Job Title:
Chemical Process Specialist
We are seeking a Chemical Process Specialist to join our team. This role involves working in analytical chemistry for pharmaceutical clients.
* You will be responsible for isolating particles from sterile biologics and identifying their origin.
* Provide analytical chemistry services and support to the site, ensuring effective interaction with other departments on matters related to raw materials, intermediates, and finished batches.
* Maintenance and update of chemical methods, specifications, and Standard Operating Procedures (SOPs) are crucial to regulatory compliance.
* You will assist in training analysts in areas of expertise and knowledge and new methods, SOPs, and updates.
* Trend results, record Certificates of Analysis where required, complete Out of Specification investigations on time, and keep QC Team Leaders informed of potential problems and improvements.
* Ensure quality documentation and records are up-to-date and that QC laboratories meet current Good Laboratory Practice (cGLP) requirements.
* Audit and review chemistry test results daily, ensuring compliance with cGLP.
Key Requirements:
* 4 years' experience in the Medical Device Industry.
* Primary degree in an Engineering or Technical Discipline.
* Experience in Process characterization, Validation, and statistical methods.
* Meticulous attention to detail with a methodical approach to problem-solving.