Using good GMP practices, is responsible for timely and accurate inspection and testing of incoming chemicals and analysis of in-process product components prior to the release to manufacturing, ensuring compliance with internal specifications. This position must prioritize to ensure schedule is met. Identifies and documents nonconforming materials and maintains trending of data. Provides technical writing skills as needed. In addition, position is responsible to ensure proper documentation according to cGMP's and current procedures. Performs all duties using safety conscious practices.
Inspects and tests incoming chemicals and in-process product components using analytical analysis and instrumentation (HPLC, UPLC, MS, LC/MS, UV-Vis, etc.).
Supports and executes protocols for analytical test methods and the ability to aid in the transfer of methods to Quality Control.
Identifies non-conforming material and documents conditions in Trackwise deviation system. Maintains / updates the material status of quarantined and non-conforming materials in the ERP/FTPS database.
Support product and process improvement, and engages in special projects as needed in QC and other areas.
Provides technical writing as needed; maintains trending and interpretation of KPI and other data as needed.
Updates procedures and/or specifications in the Document Control System; Performs Verification / Validations of scientific methods, systems, or equipment.
Manages and executes MT (micro-use) preparations and scheduling activities for MT tests.
KNOWLEDGE, EXPERIENCE & SKILLS
Requires a 4-year degree in chemistry, biology or related scientific field.
Requires a minimum of 3 years related experience with proficiency in the use of analytical instrumentation.
Experience in a cGMP / FDA regulated environment is highly preferred.
Requires strong computer skills including Microsoft Office Package (Excel, Word, etc.).
Must possess strong mathematical and analytical skills.
Must be able to demonstrate flexibility in responding to unexpected demands. Must also be able to work in team environment, building effective working relationships.
bioMérieux is an Equal Opportunity, Affirmative Action Employer. M/F/Vet/Disability/Sexual Orientation/Gender Identity/ GINA