MCS Manufacturing Associate

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.