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, Cold Room/Freezers -22degreesF/-6degrees C, Laboratory Setting, 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 /APR samples
Reviews packaging components/ Infrared (IR) scans/ Physical Testing results
Investigation duties as follows:
Investigate and follow up for Out Of Specifications (OOS) investigations
DR investigations
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 required
Preferred: College/Technical School diploma in ?Food and Drug diploma?
Experience:
Required: Minimum 1 year of work 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:
Knowledge of testing packaging components, sampling techniques, Good Manufacturing Practices and Standard Operating Procedures. Good understanding of safety standards. Self motivated and able to work in a team environment. Excellent attention to detail. Good interpersonal, communication and organizational skills. Knowledge of SAP. Microsoft Office skills in Word, Excel and Access. 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.
Disclaimer:
This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as a comprehensive statement of work, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.
Nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully align with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.

Skills Required