Quality Specialist II

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

At Thermo Fisher Scientific team, you’ll discover impactful work, innovative thinking and a culture dedicated to working the right way, for the right reasons - with the customer always top of mind. The work we do matters, like helping customers find cures for cancer, protecting the environment, making sure our food is safe and delivering COVID-19 solutions. As the world leader in serving science, with the largest investment in R&D in the industry, our colleagues are empowered to realize their full potential as part of a fast-growing, global organization that values passion and unique contributions. Our commitment to our colleagues across the globe is to provide the resources and opportunities they need to make a difference in our world while building a fulfilling career with us.

Location/Division Specific Information:

Clinical Labeling Services, part of the Clinical Trials Division, located in Bohemia, New York provides leading clinical label design, production, and management services for the pharmaceutical and biotechnology industry. Our advanced inspection software, full in-house variable and non-variable print capabilities, and proprietary translation and regulatory approval system are designed to reduce overall clinical trial label cycle times.

How will you make an impact?

The Quality Specialist is responsible for the compliance of the Clinical Label Services Quality Management System (QMS), which includes quality assurances practices, clinical labels regulatory compliance, audits, supplier management, client change notification program, data integrity, among others.

A Day in the Life:

• Develop and lead metrics related to CLS Quality compliance and present to Senior management on a scheduled basis.
• Support site Data Integrity Initiatives.
• Assist in taking part in the internal and external audit programs.
• Complete action items associated with investigation reports related to compliance actions.
• Establish new procedures and update existing ones as applicable.
• Support review and implementation of corporate and division policies.
• Maintain site compliance with GxP related to US and EU clinical labeling.
• Review all Quality Agreements and collaborate with Client Services to ensure all client-specific requirements are included.
• Support quality on the Change Control Committee.
• Support the routing and approval of client Change Notifications.
• Assist the quality team with any issues related to Global TrackWise or Documentum.
  
  

Keys to Success:

Education & Experience

• Bachelor of Science (required) Engineering or Life Sciences- related field
• Master of Science Preferred
  
  

Knowledge, Skills, Abilities

• 4 years of experience with Management Systems
• Knowledge of directives (EU-GMP, US FDA 21 CFR) including Part 11 requirements.
• Strong interpersonal, verbal, and written communication skills.
• Must demonstrate excellent proficiency in personal computer applications such as Microsoft Outlook, Word, Excel, and PowerPoint.
• Ability to apply principles of logic or scientific thinking to a wide range of intellectual and practical problems, including root cause analysis.
  
  

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!

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000 colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Compensation And Benefits

The salary range estimated for this position based in New York is $66,000.00–$99,000.00.

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