Perform all necessary operations activities manufacturing. These activities include, but are not limited to the following: Equipment Cleaning, Equipment Set-up, Equipment/Automation Operation, Batch Processing, and Aseptic Manufacturing. Read 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
Read and follows 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.
Perform aseptic operations.
Other tasks as assigned by Manager.
Shift coverage and weekend work may be required
High School diploma or equivalent
0-1 year experience in a sterile pharmaceutical operation
Associates of BS degree in a science/technical Discipline
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 in an aseptic manner for clean room operations.
Ability to read, understand and accurately follow company SOPs and guidelines.
Personal Attributes Needed:
Willing to learn new tasks, skills.
Works well in a team environment.
Responds quickly to assignments.
Readily adapts to changing job duties.
Manages time well; ability to multi-task
Effective communication skills, written and verbal
Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Alkermes is an E-Verify employer.
Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.