Manufacturing Associate-2nd Shift-Bulk

Alkermes; Wilmington (OH); On-site; USD 42,000 - 62,000; Full time

Job summary

Alkermes is seeking a manufacturing operator for the 2nd shift (2:00pm–12:30am, Mon, Tue, Wed and Fri). The role involves performing bulk manufacturing activities, including equipment cleaning, setup, operation, and batch processing, with strict adherence to SOPs and cGMP documentation.

The position requires documenting operations, collecting samples, monitoring equipment and processes, performing minor maintenance, and maintaining training proficiency via the LMS.

Qualifications

• Experience operating manufacturing equipment in a GMP environment.
• Ability to read and follow detailed SOPs and batch records.
• Strong documentation skills and attention to detail.
• Willingness to work 2nd shift.

Responsibilities

• Operate equipment for bulk manufacturing per SOPs.
• Perform equipment cleaning, setup, and routine maintenance.
• Collect samples, monitor processes, and document results.
• Review and write cGMP documentation as needed.
• Maintain training proficiency through LMS.

Skills

Equipment operation

SOP adherence

cGMP documentation

Batch processing

Equipment cleaning

Job description

This is a 2nd shift position. The hours for the position are 2:00pm to 12:30am Monday, Tuesday, Wednesday and Friday.

Perform all necessary operation activities in bulk manufacturing. These activities include but are not limited to the following: Equipment Cleaning, Equipment Set-up, Equipment/Automation Operation, and Batch Processing. Reads and follows detailed written SOPs / Procedures and detailed documentation of operations according to cGMP. Performs sample collection, equipment/process monitoring, and minor maintenance. Maintain individual training proficiency through individual Learning Management System. Other responsibilities include SOP writing and review of cGMP documentation.