40966-Scientist, Lab Operations

Job Overview
Responsible for performing a variety of technical procedures and experimental
execution in support of sample analysis and validation. Responsible for root
cause analysis, troubleshooting, and supporting process improvements.
Essential Functions
● Responsible for performing and documenting analytical procedures in
accordance with company procedures and regulatory guidelines.
● Assists in troubleshooting and process improvements to increase data
quality, lower costs, or reduce turnaround times to include, updating standard
procedures, assisting with troubleshooting.
● Acts as a technical resource for laboratory staff and support the team in
the absence of the line manager.
● Performs routine data analysis to determine if an analytical procedure is
proceeding according to expectations and that the results are within acceptable
tolerances.
● Identifies and documents potential performance errors or otherwise unusual
results and escalates to senior lab personnel.
● Prepares data analysis results for upload to LIMS system under the guidance
of senior level staff.
● Contributes to CAPA investigations, deviations, and resolution.
● Responsible for clear, accurate, and timely communications with cross
functional stakeholders.
● Assists in maintaining laboratory equipment and may offer suggestions for
new equipment.
● Assists in good housekeeping of the lab environment, consistent with 6S
standards.
● Assists in maintaining adequate inventory.
● Responsible for preparation of buffers and solutions for analysis, as
required.
● Performs and documents calibration and maintenance of laboratory equipment
as assigned.
● Performs and documents hands on training for other lab personnel in areas of
proven competency as assigned.
● Participates in continuing education through self-study, attending training
sessions and lectures and meetings.
● May lead a laboratory or cross functional projects and assist with
implementation of changes.
● May be responsible for contributing to the design and development execution
of routine methods/assays under moderate supervision.
● Supports safety, quality, and 6S requirements and initiatives.
● Complies with company's procedures and applicable regulatory requirements.
Qualifications
● Associate's Degree Req Or
● Bachelor's Degree in biology or chemistry Req
● 1 year of experience in a regulated laboratory environment. Pref
● Sound knowledge of principles, theories, and concepts in job area.
● Working knowledge of any applicable regulatory standards within area of
responsibility.
● Proficiency with relevant laboratory techniques.
● Knowledge of laboratory safety and infection control procedures and
practices including standard precautions and hazardous chemical handling ,
● Strong technical knowledge of complex testing procedures and science
supporting the analysis.
● Proficiency with complex laboratory calculations regarding batches and
specimens.
● Ability to troubleshoot laboratory equipment and resolve process issues.
● Good computer skills including proficiency with Microsoft Excel, PowerPoint
and Word.
● Effective organizational and interpersonal skills.
● Effective communication and presentation skills.
● Capable of handling multiple tasks simultaneously.
● Strong attention to detail and accuracy.
● Ability to establish and maintain effective working relationships with
coworkers, managers and clients.