Scientist I
4 weeks ago
Job Summary:
Thermo Fisher Scientific is seeking a highly skilled Scientist I to join our team in the Analytical Operations department. As a key member of our team, you will be responsible for providing analytical support for the site cleaning verification program.
Key Responsibilities:
- 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.
- Document all experimental data in accordance with Attributable, Legible, Contemporaneous, Original and Accurate (ALCOA) principles.
- Independently carry out HPLC, HPLC/MS, UPLC/MS and physical testing analysis testing following established procedures and Analytical Methods & Standard Operating Procedures (SOPs).
- Carry out swab sampling on manufacturing equipment.
- Work proficiently 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.
Requirements:
- Bachelor's degree in chemistry or a related field.
- Minimum 1 year experience in a science-related environment.
- Equivalent combinations of education, training, and relevant work experience may be considered.
Preferred Qualifications:
- 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.
Standards and Expectations:
- Follow all Environmental Health & Safety Policies and Procedures.
- Work collaboratively with fellow team members, modelling positive team principles and partnering to meet project and departmental objectives.
- Carry out all duties within strict compliance to Patheon quality systems Standard Operating Procedures (SOPs) and Good Manufacturing Practice (GMP).
- Maintain workspace in a clean and orderly fashion.
- Actively engage in and adhere to departmental systems to maintain a smooth and efficient workflow (visual management, scheduling systems, etc.).
- Be client and patient conscious at all times.
- Understand Key Performance Indicators and strive to improve the performance of the team by identifying areas for system improvements and engage in problem solving.
- Model positive thinking and is open to change, motivating the team to adapt to shifts in priorities and new ways of working.
- Proactively identify areas for improvement in the execution of procedures.
- Communicate risks to timelines in a proactive manner.
- Consistently strives to improve skills and knowledge in related field.
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 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.
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