Scientist I Analytical Operations Cleaning Verification

Work Schedule

Sunday- Wednesday 2:00pm-12:00am

Summary:

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

Essential Functions:

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)

REQUIRED QUALIFICATIONS

Education:

. 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 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. Demonstratable 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 computer proficiency with Microsoft Office 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 engage in and adhere to departmental systems to maintain a smooth and efficient workflow (visual management scheduling systemsetc.). Be client and patient consciousat 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 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 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.

Relocation assistance is NOT provided