Lead QA Technician

Thermo Fisher Scientific; Bohemia (NY); On-site; USD 60,000 - 80,000; Full time

Job summary

A leading company in pharmaceutical manufacturing is seeking a Lead QA Technician to ensure compliance with Good Manufacturing Practices and Quality Management Systems. The role involves detailed batch record reviews, generating SOPs, and training new associates. Candidates should possess a relevant degree and experience in quality assurance, along with strong analytical and leadership skills.

Benefits

Health plans

PTO

Holidays

Parental leave

Insurance

401(k)

ESPP

Qualifications

• 3+ years' experience in Quality or 5+ years with Associate degree.
• Understanding of QA processes including Internal Audits and Change Control.
• Knowledge of industry standards (ISO, Six Sigma).

Responsibilities

• Conduct detailed batch record reviews daily.
• Generate SOPs and checklists supporting company goals.
• Train new associates and lead tier meetings.

Skills

Analytical

Detail-oriented

Problem-solving

Strong communication

Leadership ability

Time management

Critical thinking

Multitasking

Adaptability

Teamwork

Education

Bachelor’s degree in life science, computer science, engineering, or business admin

Associate degree with 5+ years’ experience

Tools

QA tools

Job description

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Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office

Work Schedule

Second Shift (Afternoons)

Shift schedule: 2nd shift, 2:00 PM - 10:30 PM

What will you do?

• Demonstrate and drive the Thermo Fisher values – Integrity, Intensity, Involvement, and Innovation (The Four I’s).
• Apply current Good Manufacturing Principles and Quality Management Systems (QMS) in all responsibilities.
• Create, monitor, and review logbooks for completeness, review, and accuracy annually.
• Generate SOPs, Work Instructions, Master Forms, checklists supporting company goals.
• Continuously improve processes for efficiency and control aligned with Fisher’s PPI processes.
• Cultivate collaboration within the organization and with customers.
• Train new associates.
• Perform detailed batch record reviews daily.
• Conduct pack-out operations accurately according to customer profiles.
• Perform weekly Gemba walks to observe and improve processes.
• Run metrics and report batch record errors monthly.
• Review and sign off on batch record dispositions.
• Ensure adherence to GDP and DI standards.
• Inspect in-process materials for shipping.
• Lead tier meetings as requested.
• Review procedures and reports periodically.
• Provide feedback to quality management for continuous improvement.
• Collaborate with other departments to resolve issues for final release.
• Assist with all quality operation tasks as assigned.

How will you get here?

• Bachelor’s degree in life science, computer science, engineering, or business admin with 3+ years' experience in Quality OR Associate degree with 5+ years’ experience.
• Understanding of QA processes including Internal Audits, Document Control, Deviations, Change Control.
• Analytical, detail-oriented, problem-solving, and strong communication skills.
• Leadership ability, technical proficiency with QA tools, knowledge of industry standards (ISO, Six Sigma).
• Time management, critical thinking, multitasking, adaptability, and teamwork skills.

Preferred Skills

• Any Quality-related certification.

Compensation & Benefits

Hourly pay: $25.60–$38.40 (NY-based). Potential for annual bonus. Total Rewards include health plans, PTO, holidays, parental leave, insurance, 401(k), ESPP, and more. For details, visit Total Rewards.

Additional Information

• Seniority level: Not Applicable
• Employment type: Full-time
• Job function: Quality Assurance, Product Management, Engineering
• Industries: Pharmaceutical Manufacturing, Biotechnology Research