Scientist 1

Job Description

Job Summary:

• Performs validated chemical & physical testing on in-process, finished product, and stability samples to ensure compliance with quality and regulatory standards
• Conducts analytical testing using techniques such as dissolution, HPLC, GC, and spectroscopy
• Recognizes and reports out-of-specification or unexpected results and non-routine analytical and product problems efficiently
• Performs daily instrument calibrations/verifications as required
• Collaborates with others to troubleshoot and resolve quality issues
• Maintains accurate documentation of test results and analysis
• Performs all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety guidelines

PROFICIENCIES:

• Experience with Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).  Experience with HPLC and dissolution are preferred. Effective written and interpersonal skills with the ability to interact with Auditors if there is a need. Strong proficiency in Microsoft Office Suite (Word, Excel, and Power Point). Ability to multitask by working on multiple projects simultaneously, and able to adapt and change priorities when business needs demand a shift in priority. Ability to work weekends when needed based on business needs.

Required Skills:  

• Typically requires a minimum of 2 years of experience performing tests or analyses for pharmaceutical raw materials or finished products samples. Experience with common office software.

Requirements:

• Conducts analytical testing using techniques such as dissolution, HPLC, GC, and spectroscopy
• Proven experience in a QC laboratory setting inclusive of chromatographic, spectroscopic, or other analytical technique is preferred
• Strong knowledge of analytical techniques and instrumentation
• Exceptional attention to detail and ability to perform flawless work
• Good problem-solving skills and logical approach to solving scientific problems
• Strong motivation to excel and a desire for continuous growth
• Ability to determine root causes of quality issues and successfully implement corrective actions

PHYSICAL REQUIREMENTS:

• Position requires physical coordination for office tasks, including sitting, standing, walking, lifting 10-35 pounds, typing, and using equipment.

Preferred Skills:

• Dissolution
• HPLC

Degree/Certifications:

• Bachelor’s degree in chemistry, Biology, or a related field (FOCUS IS ON CHEM)

Top Skills:

• HPLC (Empower)
• LIMS system Use
• GXP Documentation