Quality Engineer Clinical Labeling
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Job Location:
Bohemia, NY - USA
Monthly Salary:
$ 83300 - 125000
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Work Schedule
First Shift (Days)Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards OfficeJob Description
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 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 serve as a Quality subject matter expert ensuring quality excellence and regulatory compliance across clinical manufacturing operations.
You will provide independent QA oversight of qualification/validation activities drive process improvements through structured analysis and process mapping and lead supplier quality and investigation activities supporting our Mission to enable customers to make the world healthier cleaner and safer.
Day in the Life
Ensure compliance with cGMP ISO 9001 and applicable global regulatory requirements (FDA EMA etc.) serving as a QA SME
Independently lead QA review and approval of qualification and validation protocols (IQ/OQ/PQ) prior to execution ensuring risk-based compliant and inspection-ready documentation
Provide final QA assessment and disposition of executed qualification/validation reports including evaluation of deviations data integrity and adherence to acceptance criteria
Maintain and continuously improve Quality Management Systems (QMS) driving consistency and harmonization across processes
Lead complex deviation investigations ensuring robust root cause analysis effective CAPAs and reduction of recurring events
Own change control quality oversight including risk assessments (e.g. FMEA) and evaluation of impact to validated systems and processes
Lead supplier quality activities including vendor complaint investigations SCAR initiation review and effectiveness verification
Serve as a primary QA representative during internal audits customer audits and regulatory inspections defending quality systems and decisions
Develop and maintain process maps (e.g. SIPOC swimlane diagrams) to identify risks inefficiencies and drive continuous improvement
Apply project management principles to lead quality and validation deliverables including planning prioritization timeline tracking and cross-functional coordination
Partner cross-functionally to resolve systemic quality issues and influence technical and operational decision-making
Support validation and qualification lifecycle activities in alignment with ISPE principles providing QA oversight and guidance
Utilize quality metrics and statistical tools to monitor performance identify trends and proactively mitigate risks
Communicate effectively with internal stakeholders customers and regulatory bodies including escalation of quality risks and recommendations
Keys to Success
Education
Advanced degree with 3 years of relevant experience or
Bachelors degree with 5 years of relevant experience
Engineering Life Sciences Chemistry or a related technical discipline (required)
Experience
Significant experience in quality assurance within a regulated industry (pharmaceutical medical device or biotech)
Demonstrated experience independently reviewing and approving qualification/validation protocols and reports (IQ/OQ/PQ)
Strong experience with:
Deviation management root cause analysis and CAPA effectiveness
Change control and risk management (FMEA)
Document control systems and audit readiness
Experience with supplier quality management including vendor complaints and SCAR processes
Experience developing or utilizing process mapping tools (e.g. flowcharts SIPOC value stream mapping)
Demonstrated application of project management fundamentals in a regulated environment
Experience supporting and interfacing with regulatory inspections and customer audits
ASQ certifications (CQE CQA) strongly preferred
Knowledge Skills Abilities
Knowledge
Deep understanding of cGMP ISO standards and global regulatory expectations
Strong knowledge of qualification/validation lifecycle (IQ/OQ/PQ) and ISPE principles
Knowledge of supplier quality systems and SCAR processes
Familiarity with process improvement methodologies (Lean/Six Sigma concepts preferred)
Working knowledge of statistical analysis and quality tools
Skills
Advanced problem-solving and root cause analysis capabilities
Strong project management fundamentals including prioritization timeline management and cross-functional coordination
Advanced technical writing and critical review of validation and quality documentation
Proficiency with quality management systems and MS Office
Excellent verbal and written communication skills
Ability to influence and drive quality decisions across functions
Abilities
Ability to work independently with minimal oversight as a QA decision-maker
Ability to balance compliance requirements with business needs using a risk-based approach
High attention to detail while maintaining a broader systems-level 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 available
Additional Requirements
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
About Company
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