Product Evaluations Technician

Product Evaluations Technician I has the overall responsibility for execution of studies, reporting of study results, and ensuring compliance with applicable standards and company quality systems.

• Ensuring equipment is adequately calibrated, inspected, cleaned, and maintained prior to use in a study.
• Ensuring all reagents and solutions in the laboratory areas are labeled to indicate identity, titer or concentration, storage requirements, and expiration date.
• Ensuring functions performed are clearly understood and conducted in accordance with the approved protocol.
• Ensuring all data generated during the conduct of a laboratory study, except those that are generated by automated data collection systems, are recorded directly, promptly, and legibly in ink and data documentation procedures followed.
• Ensuring all experimental data, including observations of unanticipated responses of the test system are accurately recorded and verified.
• Ensuring all raw data, documentation, protocols, final reports, and specimens (as appropriate) generated as a result of a laboratory study are retained.
• Performing data analysis and creating software scripts and templates to perform data analysis.
• Ensuring unforeseen circumstances that may affect the quality and integrity of the laboratory study are noted when they occur, escalated to appropriate personnel and corrective action is taken and documented.
• Participating in regulatory inspection activities with regulatory agencies, as needed.
• Participating in the Quality Management System including Document Control, Employee Training, Purchasing, Work Order Program, Corrective and Preventive Actions, Controlled Equipment management, Internal Audits, and Record and Data Control.

• High school diploma or general education degree (GED); and minimum of 2 years of technical experience.
• Understanding of quality system requirements including ISO/IEC 17025 and 21 CFR part 58 is required. Experience in 21 CFR Part 820 and Part 11, ISO 13485, and other relevant international standards is highly desirable.
• Must be organized, with analytical and problem‑solving abilities.
• Ability to read and interpret technical procedures and governmental regulations; along with the ability to effectively present information and respond to questions from managers and team members.
• Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations.
• Strong verbal and writing skills and good interpersonal skills.
• Proficiency with a Windows environment, Word and Excel required.

BDC Laboratories is an Equal Opportunity Employer.