MCS Manufacturing Associate NS

We are seeking a Manufacturing Associate for the Night shift. In this role, you will be integral to supporting development, clinical, and launch activities within our cutting-edge manufacturing environment. The role involves hands-on operations in a dynamic, regulated environment while ensuring compliance with GMP standards.

Key Responsibilities:

• Perform setup, cleaning, and sanitization of various manufacturing equipment.
• Prepare buffers and media according to Manufacturing Procedures (MPs) and Standard Operating Procedures (SOPs).
• Follow GMP guidelines with strict adherence to safety and compliance protocols.
• Conduct and monitor critical processes with the ability to perform basic troubleshooting.
• Collect in-process samples and operate analytical equipment.
• Perform washroom activities, including cleaning small and large-scale production equipment.
• Maintain a clean and organized workspace.
• Work in a controlled cleanroom environment while wearing full gowning, steel-toe shoes, a hairnet, and gloves.
• Initiate and document quality reports.
• Draft, revise, and review SOPs and MPs.
• Identify and suggest improvements for routine manufacturing processes.
• Assist in reviewing documentation, including equipment logs and batch records.
• Work in a physically demanding role, requiring lifting (up to 35 lbs.), pushing/pulling (up to 50 lbs.), and prolonged standing.
• Work around high-pressure systems and heavy equipment.
• Collaborate in a team environment to complete operational tasks efficiently.
• Follow documented procedures and policies at all times while taking initiative in daily operations.
• Create a positive and productive work environment through teamwork and communication.
• Flexibility to work weekends, holidays, and different shifts as dictated by production needs.

Requirements

• Bachelor’s degree OR
• Associate’s degree with 4 years of experience OR
• High school diploma/GED with 6 years of experience.

Preferred Qualifications

• Chemistry/Biochemistry laboratory experience.
• cGMP/GMP experience in a regulated manufacturing environment.
• Mechanically inclined with experience handling production equipment.
• Ability to perform repetitive tasks requiring physical movement such as bending, reaching, climbing, kneeling, squatting, and standing on ladders up to 6 feet high.

Benefits

Shift:

• Swing Shift (10:00 AM – 7:00 PM)