Position Summary & Responsibilities:
The Associate Quality Assurance Engineer acts as quality oversight to STL site reagents operations. Reviewing and approving the following: change controls, quality events, cause investigations, OOS investigations, in process forms, method validation protocols. Specialty oversight will be related to incoming process chemicals and formulated long term stocks.
- Support teams with a quality voice for continuous improvement efforts.
- Write, review, and/or approve procedures or specifications in the Document Control System.
- Write, review, and/or approve records within the Trackwise Digital quality system.
- Act as Technical SME for the Incoming QC Chemistry team as needed. Provides technical writing support as needed for the compliant completion of documents, reports, and investigations.
- Support quality team (as applicable) for other operations departments to include media preparation, card production, QC microbiology, and incoming materials
- Quality support for incoming chemicals and in-process product components using analytical analysis and instrumentation (HPLC/UPLC, FTIR, UV-Vis, etc.).
- Supports trending and interpretation of KPI and other data as needed.
- Maintains a thorough understanding of all specifications, requirements, and procedures and provides input regarding the continuous improvement of each.
- As applicable, support the validation team in regard to execution of protocols for analytical test methods, validations of process of scientific methods, systems, or equipment.
Education, Skills, & Experience:
- Bachelor's degree in Analytical Chemistry or related field with 3+ years' experience in a CGMP manufacturing or laboratory environment.
- Associate's degree with 5+ years' experience in a cGMP manufacturing or laboratory environment
- High School Diploma with 7+ years' experience in a cGMP manufacturing or laboratory environment.
- Requires a minimum of 3 years related experience with proficiency in the use of analytical instrumentation (HPLC/UPLC, FTIR, UV-Vis, etc.).
- Experience with Pharmacopoeia chapters, monographs and requirements is required.
- Requires strong computer skills including Microsoft Office Package (Access, Excel, Word, etc.).
- Must be able to demonstrate flexibility in responding to unexpected demands. Must also be able to work in team environment, building effective working relationships.
- Requires effective written and oral communication skills.
- Must possess proficient mathematical and analytical chemistry skills.