Scientist I - Analytical Operations - Cleaning Verification

at  Thermo Fisher Scientific

JOB DESCRIPTION

Business Title: Scientist I – Analytical Operations – Cleaning Verification
Issue Date: 23.FEB.2024
Revision #: 2
Afternoons

SUMMARY:

Provide analytical support for the site cleaning verification program. Collect samples and perform analytical testing as assigned for on previously cleaned manufacturing equipment, using HPLC, UPLC, and mass spectroscopy as required by standard methods. Make detailed observations, review, document, and communicate test results.

EDUCATION:

B.Sc. in chemistry or a related field.

EXPERIENCE:

Minimum 1 year experience in a science related environment.
Equivalency:
Equivalent combinations of education, training, and relevant work experience may be considered.
Knowledge, Skills and Abilities:
Good understanding of basic chemistry and experience with common laboratory equipment and operation. Good understanding of chromatographic separations. Knowledge of qualitative and quantitative chemical or microbiological analysis. Awareness of quality and regulatory requirements in the pharmaceutical industry. Good problem-solving skills and logical approach to solving scientific problems. Demonstrable interpersonal and communication skills (both oral and written). Ability to read and interpret technical procedures and governmental regulations. Ability to apply mathematical operations to such tasks as determination of test reliability, analysis of variance, and correlation techniques. Works well independently and in a team environment. Demonstrated computer proficiency with Microsoft Office programs. Proficiency in the English Language.

PHYSICAL REQUIREMENTS:

Position requires ordinary ambulatory skills and physical coordination sufficient to move about lab/office 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. Safety glasses, safety shoes, lab coat, latex or similar gloves, safety apron, organic respirator occasionally

• Document all experimental data in accordance with Attributable, Legible, Contemporaneous, Original and Accurate (ALCOA).
• Independently carry out HPLC, HPLC/MS, UPLC/MS and physical testing analysis testing following established procedures Analytical Methods & Standard Operating Procedures (SOPs).
• Carry out swab sampling on manufacturing equipment.
• Work Proficiency with Empower, NuGenesis, MS Word & Excel Software.
• Perform basic troubleshooting to overcome system suitability failures.
• Recognize and report unexpected or Out Of Specification (OOS) results immediately to the Supervisor and conducts laboratory investigations under direction.
• Maintain a safe working environment and report potential hazards.
• Perform alternating or rotating shift work (as required)