Tuition Reimbursement Relocation assistance is not provided Must be legally authorized to work in the United States, now or in the future, without sponsorship Must be able to pass a comprehensive background check, including drug screening Compensation and Benefits The salary range estimated for this position based in New York is $83,300.00–$125,000.00. This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes: A choice of national medical and dental plans, and a national vision plan, including health incentive programs Employee assistance and family support programs, including commuter benefits and tuition reimbursement At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards Thank you for your interest as you consider starting a new career journey with us. As the world leader in serving science, our colleagues develop critical solutions through innovation—and build rewarding careers. Discover their extraordinary stories and connection to our Mission to enable our customers to make the world healthier, cleaner and safer. Their work is a story of purpose. What story will you tell? Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.

Requirements

Advanced Degree with 3+ years of experience OR Bachelor’s Degree with 5+ years of experience
Preferred fields: Engineering, Life Sciences, Chemistry, or related technical discipline
Experience in quality assurance within a regulated industry (pharmaceutical, medical device, or biotech)
Hands-on experience with: CAPA and deviation management Change control processes Risk management and FMEA Document control systems Internal and external auditing
Experience supporting validation and qualification protocols
Strong understanding of cGMP, ISO standards, and global regulatory expectations
Familiarity with ISPE validation and qualification concepts
Knowledge of statistical analysis and quality tools
Advanced problem-solving and root cause analysis
Strong project management and organizational skills
Proficiency with quality management systems and MS Office
Excellent verbal and written communication skills
Ability to work independently while collaborating across functions
High attention to detail with the ability to maintain a broader quality perspective
Strong interpersonal skills to effectively partner with internal and external stakeholders
Must be legally authorized to work in the United States, now or in the future, without sponsorship
Must be able to pass a comprehensive background check, including drug screening

Nice To Haves

ASQ certifications (CQE, CQA) strongly preferred

Responsibilities

Ensure compliance with cGMP, ISO 9001, and applicable global regulatory requirements (FDA, EMA, etc.)
Maintain and improve Quality Management Systems (QMS) to ensure consistent quality performance
Lead and support deviation investigations, root cause analysis, and CAPA implementation
Manage and participate in change control activities and risk assessments (FMEA)
Support internal and external audits, including regulatory inspections and customer audits
Partner cross-functionally to resolve quality issues and drive continuous improvement initiatives
Support validation and qualification activities in alignment with ISPE principles
Utilize quality tools, metrics, and statistical analysis to monitor and improve processes
Communicate effectively with internal teams, external customers, and regulatory bodies

Benefits

We offer competitive remuneration, an annual incentive plan bonus, healthcare, and a comprehensive total rewards package.
Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization and outstanding career and development prospects.
Medical, Dental, & Vision benefits – effective Day 1
Paid Time Off & Designated Paid Holidays
Retirement Savings Plan
Tuition Reimbursement
A choice of national medical and dental plans, and a national vision plan, including health incentive programs
Employee assistance and family support programs, including commuter benefits and tuition reimbursement
At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount