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.
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.
