QC Scientist I

Job Description

Job Summary:

• The Quality Control Scientist I performs routine analyses and documentation of any of the following In-Process and Finished Product samples for pharmaceutical batch Release, Stability samples or Projects within the QC 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.

Duties & Responsibilities:

• Conducts routine chemical testing of finished products, and stability samples by internally developed and compendial test methods.
• Performs validated test methods for pharmaceutical finished products for strength, impurities, identity, and characteristics by using HPLC, dissolution and wet chemistry techniques.
• Recognizes and reports out-of-specification or unexpected results and non-routine analytical and product problems efficiently.
• Performs daily instrument calibrations/verifications as required.
• 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.

Required Education & Experience:

• Bachelor’s degree, or greater, in physical science, preferably in Chemistry.
• 1-2 years of experience performing chemical tests with chromatographic technique (HPLC or GC).
• Working knowledge of HPLC is required as well as use of the instrumentation.
• Equivalent combinations of education, training, & meaningful work experience may be considered.

Knowledge Skills & Abilities:

• 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 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).