QC Scientist I

Job Description

Duties and Responsibilities:

• Completes routine chemical and physical testing of raw materials using internally developed and compendial test methods.
• Implements validated test methods for pharmaceutical raw materials for strength, impurities, identity, and characteristics by applying HPLC, GC, spectroscopy, and/or traditional wet chemical testing.
• Identifies and reports out-of-specification or unexpected results and non-routine analytical and product problems.
• Conducts daily instrument calibrations / verifications as needed.
• Communicates the results of work clearly and accurately through precise documentation of the testing/analysis and acquired results.
• Documents and reports analysis results following prescribed lab procedures and systems.
• Prepares test solutions including medias and mobile phases.
• Maintains cleanliness and upkeep of work area and instrumentation.
• Carries out all responsibilities in strict adherence to Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety guidelines.
• Upholds the necessary compliance standards mandated by company and facility protocols.
• 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.

Business Needs:

• Main business group.
• Reason for new request.
• Sourcing model.
• Training schedule.
• Possibility of conversion.

Requirements:

• Bachelor s degree in physical science, preferably in Chemistry or Biology.
• 0-2 years of experience.
• Prior Lab Experience ( can use College Lab Experience for this)
• Experience performing chemical tests with chromatographic, spectroscopic, other analytical techniques or Compendial testing preferred.

Culture and Expectations:

• Dress Code.
• Site Providing.
• Equipment Requirements.
• Work Environment.
• Team Structure.
• Day to Day.

Physical Requirements:

• Requires physical coordination to move around office, stand, walk, stoop, kneel, crouch; lift 10-35 pounds; grasp, type, use a keyboard, sit, reach, talk, hear.