Clinical and Health
2 weeks ago
Position 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.
- 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 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.
- Bachelor’s degree, or greater, in physical science, preferably in Chemistry.
- 1-2 years of experience performing chemical tests with chromatographic technique is preferred.
- Working theoretical knowledge of HPLC is required as well as practical execution.
- Equivalent combinations of education, training, & meaningful work experience may be considered.
- 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.
- 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 (i.e. Surge 100)
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