Engineer/Scientist I, QC

Thermo Fisher Scientific•Grand Island, NY

2d•Onsite

About The Position

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. The Thermo Fisher Scientific BioProduction division, located at 3175 Staley Road Grand Island NY 14072, supports developers and manufacturers of biological-based therapeutics and vaccines with a portfolio of premium cell culture media and buffers as well as on site custom services dedicated to upstream cell culture, downstream purification, analytics for detection and quantitation of process/product impurities, and a catalog of single-use solutions spanning the biologics workflow. We need a self starting individual with excellent communication and laboratory skills to complete planned and detailed activities within a quality system to ensure product, process, system, or equipment quality requirements are met.

Requirements

BS degree in Chemistry, Biology, or other Sciences.
Functional knowledge of laboratory equipment and techniques such as wet chemistry techniques, autotitrators, polarimetry, Refractive index, UV-Vis, FTIR, Moisture determination, TLC, GC and HPLC.
Strong organizational skills and the ability to work independently.
Ability to work in a high-paced team environment, prioritize work accordingly.
General digital literacy, specifically in Microsoft office programs.

Nice To Haves

Preferred BS Degree in Chemistry with 1-2 years of lab experience.
5 years of experience in a Chemistry lab/cGMP environment/QC or QA related field
Experience with method verifications and validations in a cGMP QC environment.

Responsibilities

Perform a large variety of routine and complex Quantitative and Qualitative procedures in the analysis of raw materials for cell culture media by various testing techniques including but not limited to FTIR, UV-Vis, purity and water determination by auto titrator, Polarimetry, GC and HPLC.
Follow and adhere to GLPs, cGMPs, SOPs and all safety regulations as they apply to the laboratory and work areas.
Serve as a subject matter expert for testing methodologies, providing technical expertise for raw material release decisions, and serving as a key point of contact for internal site teams and off-site testing partners.
Execute lot management activities, including logging, review, and documentation in LIMS and other systems.
Provide technical expertise and support for raw material testing, evaluation, and release decisions.
Perform and/or delegate wet chemical analyses using internal methods and compendial methodologies (USP, EP, ACS, etc.).
Operate and oversee use of laboratory instrumentation, including FTIR, UV-Vis spectrophotometer, polarimeter, pH meter, autotitrator, HPLC, GC, filtration equipment, and endotoxin detection systems.
Support internal method and instrument validations.
Utilize computer-based tools such as Sample Manager (LIMS), Smartsheet, and Microsoft Office (Outlook, Excel, Word).
Support training and development of QC technicians.
Drive investigations related to testing issues and deviations.
Support updates and continuous improvement of testing procedures and laboratory processes.
Provide guidance to supervision on factors that may impact data quality.
Recommend corrective and preventive actions (CAPA) as needed.
Foster a positive laboratory culture by supporting team engagement, motivation, and morale.
Demonstrate sound judgment, tact, and diplomacy when interacting with internal and external customers, including document requests and audits.
Perform additional laboratory functions as assigned.

Benefits

Competitive Pay
Performance Related Bonus where eligible
Annual merit performance-based increase
Medical benefits
Paid Time Off/Annual Leave
Employee Referral Bonus
Career Advancement Opportunities
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