Job Description
Job Description
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.
Job Functions :
- 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.
Education / Experience :
- 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.
Knowledge / Skills / Abilites :
- 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.
Company Description
Since 2002 Maxonic has been at the forefront of connecting candidate strengths to client challenges. Our award-winning, dedicated team of recruiting professionals specialized in technology, are great listeners and will seek to find a position that meets the long-term career needs of our candidates.
We take pride in the over 5,000 candidates that we have placed, and the repeat business that we earn from our satisfied clients.
Company Description
Since 2002 Maxonic has been at the forefront of connecting candidate strengths to client challenges. Our award-winning, dedicated team of recruiting professionals specialized in technology, are great listeners and will seek to find a position that meets the long-term career needs of our candidates.
We take pride in the over 5,000 candidates that we have placed, and the repeat business that we earn from our satisfied clients.