QC & Stability Associate
Do you have experience with Validation or Technology Transfer?
Then we are looking for you!
You will be responsible for:
- for supporting the management of Contract Laboratory Organizations (CLOs) for release and stability of drug substance, drug products and diluent testing.
- Coordinate sample shipment, deviations, change controls, CAPAs, method improvements and gap assessments.
- Contribute to the operation of Stability and Quality release testing programs across a multiproduct portfolio, managing timelines to meet corporate goals.
- Execute reagent requests from testing labs (including in-country testing, method transfers) and arrange internally shipment (many countries require special documents)
- Generate release Certificate of analysis from external testing results, assuring compliance to internal specifications.
- Originate ICH compliant stability protocols and reports, coordinate, review, trend, and report stability test data for commercial and clinical drug product
- Contribute to the preparation and review of CMC stability sections for clinical regulatory filings, MAA, and BLA;
- Contribute to stability and quality sections of Annual Product Review
- Collaborate with Quality, internal functional areas, and CLOs to generate, review and approve documentation, including: SOPs, analytical test methods, change controls, deviations, CAPAs and OOS/OOT investigation reports
- Complete sample submission forms; Track sample testing status; enter results into LIMS as needed; and Compile and generate stability data tables and reports for commercial and clinical products for annual product reviews
- Coordinate with CLOs to forecast testing workload at Contract Laboratory Organization (CLO) and works to level load activities at different QC testing sites, as applicable
- Provide inventory, forecasts demand (quantity) and implements assay controls, critical reagents and reference standards at testing sites
- Contribute to maintenance of a list of approved test sites per product, methods performed/site, regulatory approvals per testing site
- Maintain department and project metrics, as appropriate.
- Analytical background
- Experience in Validation of Analytical methods
- Experience with Technology Transfers is a plus
- 4 - 5 years experience within QC (labo practical or method)
- Statistical background is a plus to understand the proces
- Knowledge ENG