Quality Control (QC) Scientist I

Work Schedule

Environmental Conditions

Job Description

Quality Control (QC) Scientist I

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.)

Join a Team Thats Improving Lives Around the World

At Thermo Fisher Scientific youll discover meaningful work that makes a positive impact on a global scale. Join more than 100000 colleagues who bring our Mission to life every dayenabling our customers to make the world healthier cleaner and safer.

As a Scientist I on our Quality Control team youll play a vital role in ensuring the quality of raw materials used to manufacture cell culture media that support life-saving biologics and vaccines. Whether youre looking to deepen your analytical chemistry expertise expand your cGMP experience or build a long-term career with a global leader in life sciences Thermo Fisher offers the opportunity to grow while making a real difference.

Why Youll Love Working Here

Located in Grand Island New York our BioProduction campus combines cutting-edge science with a collaborative team environment and opportunities for career growth. Our division supports developers and manufacturers of biological therapeutics and vaccines through a comprehensive portfolio of premium cell culture media buffers custom services analytical testing and single-use solutions across the biologics workflow.

How Youll Make an Impact

As a Quality Control Scientist I youll perform analytical testing and quality evaluations that ensure raw materials meet the highest quality standards for use in cell culture media manufacturing. Your work will directly support manufacturing operations regulatory compliance and customer confidence while contributing to continuous improvement initiatives across the laboratory.

In this role you will:

• Perform routine and complex qualitative and quantitative analyses of raw materials used in cell culture media production.

• Utilize a variety of analytical techniques including FTIR UV-Vis spectroscopy HPLC GC polarimetry moisture determination by autotitrator and other wet chemistry methods.

• Follow and maintain compliance with Good Laboratory Practices (GLP) current Good Manufacturing Practices (cGMP) Standard Operating Procedures (SOPs) and all laboratory safety requirements.

• Serve as a subject matter expert for testing methodologies while providing technical support for raw material release decisions.

• Collaborate with internal site teams and external testing partners to ensure accurate and timely analytical results.

• 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 used for raw material testing.

• Support laboratory method verifications method validations and instrument qualification activities.

• Utilize computer systems including Sample Manager (LIMS) Smartsheet Microsoft Excel Outlook and Word.

• Support the 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 that emphasizes teamwork engagement and scientific excellence.

• Demonstrate professionalism sound judgment and effective communication when working with internal customers auditors and external partners.

• Perform additional laboratory responsibilities as assigned.

Minimum Qualifications

Education Required:

• Bachelors 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 Good Manufacturing Practice (GMP) and safety standards

• Occasional work in cold rooms or freezers (-22F / -6C)

• 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

Join Thermo Fisher Scientific and become part of a team where your scientific expertise helps advance therapies that improve lives around the world. Together well continue taking science a step beyond.

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

For more information on our benefits please visit: Experience:

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