Through collaboration with QC, Manufacturing, Technical Operation, Validations, Facilities, and other operational departments the QA Compliance Specialist will support continuous improvement and companywide efforts to maintain acceptable levels of compliance with internal procedures, corporate requirements and applicable regulations (i.e. FDA, EMA, etc.). This position will support the maintenance of quality systems for exceptions management, approved supplier program, and key performance indicator/metrics monitoring program.
Part-time -- 20 hours per week, flexible schedule!
LFB USA has an opportunity for a highly motivated, flexible, organized, and detail oriented Contracts Administrator/Paralegal to join our team on a part time basis to serve as a contributor in drafting and negotiating contracts, maintaining a contracts database and providing administrative support on general corporate legal matters.
Through collaboration with Manufacturing, Quality Control, Clinical Affairs, Facilities, and other operationaldepartments, maintains the company's training system, including creation and maintenance of role based curricula, optimization of the competency based on-the-job-training, and authoring/revising associated documentation.
Responsible for supporting the QC function in terms of method validation, transfer of analytical processes to CMOs, writing and reviewing protocols, change controls and SOPs, and assisting with testing for stability, in process and release of samples.