Technical Supervisor​/QA; Part-Time

Responsibilities

• 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.

• Bachelor’s degree or equivalent in a basic science field; with 3+ years 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).