QC Scientist I

Job Description

Job Summary:

• The QC Scientist I performs routine analyses and documentation of any of the following:
• Raw Materials, In-Process samples, Calibrations, or projects within the QC Chemistry Laboratory, in a manner consistent with established standards.
• Supports internal development and/or manufacturing operations.
• Makes detailed observations and reviews, documents, and communicates test results.

Duties and Responsibilities:

• Conducts routine chemical and physical testing of raw materials by internally developed and compendial test methods.
• Executes validated test methods for pharmaceutical raw materials for strength, impurities, identity, and characteristics by utilizing HPLC, GC, 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 accurate documentation of the testing/analysis and acquired results.
• Records and reports results of analysis in accordance with prescribed lab procedures and systems.
• Prepares test solutions including medias and mobile phases.
• Cleans and maintains work area and instrumentation.
• 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.

Education:

• Bachelor’s degree in physical science, preferably in Chemistry is a must.

Experience:

• Typically requires no previous related experience.
• Experience performing chemical tests with chromatographic, spectroscopic, other analytical techniques or Compendial testing highly preferred.

Equivalency:

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

Knowledge, Skills, and Abilities:

• Good knowledge and understanding of basic instrumental technologies and qualitative and quantitative chemical analyses.
• Awareness of quality and regulatory requirements in the pharmaceutical industry.
• Good problem-solving skills and logical approach to solving scientific problems.
• Follow all company policies, SOPs, cGMPs, work instructions, methods and analyst’s guidelines.
• Demonstrates efficiency by multitasking and scheduling time to meet required workload.
• Actively seek additional assignments when testing in primary area of responsibility is completed.
• Takes initiative and independently pursues training and/or learning opportunities to improve personal skills and share skills with other team members.
• Proven 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.
• Ability to work in a fast-paced environment.

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.