Scientist

Essential Duties and Responsibilities

• Perform analysis using various techniques including established and experimental test methods.
• Use instrumentation both qualitatively and quantitatively where appropriate.
• Helium Leak, O2/CO2/Moisture-Pressure Headspace, Vacuum Decay, Pressure Decay, Dye Ingress testing, UV experience is a plus.
• Manage projects from protocol to final report.
• Train and certify analysts as appropriate.
• Develop and validate methods.
• Keep current with new analytical technology.
• Possess ability to work independently and as part of a team with self-motivation, adaptability, and a positive attitude.
• Prepare technical reports based on data from multiple analysts utilizing multiple analytical techniques.
• Prepare work instructions, SOPs, and qualification documentation.
• Prepare lab study designs and prepare study plans and protocols.
• Interact with internal and external clients as needed.
• Willingness to learn and apply new analytical techniques.
• Perform lab investigations, OOS, and OOT as required.
• Serve as a role model for positive leadership.
• Meet individual and departmental goals as required.
• Apply required cGMP regulations and internal QA procedures.
• Adhere to established laboratory safety procedures.
• Other responsibilities as assigned, including but not limited to performing testing in a cleanroom.

Education

• Associate's Degree Microbiology or Science related discipline required
• Bachelor's Degree Microbiology or Science related discipline preferred

Work Experience

• BS in Chemistry or related technical degree required
• Minimum 3 Years of experience in a GMP Laboratory Preferred

Knowledge, Skills and Abilities

• cGMP
• ISO and USP/EP compendia
• Strong oral and written communication skills and attention to detail required
• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
• Experience in Helium Leak testing, O2/CO2/Moisture-pressure Headspace analysis, Vacuum Decay, Dye Ingress testing, Method Development and Validation
• Able to comply with the company’s safety policy at all times
• Able to comply with the company’s quality policy at all times