Title:  Associate Scientist

What We Offer

Shift

1st Shift: 8:00 am to 5:00 pm ET

Job Summary

As the Associate Scientist, CCI, you will be responsible for performing testing for both internal and external customers in a cGMP environment.  

Essential Duties and Responsibilities

• • Perform analysis using various techniques including established and experimental test methods, standards and guidance. 
  • Use instrumentation both qualitatively and quantitatively where appropriate.
  • With guidance assist in completing projects from protocol to final report. 
  • Train analysts as appropriate. 
  • Develop and validate methods with guidance.
  • Keep current with new analytical technology.
  • Possess ability to work autonomously and as part of a team.
  • Candidates must possess self-motivation, adaptability, and a positive attitude
  • Assist in the preparation of technical reports.
  • Assist in preparation of work instructions, SOPs, and qualification documentation.
  • Assist in lab study design and preparation in study plans and protocols.
  • Willingness to learn and apply new analytical techniques.
  • With guidance, participate in lab investigations, OOS, and OOT as required.
  • Meet individual and departmental goals as required.
  • Apply required cGMP regulations and internal QA procedures
  • Adhere to established laboratory safety procedures
  • Other duties as assigned.

Education

• Bachelor's Degree in Biology, Chemistry or a relevant scientific field required

Work Experience

• 0 - 3 years of experience required and
• Experience working in a laboratory or cGMP/pharmaceutical environment preferred
• Laboratory Analyst role preferred

Preferred Knowledge, Skills and Abilities

• Support and contribute to Lean Sigma programs and activities towards delivery of the set target
• cGMP
• 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, Headspace analysis, Vacuum Decay, Dye Ingress testing, Method Development and Validation.
• Willingness to learn and apply new analytical techniques
• Proficient in Microsoft Office tools and capable to learn other software programs
• Able to review regulatory code and learn safety standards
• Able to be aware of all relevant standard operating procedures as per Company policy as they are related to the position covered by this Job Description
• Able to comply with the company’s safety and quality policies at all times

Travel Requirements

Physical Requirements

Additional Requirements

• Must be able to stand for long periods of time
• Use hands to finger, handle, feel or operate objects, tools or controls and reach with hands and arms
• Physical ability and willingness to wear proper gowning for work in an ISO 5 compliant particulate cleanroom environment
• Must be able to communicate effectively with written and oral skills, make quick decisions, interpret data, read and write, speak in front of groups, express and exchange ideas, understand direction and adhere to procedures
• Organizational skills will enable planning, prioritization and achievement of goals especially of importance for the successful execution of related activities
• Read and interpret data, information and documents
• Must maintain the ability to work well with others in a variety of situations
• Must be able to follow directions, multi-task, work under time constraints, problem solve, and prioritize
• Ability to make independent and sound judgments
• Observe and interpret situations, analyze and solve problems