Perform all necessary operations activities related to recrystallization and micron-suspension. These activities include but are not limited to the following: batch records, operating procedures, equipment manuals, various specifications, cleaning, sterilization, filtering, transferring materials aseptically, and various other GMP-related tasks. Other responsibilities include SOP writing and reviewing GMP 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