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Thermo Fisher Scientific QC Scientist in Florence, South Carolina

Job Title: QC Scientist

Business Title: QC Scientist

Job Code: OPS.QCNE.P04

Band: 4

Effective Date:

Last Modification Date:

Summary:

Under the direction of the Laboratory Services Supervisor, the Chemist (I) is responsible for performing routine laboratory procedures in a quality control laboratory. Duties are performed under general supervision. Familiar with basic laboratory equipment and techniques. Responsibilities are focused on less complex testing and support functions. Supports internal development and/or manufacturing operations. Makes detailed observations and reviews, documents, and communicates test results.

Essential Functions:

I. Conducts routine chemical and physical testing of pharmaceutical raw materials, packaging components, finished products, microbiological, and stability samples by internally developed and compendia! test methods.

Executes 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, utilizing HPLC, GC, LC/MS, dissolution, spectroscopy, and/or traditional wet chemicaltesting.

Recognizes and reports out-of-specification or unexpected results and non-routine analytical and product problems. Sets up and dismantles instruments and apparatus. Prepares solutions, suspensions and media to perform essential laboratory procedures. Makes and records observations, performs calculations, collects and may assist in preparing data for evaluation. Keeps supervisor informed of work status. Prioritizes workload and meets scheduled timelines. Informs supervisor of equipment and supply needs required to avoid delays in testing. Reports results of assignments and maintains and performs related record keeping in compliance with approved regulatory policies and standards to meet quality and accuracy requirements. Follows and complies with all appropriate operations and testing procedures, GMPs and safety and health requirements as applicable. Demonstrates good housekeeping practices to minimize analytical mix ups, potential laboratory contamination

and safety hazards. Understanding and handling of hazardous materials and waste using proper and safe techniques.

Performs daily instrument calibrations/ verifications as required. Clearly and accurately communicates the results of work by creating documentation of the testing/analysis and obtained results. Records and reports results of analysis in accordance with prescribed lab procedures and systems. Assists in preparing regulatory documents and other communications with outside agencies, clients, and/or colleagues from other corporate sites. Cleans and organizes work area, instrumentation, and testing materials. Performs all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety guidelines. Maintains the necessary compliance status required by company and facility standards. Periodically performs duties of a higher position for the purpose of training and development. Other duties may be assigned as required.

Education:

Bachelor's degree in physical science, preferably in Chemistry or Biology.

Equivalency:

Equivalent combinations of education, training, and relevant work experience may be considered.

Competencies/ Skills:

  • Good knowledge and understanding of basic instrumental technologies. Knowledge of qualitative and quantitative chemical or microbiological analysis.

  • Awareness of quality and regulatory requirements in the pharmaceutical industry.

  • Good problem-solving skills and logical approach to solving scientific problems.

  • Demonstrable interpersonal and communication skills (both oral and written).

  • Ability to read and interpret technical procedures and governmental regulations.

  • Ability to apply mathematical operations to such tasks as determination of test reliability, analysis of variance, and correlation techniques.

Expected high performance behaviors:

  • Exhibit positive attitude regarding work and responsibilities

  • Ability to work collaboratively within teams

  • Ability to work overtime (expect to work extra hours if necessary).

  • Ability to maintain effectiveness during major changes in work tasks or the work environment; adjusting

effectively to within new work structures, processes, requirements or cultures

  • Continuously look for ways to do things faster and better, while maintaining high quality standards

  • Is creative and intellectually curious; tries different and novel ways to solve obstacles

Physical Requirements:

Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, cmTy, move) of light to medium weights of 10-35 pound pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time. Safety glasses, safety shoes, lab coat, latex or similar gloves, safety apron, organic respirator occasionally.

Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.

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