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BioPharma Consulting JAD Group

BioPharma Consulting JAD Group is hiring: MCS Manufacturing Associate in Thousan

BioPharma Consulting JAD Group, Thousand Oaks, CA, United States, 91362


Job Description

Job Description

We are seeking a MCS Manufacturing Associate to join their team in Thousand Oaks, CA. This vital role supports the company's clinical and development activities within a fast-paced manufacturing environment. Under general supervision, the associate will execute a range of manufacturing operations in strict accordance with Standard Operating Procedures (SOPs) and Good Manufacturing Practices (GMP).

Responsibilities:

  • Perform setup, cleaning, and sanitization of manufacturing equipment.
  • Prepare buffers and media according to manufacturing procedures (MPs) and SOPs.
  • Adhere to GMP protocols and safety standards while performing operations.
  • Monitor and execute critical processes, troubleshooting basic issues as needed.
  • Conduct in-process sampling and operate analytical equipment.
  • Maintain an organized and clean workspace in alignment with GMP and safety regulations.
  • Perform washroom activities, including cleaning small and large production equipment.
  • Draft, revise, and review documents such as SOPs, MPs, and quality records.
  • Identify and implement process improvements for efficiency and compliance.
  • Participate in quality assurance activities, such as initiating quality reports and reviewing documentation.
  • Perform physically demanding tasks, including lifting (up to 35 lbs.) and pushing/pulling (up to 50 lbs.).
  • Work in a cleanroom environment, following full gowning protocols and utilizing personal protective equipment (PPE).
  • Execute and monitor critical manufacturing processes.
  • Perform routine validation protocols and comply with GMP standards.
  • Draft and revise documents such as MPs, SOPs, and technical reports.
  • Initiate and own quality records, including CAPA and CAPA-EV.
  • Identify and recommend process improvements, implementing approved changes.
  • Train team members in operational tasks and act as a safety representative when required.
  • Participate in cross-functional teams to support manufacturing goals.
  • Apply technical and scientific knowledge to troubleshoot and support the introduction of new technologies.

Requirements

Qualifications:

  • Bachelor's degree OR
  • Associate degree and 4 years of relevant experience OR
  • High school diploma/GED and 6 years of relevant experience.

Preferred Qualifications:

  • Familiarity with GMP requirements and regulatory standards in pharmaceutical manufacturing.
  • Ability to interpret and apply basic principles of chemistry, biology, and physics.
  • Experience in technical writing for documenting manufacturing processes.
  • Mechanically inclined with troubleshooting experience.

Physical Requirements:

  • Able to perform repetitive tasks and remain on your feet for long periods.
  • Regularly lift up to 35 lbs. and push/pull objects requiring up to 50 lbs. of force.
  • Perform physical movements, including bending, climbing, kneeling, squatting, and reaching.