Job Title: Chemical Expert
We are seeking a highly skilled and experienced Chemical Expert to join our team in providing analytical chemistry services.
Key Responsibilities:
* Isolate particles from sterile biologics and investigate their origin using techniques such as FTIR, scanning electron microscopy, and RAMAN spectroscopy.
* Provide analytical chemistry services and support to the site, including close contact with Quality Assurance, Production, Engineering, and Planners.
* Maintain, update, and issue chemical methods, specifications, and SOPs in compliance with pharmacopoeial and regulatory requirements.
* Assist with training of analysts in areas of expertise and knowledge, as well as new methods, SOPs, and updates.
* Trend results, record on COAs where required, and complete OOS investigations on a timely basis.
* Update the QC Team Leader on potential problems and highlight improvements where possible.
* Ensure all quality documentation and records are complete and current.
* Ensure QC laboratories meet current Good Laboratory Practice (cGLP) requirements.
* Ensure relevant procedures are correctly defined and followed.
* Audit and review chemistry test results on a daily basis and ensure compliance with cGLP.
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.