Job Description

Work Schedule Standard (Mon-Fri)
Environmental Conditions Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Fluctuating Temps hot/cold, No contact lens allowed; prescriptive glasses will be provided, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Strong Odors (chemical, lubricants, biological products etc.), Will work with hazardous/toxic materials

Summary:
Carry out the sampling of packaging components and raw materials according to current Good Manufacturing Practices (GMP) and all applicable Patheon Standard Operating Procedures (SOPs). Complete testing and release of Packaging Components. Inspect/test In-Process materials (i.e. tablets/capsules).
Essential Functions:

• Sample and perform all in-house physical testing of packaging components and raw materials which requires use of forklift and subsequent cleaning/sanitizing of the sampling room.
• Identify Raw Materials using Raman
• Coordinate and perform calibration of equipment
• Perform physical testing of bulk products
• Perform Administrative duties as follows:

• Movement of materials within SAP from quarantine into release, reject, or hold status
• Label materials for release / expire / re-test status
• Submitting, tracking and transportation of samples
• Log in retains / sample retains
• Reviews packaging components/ Infrared (IR) scans/ Physical Testing results
• Maintain a safe working environment and reports potential hazards.
• Perform alternating or rotating shift work (as required)

REQUIRED QUALIFICATIONS
Education:
High school diploma/General Educational Development (GED) Certificate is required
Experience:
No previous work experience required.
Preferred: Experience in a QA or QC or related field
Preferred: Experience in a cGMP environment
Preferred: Experience with SAP
Preferred: Experience using a Forklift
Equivalency:
Equivalent combinations of education, training, and relevant work experience may be considered.
Knowledge, Skills and Abilities:
Detail oriented individual with excellent organizational skills. Good verbal and written communication skills. Ability to work well independently and in a team environment. Knowledge of Good Manufacturing Practices and Standard Operating Procedures. Good understanding of safety standards. Microsoft Office skills in Word and Excel. Proficiency with 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 SOP's and Good Manufacturing Practice (GMP). Maintain workspace in a clean and orderly fashion. Actively engage in and adhere to departmental systems in order 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. Models 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/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. Safety glasses, safety shoes, lab coat, latex or similar gloves, safety apron, organic respirator occasionally.

Skills Required