Perform all necessary operation activities related to filling of microsphere/suspension/liquid products. These activities include but are not limited to the following: Equipment Cleaning/Assembly/Setup, Equipment Operation, Batch processing. Read and follow detailed written SOP/MPR's with thorough documentation of operations according to cGMP. Ability to aseptically gown and maintain gowning qualification. Perform Area Sanitizations as needed. Maintain individual training proficiency through individual Learning Management System.
Job Description:
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.
SKILLS/ABILITIES:
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.
PERSONAL ATTRIBUTES:
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
Physical Requirements:
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.
Minimum Education & Experience Requirements:
MANUFACTURING ASSOCIATE 1
Basic Requirements:
High School diploma or equivalent.
Preferred Requirements:
0-1 year of experience in a sterile pharmaceutical operation.
Associates degree or higher in science/technical discipline.
MANUFACTURING ASSOCIATE 2
Basic Qualifications:
High School diploma or equivalent.
1-3 years of pharmaceutical manufacturing or equivalent experiences.
Preferred Qualifications:
1+ year in a sterile pharmaceutical operation.
Associates degree or higher in science/technical discipline.
MANUFACTURING ASSOCIATE 3
Basic Qualifications:
High school diploma or equivalent.
4-5 years of pharmaceutical manufacturing or equivalent experiences.
Preferred Qualifications:
2-3 years of experience in a sterile pharmaceutical operation.
Associates degree or higher in science/technical discipline