QC Scientist I

Job Description

Job Summary:

• The QC Scientist I performs routine analyses and documentation of any of the following:
• Residual Active Pharmaceutical and Detergent Analysis in support of pharmaceutical manufacturing operations within the QC Analytical Chemistry Laboratory, in a manner consistent with established standards.
• Supports internal development and/or manufacturing operations.
• Makes detailed observations & reviews, documents, and communicates test results.

Crucial Functions:

• Conducts routine chemical testing of residual swab samples by internally developed test methods.
• Performs validated test methods for pharmaceutical residual analysis by using HPLC, Mass Spectrometry, and TOC techniques.
• Recognizes and reports out-of-specification or unexpected results and non-routine analytical and product problems effectively & efficiently.
• Performs daily instrument calibrations/verifications as the need arises.
• Clearly and accurately communicates the results of work by accurate documentation of the testing/analysis & acquired results.
• Records and reports results of analysis in accordance with prescribed lab procedures & systems.
• Prepares test solutions including diluents and mobile phases.
• Cleans and maintains work area & instrumentation.
• Performs all duties in strict compliance with Standard
• Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety guidelines.
• Maintains vital compliance status required by company and facility standards.

Education:

• Bachelor’s degree, or greater, in physical science, preferably in Chemistry.

Experience:

• 1-2 years of experience performing chemical tests with chromatographic technique is preferred.
• Working theoretical knowledge of HPLC and Mass Spectrometry is required as well as practical execution.

Equivalency:

• Equivalent combinations of education, training, & meaningful work experience may be considered.

Proficiencies:

• Good knowledge & understanding of basic instrumental technologies and qualitative & quantitative chemical analyses.
• Awareness of quality & 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 & analyst 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.
• Shown interpersonal and communication skills (both oral & 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.

Use of:

• Safety glasses
• Safety shoes
• Lab coat
• Latex or similar gloves
• Safety apron
• Organic respirator occasionally (i.e. Surge 100)