Manufacturing Operations Specialist

2 weeks ago

Thousand Oaks, California, United States BioPharma Consulting JAD Group Full time
About the Role

We are seeking a highly motivated and detail-oriented Manufacturing Associate to join our team at BioPharma Consulting JAD Group. As a key member of our production team, you will play a critical role in supporting the development, clinical, and launch activities in our dynamic production environment.

Key Responsibilities
  • Hands-On Operations
    • Set up, clean, and sanitize various manufacturing equipment to ensure a safe and efficient production process.
    • Prepare buffers/media according to established Manufacturing Procedures (MPs) and Standard Operating Procedures (SOPs).
    • Perform and monitor critical processes, with the ability to execute basic troubleshooting and resolve issues in a timely manner.
    • Conduct in-process sampling and operate analytical equipment to ensure product quality and consistency.
    • 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, ensuring that all procedures are followed accurately and consistently.
    • Draft and revise routine documents, including SOPs, MPs, and technical reports, to ensure clarity and accuracy.
    • Initiate and manage quality incidents, including drafting quality reports to identify and address any issues.
  • Process Improvement
    • Identify, recommend, and implement improvements related to routine functions, ensuring that processes are optimized for efficiency and effectiveness.
    • Assist in reviewing documentation for assigned functions, such as equipment logs and batch records, to ensure accuracy and compliance.
  • 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, to maintain a sterile and safe environment.
  • Physical Requirements
    • Regularly lift up to 35 lbs., and push/pull objects requiring up to 50 lbs. of force, to ensure that tasks are completed efficiently and safely.
    • Perform physically demanding tasks, including bending, reaching, climbing, kneeling, squatting, and standing on ladders up to 6 feet off the ground, to ensure that tasks are completed safely and effectively.
    • Work on your feet for extended periods, to ensure that tasks are completed efficiently and safely.
  • Teamwork and Initiative
    • Collaborate with team members to complete operational tasks, ensuring that all tasks are completed efficiently and effectively.
    • Follow directions, documents, and policies consistently, and take initiative when necessary, to ensure that tasks are completed safely and effectively.
    • Create a positive work environment through effective interactions with team members, to ensure that all team members feel valued and supported.
Preferred Qualifications
  • Technical Writing
    • Demonstrated capability in drafting and revising technical documents, including SOPs, MPs, and technical reports.
  • Project Management
    • Skills in project management and the ability to present technical information clearly, to ensure that projects are completed efficiently and effectively.
  • Scientific Understanding
    • Ability to apply basic chemistry, biology, and physical principles in a manufacturing setting, to ensure that products are manufactured safely and effectively.
  • Safety and Training
    • May train staff on hands-on tasks and act as a safety representative, to ensure that all team members are trained and equipped to perform tasks safely and effectively.
Requirements
  • Education
    • Bachelor's degree OR Associate's degree with 4 years of experience OR High school diploma/GED with 6 years of experience, to ensure that the candidate has the necessary education and experience to perform the job requirements.
  • Shift Flexibility
    • Available to work various shifts (day, swing, graveyard), including weekends and holidays, as required by production schedules, to ensure that the production process is completed efficiently and effectively.
    • Perform activities involving periods of rigorous, repetitive work and work around high-pressure systems and heavy equipment, to ensure that tasks are completed safely and effectively.

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