Manufacturing Associate I

Manufacturing Associate I

Requirements

• High School Diploma /Associates Degree with exposure to science & math coursework
• 0-2 years of cGMP experience
• Ability to follow detailed instructions and to maintain accurate records and notes
• Ability to work effectively in a team environment
• Excellent oral and written communication skills
• Ability to work occasional weekends, holidays or overtime as needed
• Ability to lift up to 20 Kg
• Familiarity with MS Office applications (Word, Excel)

Responsibilities

• Performs downstream operations safely and compliantly in accordance with OSHA and cGMP guidelines. Downstream operations include but are not limited to; dispensing and sampling of raw materials, buffer preparation, column packing, UF/DF, chromatography, viral inactivation and filtration, product sampling, and filling of bulk drug product or intermediate.
• Utilizes standard operating procedures and documents cGMP activities within batch records and logbooks applying good cGMP documentation and data integrity practices.
• Performs oversight of process operations and monitors equipment and critical process parameters. Escalates any issues or abnormalities to management and shift leads, senior associates and/or system matter experts. Participates in resulting troubleshooting activities as necessary.
• Completes setup, use and cleaning (as necessary) of cGMP production equipment.
• Creates and revises SOPs (standard operating procedures) and MBRs (master batch records) as appropriate.
• Proactively works with senior associates, system matter experts, and management to achieve training competency in production operations.
• Maintains a clean and orderly production area. Positively engages and collaborates with other team members to ensure daily production tasks are completed in a timely manner.
• Participates in investigations of safety or quality issues as necessary.
• Participates and supports a culture of continuous improvement. Effectively collaborates with cross functional partners such as Quality Assurance, Quality Control, Supply Chain, and Facilities.

Preferred Qualifications

No preferred qualifications provided.