Principal Lab Tech In Vitro

Principal Duties and Responsibilities

• May perform routine test article/product preparation according to work instructions.
• May execute routine testing per SOPs, with appropriate data analysis.
• Performs routine calculations, interprets results, and can route all positive results or unusual testing occurrences to Management.
• May provide on the job training.
• Assure testing/test article preparation is performed within due dates.
• May prepare and maintain cell lines and reagents required for testing, as applicable for primary department.
• Maintain relevant supplies, materials, and equipment used in routine testing.
• Maintain ancillary records (logbooks, worksheets).
• Conduct routine studies independently. May be requested to conduct more involved studies.
• Participate in the improvement of documents, test systems, quality systems, and workflow.
• May be responsible for checking laboratory equipment, being on-call, and responding to continuous monitoring alarms. The associate will respond in accordance with criteria outlined in Standard Operating Procedures.
• May perform Environmental Monitoring, clean and disinfect cleanroom suites.
• May order and/or stock supplies subject to approval.
• May be required to perform personal gowning environmental testing, and submit organisms from gowning, environmental and sterility test positives for identification and inclusion in monthly trending data.
• Responsible for review of incoming test articles and paperwork for appropriateness and accuracy and taking all concerns to management as required.
• May be required to operate autoclave.

Qualifications and Skills

• Bachelor’s degree in scientific discipline appropriate for hiring department and at least two years of related laboratory experience, or a high school diploma with at least 6 years of relevant laboratory experience.

Technical Competencies

• Awareness of applicable guidelines and regulations appropriate for primary department, these may include USP, ISO, CTFA, FSA, ICH, EP, and/or JP.
• Knowledge of metric system, scientific applications, experimental design, and data evaluation.
• Can draft technical documents and communications (SOPs, protocols, Trackwise records).
• Proficient at applicable systems (LIMS, Trackwise, MasterControl, etc.) as appropriate per primary department.
• Ability to work in GMP/GLP environment.