Manufacturing Associate-2nd Shift

Alkermes • Wilmington, OH

8d • Onsite

About The Position

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.

Requirements

• General math skills, including simple algebra.
• General knowledge of and adherence to Current Good Manufacturing Practices
• General knowledge of HAZCOM, RCRA, and other Safety requirements
• Good level of mechanical aptitude; ability to perform minor non-routine equipment adjustments and diagnose improperly operating equipment.
• General computer word processing/spreadsheet skills
• Good written communication
• Excellent documentation skills
• Ability to gown in an aseptic manner for clean room operations.
• High School diploma or equivalent.
• 1-3 years of pharmaceutical manufacturing or equivalent experience (for Manufacturing Associate II).
• 4-5 years of pharmaceutical manufacturing or equivalent experience (for Manufacturing Associate III).
• 4-5 years of experience in a pharmaceutical operation (for Sr Manufacturing Associate).

Nice To Haves

• 0-1 year experience in a sterile pharmaceutical operation preferred (for Manufacturing Associate I).
• Associate degree or higher in a science/technical discipline (for Manufacturing Associate I).
• 1+ year experience in a sterile pharmaceutical operation (for Manufacturing Associate II).
• Associate degree or higher in a science/technical discipline (for Manufacturing Associate II).
• 2-3 years experience in a sterile pharmaceutical operation (for Manufacturing Associate III).
• Associate degree or higher in a science/technical discipline (for Manufacturing Associate III).
• Associate degree or higher in science/technical discipline (for Sr Manufacturing Associate).
• 4-5 years of experience in a sterile pharmaceutical operation (for Sr Manufacturing Associate).

Responsibilities

• Read and follow detailed written SOPs / Procedures
• Document all work as required by cGMPs on a timely basis.
• Executes tasks as directed with close attention to detail.
• Monitors Process with close attention to detail.
• Abide by all safety requirements as defined by the company.
• Can work independently without constant supervision.
• Follows Alkermes internal policies.
• Works well in a team environment.
• Perform facility/equipment cleaning and set-up.
• Assist with Development activities and Validation as required.
• Other tasks as assigned by the Manager.
• Shift coverage and weekend work may be required.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED