Quality Engineer - Clinical Labeling [Remote]

JOB DESCRIPTION

Work Schedule

Environmental Conditions

Job 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 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 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

• Bachelor’s 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

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

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