This position is based in Wilmington, OH.
Summary:
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
Job Description:
- 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 Manager
- Shift coverage and weekend work may be required
Minimum Education & Experience Requirements:
Manufacturing Associate I
Basic Requirements
- High School diploma or equivalent.
Preferred Requirements
- 0-1 year experience in a sterile pharmaceutical operation preferred.
- Associates degree or higher in a science/technical discipline
Manufacturing Associate II
Basic Qualifications:
- High School Diploma or equivalent
- 1-3 year of pharmaceutical manufacturing or equivalent experience.
Preferred Qualifications:
- 1+ year experience in a sterile pharmaceutical operation
- Associates degree or higher in a science/technical discipline
Manufacturing Associate III
Required Education and Experience
- High School diploma or equivalent.
- 4-5 years’ experience in pharmaceutical Manufacturing
Preferred Education and Experience
- 2-3 years’ experience in a sterile pharmaceutical operation
- Associates degree or higher in a science/technical discipline
Knowledge/Skills Needed:
- 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 lift / move 50lbs. overhead. Ability to team lift 100 lbs
- Ability to operate all types of production equipment (i.e. Rockwell HMI, CIP system, etc.)
- Ability to gown for clean room operations
- Ability to read, understand, and accurately follow company SOPs and guidelines
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