Chemical Analysis Professional
We are seeking a highly skilled Chemical Analysis Professional to join our team in a 12-month contract position. The successful candidate will be responsible for working on-site three days a week and remotely two days a week.
About the Role:
* Isolate particles from sterile biologics and utilize advanced techniques such as FTIR, scanning electron microscopy, and Raman spectroscopy to investigate their origin.
* Provide analytical chemistry services and support to the organization, interacting with various departments as needed.
* Maintain, update, and issue chemical methods, specifications, and standard operating procedures (SOPs) in compliance with regulatory requirements.
* Assist with training analysts in areas of expertise and knowledge, and provide updates on new methods, SOPs, and procedures.
* Trend results, record Certificates of Analysis (COA) where required, and complete out-of-specification (OOS) investigations on a timely basis.
* Communicate with the Quality Control Team Leader on potential problems and highlight improvements where possible.
* Ensure all quality documentation and records are complete and current.
* Ensure Quality Control laboratories meet current Good Laboratory Practice (cGLP) requirements.
* Verify that critical chemical testing and related equipment meets current validation requirements (IQ, OQ, PQ).
* Audit and review chemistry test results daily to ensure compliance with cGLP.
* Check laboratory notebooks and analytical reports for accuracy.
Requirements:
* 4 years' experience in the Medical Device Industry.
* Minimum of a primary degree in an Engineering or Technical Discipline.
* Experience in process characterization, validation, and statistical methods.
* Meticulous attention to detail with a methodical and analytical approach to problem-solving.
About You:
* You have a strong understanding of analytical chemistry principles and practices.
* You possess excellent communication and interpersonal skills.
* You are able to work effectively in a team environment.
* You have a high level of organizational and time management skills.