Support day-to-day Quality Assurance activities by approved Standard Operating Procedures (SOPs) and Policies for a GMP facility.
Maintain availability of template documents for new starters, internal transfers, and employees changing roles, and update the LMS to reflect the completion of these documents.
Make real-time decisions on process events on the floor based on knowledge of defined SOPs and Policies.
Maintain a good understanding of GMP compliance.
Assist in deviation investigations, change controls, and Corrective and Preventive Action (CAPA) implementation.
Responsible for supporting regulatory inspections and customer audits as required.
Work directly with department points of contact to identify efficient and actionable structure changes to training requirements that can scale to changes in headcount and reporting lines.
Requirements & Skills:
Preferably a BA or BSc or equivalent experience in Life Sciences, IT, or Education.
Extensive experience in using an LMS package, preferably Cornerstone.
Previous experience working within a GMP environment or an equivalent regulated environment.
Well-organized and used to handling large volumes of paper records.
Experience working as an active member of the team, generously sharing information and knowledge with others in the team.
