Manufacturing Associate-Filling 3rd Shift

Alkermes•Wilmington, OH

1d•Onsite

About The Position

This position is based in Wilmington, OH and involves performing all necessary operation activities related to the filling of microsphere/suspension/liquid products. These activities include equipment cleaning, assembly, setup, and operation, as well as batch processing. The role requires reading and following detailed written SOPs/MPRs with thorough documentation of operations according to cGMP, and the ability to aseptically gown and maintain gowning qualification. Area sanitizations and maintaining individual training proficiency are also key aspects 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
Occasional periods of repetitive motion.
Aseptic gowning must be maintained, including an annual requalification.
Walking, lifting, pushing and pulling carts, reaching, climbing, and bending may all be required.
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 experience.
1+ year in a sterile pharmaceutical operation.
4-5 years of pharmaceutical manufacturing or equivalent experience.
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.