Quality Engineer Clinical Labeling
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Job Location:
Bohemia, NY - USA
Monthly Salary:
$ 83300 - 125000
Posted on:
13 hours ago
Vacancies:
1 Vacancy
Job Summary
Work Schedule
First Shift (Days)Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards OfficeJob Description
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 youll discover meaningful work that makes a positive impact on a global this role you will help ensure quality excellence and regulatory compliance across clinical manufacturing operationssupporting our Mission to enable customers to make the world healthier cleaner and safer.
Youll 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
Bachelors 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 $83300.00$125000.00.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: Experience:
IC
Key Skills
- APQP
- Quality Assurance
- Six Sigma
- ISO 9001
- PPAP
- Minitab
- Root cause Analysis
- ISO 13485
- Quality Systems
- Quality Management
- As9100
- Manufacturing
About Company
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