Quality Control (QC) Scientist I

Quality Control (QC) Scientist I

Location & Shift

Location: Grand Island, NY
Shift: First Shift (Monday – Friday), 8:00 AM – 4:30 PM
Some schedule flexibility may be required during training or to support production needs.

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

• Cold rooms/freezers: -22°F / -6°C
• Laboratory and manufacturing support environment; office setting
• Some degree of PPE required (e.g., safety glasses, gowning, gloves, lab coat, hearing protection)
• Strong odors (e.g., chemical, lubricants, biological products)
• Work with hazardous/toxic materials

Job Description

As a Scientist I on the Quality Control team, you will help ensure the quality of raw materials used to manufacture cell culture media that support life-saving biologics and vaccines. Your work will support manufacturing operations, regulatory compliance, and customer confidence, while contributing to continuous improvement initiatives across the laboratory.

How You’ll Make an Impact

In this role, you will perform analytical testing and quality evaluations to ensure raw materials meet the highest quality standards for use in cell culture media manufacturing.

• Perform routine and complex qualitative and quantitative analyses of raw materials used in cell culture media production.
• Use analytical techniques including FTIR, UV-Vis spectroscopy, HPLC, GC, polarimetry, moisture determination by autotitrator, and other wet chemistry methods.
• Follow and maintain compliance with GLP, current cGMP, SOPs, and all laboratory safety requirements.
• Serve as a subject matter expert for testing methodologies and provide technical support for raw material release decisions.
• Collaborate with internal site teams and external testing partners to ensure accurate and timely analytical results.

Additional Responsibilities

• Execute lot management activities, including sample logging, review, documentation, and tracking using LIMS and related systems.
• Provide technical expertise and support for raw material testing, evaluation, and release decisions.
• Perform and/or coordinate wet chemistry analyses using internal methods and compendial methodologies, including USP, EP, ACS, and related standards.
• Operate and maintain analytical instrumentation, including HPLC, GC, FTIR, UV-Vis, polarimetry, autotitrators, and other laboratory equipment.
• Support laboratory method verifications, method validations, and instrument qualification activities.
• Use computer systems including Sample Manager (LIMS), Smartsheet, Microsoft Excel, Outlook, and Word.
• Support training and technical development of Quality Control Technicians.
• Lead or support investigations related to laboratory testing issues, deviations, and out-of-specification events.
• Assist with updates to laboratory procedures and drive continuous improvement initiatives.
• Provide guidance to laboratory leadership regarding factors that may affect analytical data quality.
• Recommend and support Corrective and Preventive Actions (CAPA) when appropriate.
• Foster a positive, collaborative laboratory culture emphasizing teamwork, engagement, and scientific excellence.
• Demonstrate professionalism, sound judgment, and effective communication with internal customers, auditors, and external partners.
• Perform additional laboratory responsibilities as assigned.

Minimum Qualifications

Education Required

• Bachelor’s degree in Chemistry, Biology, or another scientific discipline

Experience Required

• 2+ years of laboratory experience in a cGMP environment or Quality Control/Quality Assurance laboratory

Knowledge, Skills, and Abilities

• Experience with laboratory instrumentation and analytical techniques such as wet chemistry, HPLC, GC, FTIR, UV-Vis, polarimetry, refractive index, moisture determination, Thin Layer Chromatography (TLC), autotitrators, etc.
• Strong organizational and time management skills
• Ability to work independently while managing multiple priorities in a fast-paced laboratory environment
• Excellent written and verbal communication skills
• Strong attention to detail and documentation practices
• Proficiency with Microsoft Office applications
• Experience performing method verifications and method validations in a cGMP Quality Control laboratory preferred

Physical Requirements / Work Environment

This position requires work in a laboratory and manufacturing support environment.

Responsibilities include:

• Wearing appropriate Personal Protective Equipment (PPE), including safety glasses, gloves, lab coat, gowning, and hearing protection as required
• Lifting up to 40 pounds without assistance
• Working in compliance with all GMP and safety standards
• Occasional work in cold rooms or freezers (-22°F / -6°C)
• Entering warehouse areas to perform inspections
• Working safely with hazardous and toxic laboratory materials

Additional Information

• This position is not eligible for relocation assistance.
• This position is not eligible for employment visa sponsorship, now or in the future.
• Employment is contingent upon the successful completion of a pre-employment background check and drug screening.

What We Offer

Thermo Fisher Scientific is committed to supporting your professional growth and personal well-being through competitive compensation and comprehensive benefits.

Our offerings include:

• Competitive base pay
• Annual performance-based bonus (where eligible)
• Annual merit-based salary increases
• Comprehensive medical benefits
• Paid Time Off (PTO) and annual leave
• Employee Referral Bonus Program
• Career advancement and internal mobility opportunities
• Access to learning and development resources within a global organization

Compensation and Benefits

The salary range estimated for this position based in New York is $50,000.00–$72,000.00.

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 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), offering eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits, visit: https://jobs.thermofisher.com/global/en/total-rewards