– Quality assurance duties relating to studies performed under GLP/GMP/CLIA compliance.
– Participates in the development, implementation, and maintenance of quality systems per GLP, GMP and CLIA regulations.
– Reviews quality related documents, including but not limited to: study protocols, study reports, OOS investigations, validation reports, and other relevant documents as needed.
– Develops and reviews controlled documents and procedures pertinent to quality assurance and operations activities.
– Works cross functionally in identifying and resolving quality issues as they present themselves; Exercises judgment within defined procedures and practices to determine appropriate action.
– Supports the preparation and coordination of inspections by regulatory authorities and clients.
– Assists with the conduct of quality audits both internally and externally per site SOPs and Quality Plan.
– Trains employees on revisions of procedures and the implementation of new procedures.
Job Qualifications:
– Bachelor’s degree or equivalent in a basic science field; with 3+ year’s related experience and/or training; or equivalent combination of education and experience. Focus should be in Hematology (Scientist or Med Tech) and all the other specialties.
– Knowledge and understanding of validation concepts.
– Familiarity with FDA (GLP/GCP/GMP), CLIA, and international regulations (OECD and ICH).
– Previous pharmaceutical, biotechnology, or clinical diagnostic industry experience in QA or regulatory compliance and experience with genetic test methodologies.
– Experience in a GLP, GMP, or CLIA environment.
– Excellent organizational, analytical, planning, and computer skills. Effective verbal and written communication skills.
– Comfortable in a rapidly changing environment. Self-motivated; ability to work independently and work as constructive team member.
– Familiarity with LIMS system and laboratory databases.
– Detail oriented, multi-tasking, with an emphasis successful data delivery.
– A drive to build on current knowledge and experience. Ability to analyze and recommend enhancements to processes, procedures and systems.
– Excellent Communication/Writing skills, experience in regulated manufacturing environment (Diagnostic/Lab).
