Alkermes
Entry level position for persons to manufacture commercial scale batches
Responsibilities
· Production, filling and inspection of pharmaceutical formulations.
· Assist with facility cleaning and operational maintenance.
· Assist with facility and process validations as required.
· Perform aseptic production operations and validations.
· Assist with environmental and water system monitoring as required.
· Assist with clean room sanitization as required.
· Assist with RCRA and safety inspections as required.
· Document all work as required by CGMPs on a timely basis.
· Read and follow all Company SOPs and guidelines.
· Abide by all safety requirements as defined by the company.
· Other tasks as assigned by team leader.
Qualifications
SKILLS/ABILITIES:
· Basic knowledge of the Scientific Method
· Basic math skills, including simple algebra
· Basic knowledge of and adherence to current GMP.
· Basic knowledge of chemistry and biology.
· Basic knowledge of steam/dry heat sterilization theories.
· Basic knowledge of HAZCOM, RCRA and other Safety requirements.
· Basic level of mechanical aptitude.
· Good documentation skills.
· Ability to lift / move 40 lbs. overhead.
· Ability to learn how to operate all types of production equipment (I.e. Autoclave, Honeywell DCS panels, CIP system, Dry Heat Oven, Process Waste system, etc.).
· Ability to read, understand and accurately follow company SOPs and guidelines.
Bachelors Degree