Work Schedule
First Shift (Days)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, 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.)Job Description
How will you make an impact?
Coordinate documentation of batch records, forms, labels etc.
Shift schedule: 8 AM - 4:30 PM
What will you do:
Coordinate the flow of completed Batch Records (BRs) for compliance to Good Manufacturing Practices (GMP), Standard Operating Procedures (SOP) and Quality Assurance (QA) standards.
Assist and make recommendations to operators in correcting documentation errors and providing adequate explanations. Provides appropriate training to operators in regards to documentation improvements.
Assist management by recommending revisions to documents (for clarity) based on types of documentation errors being observed and QA comments on BRs.
Responsible for controlling and printing all shelf pack and shipper barcode labels and coordinating with Tech Ops department when there are label concerns prior to batch execution.
Provide support for material handlers with all aspects of controlling, accounting for, and the security of labels, inserts & printing mats within the Packaging department. Ensure that the correct approved labels are dispensed to an order in order to prevent label mix-up, which would result in a recall.
Complete documentation for samples and delivery of samples.
Maintain training memos, SOP revision follow ups by obtaining required signatures in a timely manner.
Prepare and maintain cleaning and equipment use log books.
Maintain a safe working environment and reports potential hazards.
Perform alternating or rotating shift work.
How will you get here?
Education:
High school diploma/General Educational Development (GED) Certificate is required
Experience:
Minimum 3 years of experience in the pharmaceutical industry in a manufacturing function. Packaging experience preferred.
Equivalency:
Equivalent combinations of education, training, and relevant work experience may be considered.
Knowledge, Skills and Abilities:
Knowledge of Good Manufacturing Practices and ability to follow SOPs. Good written and oral communication skills. Strong accuracy and attention to detail. Ability to multi-task, meeting tight deadlines in a fast paced environment. Proficiency with Microsoft Office software applications. 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 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. 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 manufacturing/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 up to 40 pounds; arm, hand and finger dexterity; visual acuity to 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. Usually in a comfortable environment but with regular exposure to factors causing moderate physical discomfort from such things as dust, loud noise, bright lights, fumes or odour. Use of Personal Protective equipment is required and may include any of the following: safety glasses, safety shoes, lab coat, gloves, hair net, beard cover, safety apron, respirator.