This position will work in the GMP compliant QC Laboratories to qualify and conduct chemistry-based assays that support quality control of bio-pharmaceutical products being developed and manufactured. Supports analytical test method validation and transfer activities at and between external sites for qPCR and ddPCR
Independently applies scientific judgment and contribute to milestones related to specific projects.
Represents QC business processes and needs within the department and at cross functional forums.
Maintains cGMP compliance within their laboratories & generates, revises, and/or approves SOP or test methods.
Ensures that all work is in compliance with the required regulatory standards, conforms to company policies and standard operating procedures (SOPs).
Initiates and owns deviations, CAPAs and change controls within the electronic Quality Management System.
Supports regulatory inspections and audits
Requires BS degree in Chemistry, Biology or other related scientific discipline.
Applied knowledge and in-depth understanding of GMP Quality Control systems
At least 5-7 years’ experience with relevant laboratory experience in a regulated manufacturing or QC laboratory environment.
It is preferred the candidate have analytical experience with PCR, SDS Page and USP Compendia methods.
Ability to prioritize objectives from multiple projects, adhere to scheduled timelines while maintaining flexibility and attention to detail
Completes tasks where judgment is required in resolving problems and recommendations.
Experience with electronic systems such as LIMS, Trackwise, etc., is an advantage.