Thermo Fisher Scientific Data Review & Lab Support Specialist in Bend, Oregon
Data Review & Lab Support Specialist
Supports the laboratory instrument calibration system, the laboratory training plan, and the data management program that includes data review. Performs the activities in the group according to a set schedule to meet site timelines and in accordance with Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMPs) and corporate standards.
Completes assigned tasks in a timely manner and understands and supports Key Performance Indicators (KPIs) across their function and actively engages in achieving excellent client service results.
Completes thorough and timely review of data, notebooks, stability tables and other laboratory related documentation in accordance with site and global requirements.
Periodically reviews/updates the SOPs related to instruments and qualification, training, data review, documentation and integrity, and general lab guidance as it relates to the position.
Assists in troubleshooting malfunctioning equipment and appropriately communicates issues or risks to their supervisor in a timely and effective manner.
Assists in the training of laboratory employees and helps support documentation according to site and global SOPs.
Helps support the laboratory instrument calibration program, the laboratory training plan, and the data management program that includes data review.
Ensures that work is performed in a safe and responsible manner in order to create an injury-free and incident-free workplace; complies with all job-related safety and other training requirements.
Maintains good working relationships with cross-functional teams and is able to communicate in a respectful manner; believes that each person in the organization is part of one team and is able to participate as part of that team.
Performs other duties as assigned by management.
Bachelor’s degree in a scientific or related discipline required.
Minimum of two years relevant laboratory experience with some knowledge of laboratory operating systems required.
Equivalent combinations of education, training, and relevant work experience may be considered.
Good knowledge of Microsoft office products and chromatography software. Good knowledge of regulatory guidances (such as ICH, USP, EP, JP, FDA, MHRA), quality control statistics, documentation and adherence to SOPs. Good knowledge of common laboratory equipment, testing, procedures, and results (on equipment such as HPLC, Dissolution, KF, GC, FTIR, TOC). Advanced organizational, skills. Ability to perform several tasks simultaneously to meet deadlines; ability to draft quality technical reports, ability to effectively collaborate with others to achieve team goals and expectations. Effective oral & written communication and interpersonal skills.
Position requires ordinary ambulatory skills and physical coordination sufficient to move about office and laboratory locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pound pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.
This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.
Nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.
Please take note that we require a negative drug screen, administered by our third-party vendor, as a condition of employment.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.