Qualifications:
B.S. degree in analytical chemistry with 5+ years of analytical chemistry work experience, preferably including work in a GLP or GMP environment.
Previous experience working with extractables/leachables is also desired.
• General Knowledge and Skills Required: Must be well-organized and detail-oriented Must be proficient with MS Office applications, including Word and Excel Must be able to multitask and operate effectively within a diverse work environment.
• Must be team oriented and have strong interpersonal skills.
• Must have excellent written and verbal communication skills
Responsibilities:
Will be responsible for analytical chemistry testing on medical devices and materials in an ISO 17025 certified corporate lab that performs biocompatibility and chemical testing as required by FDA for medical devices and/or therapeutics and in compliance with ISO 10993.
• Conduct analytical chemistry studies utilizing GC/MS, LC/MS and other instrumental methods to characterize and identify unknown extractable and leachable compounds in sample extracts. Performs sample preparation, sample extraction and analyses.
• Operates chemical instrumentation including GC, HPLC/UPLC, ICP, IC, GC/MS, UV/VIS, LC/MS.
• Records raw data according to GLP documentation requirements. Interprets results and prepares technical reports on completed studies.
• Prepares chemical reagents and solutions needed for testing.
• Maintains a safe chemical laboratory environment.
B.S. degree in analytical chemistry with 5+ years of analytical chemistry work experience, preferably including work in a GLP or GMP environment.
Previous experience working with extractables/leachables is also desired.
• General Knowledge and Skills Required: Must be well-organized and detail-oriented Must be proficient with MS Office applications, including Word and Excel Must be able to multitask and operate effectively within a diverse work environment.
• Must be team oriented and have strong interpersonal skills.
• Must have excellent written and verbal communication skills
Responsibilities:
Will be responsible for analytical chemistry testing on medical devices and materials in an ISO 17025 certified corporate lab that performs biocompatibility and chemical testing as required by FDA for medical devices and/or therapeutics and in compliance with ISO 10993.
• Conduct analytical chemistry studies utilizing GC/MS, LC/MS and other instrumental methods to characterize and identify unknown extractable and leachable compounds in sample extracts. Performs sample preparation, sample extraction and analyses.
• Operates chemical instrumentation including GC, HPLC/UPLC, ICP, IC, GC/MS, UV/VIS, LC/MS.
• Records raw data according to GLP documentation requirements. Interprets results and prepares technical reports on completed studies.
• Prepares chemical reagents and solutions needed for testing.
• Maintains a safe chemical laboratory environment.