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Production Specialist

2 months ago

Charlottetown, Prince Edward Island, Canada Next Level Group Full time
Job Summary

We are seeking a highly skilled and detail-oriented Production Specialist to join our team at Next Level Group. As a key member of our production team, you will be responsible for ensuring the highest quality standards in our manufacturing processes.

Key Responsibilities
  • Manufacturing Operations
    • Perform sterile manipulations in a controlled environment, adhering to strict safety protocols.
    • Maintain cell lines, completing media changes and cell passages as required.
    • Operate and maintain production instruments and equipment, ensuring optimal performance and efficiency.
  • Quality Control
    • Perform sterile cell culture and viral infection processes, ensuring compliance with regulatory requirements.
    • Write and review batch records, SOPs, and qualification documents for viral/Renogen operations.
    • Complete timely SAP postings and maintain department inventory, ensuring accurate tracking and reporting.
  • Collaboration and Communication
    • Collaborate with cross-functional teams to plan production, testing, and product release, ensuring timely completion of projects.
    • Communicate effectively with colleagues and management, providing updates on production progress and any issues that may arise.
  • Safety and Compliance
    • Comply with safety requirements, cGMP, SOP, and manufacturing documentation, ensuring a safe working environment.
    • Assist in maintaining production equipment in good condition, adhering to manufacturer's specifications.
    • Maintain the cleanliness of production areas, following disinfection procedures and clean room protocols.
Requirements
  • Education and Experience
    • High School (Grade 12) diploma is a must.
    • 1-2 years of pharmaceutical/biological manufacturing experience in a GMP environment is preferred.
    • 1-2 years of experience in aseptic techniques or cell culture experience is preferred.
  • Skills and Qualifications
    • Excellent interpersonal skills, both communication and written.
    • Outlines of Production, cGMP guidelines, and HSE regulations.
    • Experience performing investigations and writing deviations.
    • Intermediate/Expert computer skills using MS Office (Word, Excel, PowerPoint).
    • Thorough technical understanding of quality systems and regulatory requirements.
  • Physical Demands
    • Must be able to work shift work (12-hour daytime shifts, 3-4 days/week including some weekends) and overtime as required.
    • Required to assist in disinfection procedures involving hazardous chemicals requiring the use of a respirator.
    • Must be able to lift, move, and maneuver small-medium sized equipment and raw materials – up to 50lbs.
    • Requires ability to stand or sit for long periods of time.
    • Requires frequent ladder or stair climbing.
What We Offer

As a Production Specialist at Next Level Group, you will have the opportunity to work in a dynamic and fast-paced environment, contributing to the success of our company. We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.