Manufacturing Associate-2nd Shift

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.

• 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.

• 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.

Minimum Education & Experience Requirements:

• High School diploma or equivalent.

• 0-1 year experience in a sterile pharmaceutical operation preferred.
• Associate degree or higher in a science/technical discipline.

• High School Diploma or equivalent.
• 1-3 years of pharmaceutical manufacturing or equivalent experience.

• 1+ year experience in a sterile pharmaceutical operation.
• Associate degree or higher in a science/technical discipline.

• High School diploma or equivalent.
• 4-5 years of pharmaceutical manufacturing or equivalent experience.

• 2-3 years experience in a sterile pharmaceutical operation.
• Associate degree or higher in a science/technical discipline.

• High school diploma or equivalent.
• 4-5 years of experience in a pharmaceutical operation.

• Associate degree or higher in science/technical discipline.
• 4-5 years of experience in a sterile pharmaceutical operation.

• Occasional periods of repetitive motion.
• Walking, lifting, pushing and pulling carts, reaching, climbing, and bending may all be required.
• Ability to operate all types of production equipment.
• Ability to read, understand, and follow company SOP guidelines.
• Ability to lift/move up to 50 lbs. Ability to team lift up to 100 lbs.
• Ability to stand in steel-toed shoes for a minimum of 7 hrs.

Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any qualified applicant or employee because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other characteristic protected by local, state or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.

Alkermes is an E-Verify employer.