MCS Manufacturing Associate

2 weeks ago

Thousand Oaks, United States BioPharma Consulting JAD Group Full time

The BioPharma Consulting JAD Group is currently seeking a highly motivated MCS Manufacturing Associate to join our team. This role offers the opportunity to support development, clinical, and launch activities in a dynamic production environment.

Key Responsibilities:

  • Hands-On Operations:
    • Set-up, clean, and sanitize various manufacturing equipment.
    • Prepare buffers/media following Manufacturing Procedures (MPs) and SOPs.
    • Perform and monitor critical processes, with the ability to execute basic troubleshooting.
    • Perform in-process sampling and operate analytical equipment.
    • Execute washroom activities, including cleaning small and large-scale equipment used in production.
  • Compliance and Documentation:
    • Adhere strictly to GMP documents (SOPs, MPs) with a focus on safety and compliance.
    • Draft and revise routine documents, including SOPs, MPs, and technical reports.
    • Initiate and manage quality incidents, including drafting quality reports.
  • Process Improvement:
    • Identify, recommend, and implement improvements related to routine functions.
    • Assist in reviewing documentation for assigned functions, such as equipment logs and batch records.
  • Clean Room Environment:
    • Work in a clean room environment, following all gowning and safety protocols, including wearing steel toe shoes, full clean room gowning, hairnet, and gloves.
  • Physical Requirements:
    • Regularly lift up to 35 lbs., and push/pull objects requiring up to 50 lbs. of force.
    • Perform physically demanding tasks, including bending, reaching, climbing, kneeling, squatting, and standing on ladders up to 6 feet off the ground.
    • Work on your feet for extended periods.
  • Teamwork and Initiative:
    • Collaborate with team members to complete operational tasks.
    • Follow directions, documents, and policies consistently, and take initiative when necessary.
    • Create a positive work environment through effective interactions with team members.

Preferred Qualifications:

  • Technical Writing:
    • Demonstrated capability in drafting and revising technical documents.
  • Project Management:
    • Skills in project management and the ability to present technical information clearly.
  • Scientific Understanding:
    • Ability to apply basic chemistry, biology, and physical principles in a manufacturing setting.
  • Safety and Training:
    • May train staff on hands-on tasks and act as a safety representative.

Requirements

Basic Qualifications:

  • Education:
    • Bachelor’s degree OR Associate’s degree with 4 years of experience OR High school diploma/GED with 6 years of experience.
  • Shift Flexibility:
    • Available to work various shifts (day, swing, graveyard), including weekends and holidays, as required by production schedules.
    • Perform activities involving periods of rigorous, repetitive work and work around high-pressure systems and heavy equipment.

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