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Description

QC Scientist I - Chromatography

Summary:

Provides routine analyses in a chemistry laboratory environment by following standard practices. Performs analytical methods as assigned for testing on in-process, finished product, and stability samples. Supports internal development and/or manufacturing operations. Makes detailed observations and reviews, documents, and communicates test results.

Essential Functions:

Conducts routine chemical and physical testing of pharmaceutical finished products and stability samples by internally developed and compendial test methods. Executes validated test methods for pharmaceutical finished products for strength, impurities, identity, and dissolution by HPLC, GC, and spectroscopy, and/or traditional wet chemical testing. Recognizes and reports out-of-specification or unexpected results and non-routine analytical and product problems. 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. Contributes to writing of SOPs if needed. Cleans and organizes 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 necessary compliance status required by company and facility standards.

Education:

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

Experience:

Typically requires 0-2 years of related experience or education. Experience performing chemical tests with chromatographic, spectroscopic, or other analytical technique preferred.

Equivalency:

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

Competencies:

Good knowledge and understanding of basic instrumental technologies. Knowledge of qualitative and quantitative chemical 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.

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, carry, 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.

Additional Details:

• What is the pay rate to the resource: XXX3
• Is this role temp to perm: Yes
• Assignment duration: 12 Months
• Position hours and days: Monday Friday 1^st Shift: 8:00 4:00 with flexibility
• Interview process: MS Teams 1 interview with 2 people.
• Required experience that a candidate must have for consideration:
  • B.S in Chemistry or Science.
  • Prior experience with HPLC or GMP,
  • 0- 2 years, prior pharma is a plus
• Intangible skills: Critical thinking skills, Problem Solving, Ability to change priorities and work at a fast pace.

Disclaimer:

This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.

Nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.

Respirator required