Job Overview
LSC has a unique opportunity for a Sr QA Compliance Specialist to join a leading biopharmaceutical company dedicated to delivering innovative medicines.
The ideal candidate will have 3+ years of experience in Quality Assurance within a biotech manufacturing setting and be ready for a new challenge.
About the Role
* Document Control: Preparation, review, and approval of Material Qualification Documentation.
* QA Disposition: Raw materials, level 1 & level 2 consumables.
* Procedure Authoring: Writing, reviewing, and approving QA-related procedures.
* Biologics Manufacture: Review, assessment, and approval activities for Change controls, Deviations/Investigations, Supplier Investigations, CAPAs, Supplier Change Notifications (SCN), Other associated documentation.
As a core team member of the QA Compliance Materials Management team, you will engage in other support activities as required.
Key Requirements
* Education: BSc in Science or related discipline with a minimum of 3 years' QA or related experience in a Biologics or Pharmaceutical environment.
* cGMP Knowledge: A clear understanding of cGMP requirements for manufacturing and/or systems and compliance.
* MATERIAL QUALIFICATION & SAP: Knowledge would be a distinct advantage.
You must be able to work on your own initiative, in addition to working as part of a team. You will also need to work across a team matrix to meet accelerated timelines.