Scientist I - Analytical Operations - Cleaning Verification
Work Schedule
Second Shift (Afternoons)Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)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.
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:
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.
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 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.