Manufacturing Associate-Filling 1st Shift

Alkermes•Wilmington, OH

2d•Onsite

About The Position

This position is based in Wilmington, OH. The role involves performing all necessary operation activities related to the filling of microsphere/suspension/liquid products. These activities include equipment cleaning, assembly, setup, operation, and batch processing. The associate will read and follow detailed written SOPs/MPRs with thorough documentation of operations according to cGMP. Aseptic gowning and maintaining gowning qualification is required, along with performing area sanitizations as needed. Maintaining individual training proficiency through the Learning Management System is also a key part of the role.

Requirements

High School diploma or equivalent.
General knowledge of aseptic fundamentals.
General math skills, including using metric weight system.
General Knowledge and Adherence to Current Good Manufacturing Practices.
General Knowledge 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 skills.
Excellent documentation skills.
Positive Attitude
Integrity/Ethics
Adaptability/Flexibility
Dependability
Detailed Oriented
Self-Motivated
Responds Quickly to Assignments
Works Well in a Team Environment.
Adapts Well to Changing job duties.
Takes Ownership and is Willing to Learn new tasks/skills
Manufacturing Associate 1 Basic Qualifications: High School diploma or equivalent.
Manufacturing Associate 2 Basic Qualifications: High School diploma or equivalent.
Manufacturing Associate 3 Basic Qualifications: High school diploma or equivalent.
Ability to operate all types of production equipment (i.e., Rockwell HMI, Autoclaves, etc.)
Ability to read, understand, and accurately follow company SOP’s and guidelines.
Ability to lift/move up to 50 lbs. overhead.
Ability to team lift up to 100 lbs.
Ability to stand in steel-toed shoes for a minimum of 7 hrs.

Nice To Haves

0-1 year of experience in a sterile pharmaceutical operation.
Associates degree or higher in science/technical discipline.
1-3 years of pharmaceutical manufacturing or equivalent experiences.
1+ year in a sterile pharmaceutical operation.
2-3 years of experience in a sterile pharmaceutical operation.

Responsibilities

Read and follow detailed written SOP’s/MPR’s/Procedures.
Document all work as required by cGMP’s on a timely basis.
Execute tasks as directed with close attention to detail.
Monitors process with close attention to detail.
Follows Alkermes internal policies.
Abide by all safety requirements as defined by the company.
Perform Aseptic Gowning and maintaining gowning qualification. (this includes wearing of hood, coverall, boots, mask, goggles, gloves)
Perform clean room sanitizations.
Perform equipment prep/assembly/setup.
Operate equipment used in filling of microspheres/suspensions/liquid products.
Assist with Development and Validation activities as required.
Other tasks as assigned by Manager.
Shift coverage and weekend work may be required.