QC Scientist I

2 weeks ago

High Point, United States Thermo Fisher Scientific Full time

Work ScheduleStandard (Mon-Fri)Environmental ConditionsAdherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Strong Odors (chemical, lubricants, biological products etc.), Will work with hazardous/toxic materialsJob DescriptionAs 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.Location/Division Specific InformationPosition supports the High Point, NC site and the Drug Product Division (DPD).Discover Impactful Work: Provides moderately sophisticated analyses in a chemistry or microbiological environment within defined procedures and practices. Performs analytical methods for moderately complex testing on raw materials, samples, stability, production intermediates, environmental monitoring, sterility tests, growth promotion, microbial limits tests, and/or and antimicrobial efficiency tests. Supports internal development and/or manufacturing operations. Makes detailed observations and reviews, documents, and communicates test results; recommends solutions.A Day in the Life:
Conducts moderately sophisticated chemical and physical testing of pharmaceutical raw materials, packaging components, finished products, microbiological, and stability samples by internally developed and compendial test methods.
Complete validated test methods for pharmaceutical raw materials and finished products for strength, impurities, identity, and dissolution by HPLC, GC, dissolution, spectroscopy, and traditional quantitative analysis, using HPLC, GC, LC/MS, dissolution, spectroscopy, and/or traditional wet chemical testing.
Recognizes and reports out-of-specification or unexpected results and non-routine analytical and product problems; recommends solutions.
Maintains and troubleshoots analytical instrumentation as needed. Clearly and accurately communicates the results of work by crafting documentation of the testing/analysis and acquired results.
Records and reports results of analysis in accordance with prescribed lab procedures and systems. May get along with clients.
Prepares and assists in filing regulatory documents in support of internal projects.
Provides communications with departments, corporate sites, agencies, and clients.
Writes SOPs and other instructional documents.
Cleans and coordinates work area, instrumentation, and testing materials. Cleans HPLC and dissolution systems after use.
Performs all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety guidelines.
Maintains the vital compliance status required by company and facility standards.

Keys to Success:EducationBachelor's degree in science required, preferably in Chemistry or Biology.
Experience:
2 years' experience performing tests or analyses for pharmaceutical raw materials, finished products, or microbiological samples is preferred.
Experience with common office software and chromatographic data acquisition systems is preferred.

Knowledge, Skills, Abilities:
Knowledgeable of chemistry and analytical instrumental technologies.
Knowledgeable of qualitative and quantitative chemical or microbiological analysis.
Knowledgeable of quality and regulatory requirements in the pharmaceutical industry, including pharmaceutical GMPs and descriptive organic chemistry.
Good problem-solving skills and logical approach to solving scientific problems.
Proficiency with HPLC, GC, LC/MS and Dissolution techniques.
Good interpersonal and communication skills (both oral and written).
Good presentation skills to present information to customers, clients, and other employees.
Ability to read, analyze, and interpret technical procedures and governmental regulations.
Ability to write SOPs, simple protocols, and reports.
Ability to respond to common inquiries or complaints from customers or regulatory agencies.
Ability to apply mathematical operations, to such tasks as determination of test reliability, analysis of variance and correlation techniques.

BenefitsWe offer competitive remuneration, annual incentive plan bonus scheme, healthcare, and a range of employee benefits Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.

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