Manufacturing Associate I-Inspection – 13232
Alkermes, Inc.
To inspect the GMP (Good Manufacturing Practices) vials – product and glass vials – for defects. Perform label and packaging activities for finished product.
KEY DUTIES:
– Inspect vialed product and empty glass for defects
– Perform daily process activities in compliance with standard operating procedures (SOPs)
– Prepare all process-specific and ancillary equipment (i.e., glassware, apparatus) for use in assigned areas.
– Assist in writing and implementing areas process documents
– Operate equipment in compliance with SOPs
– Assure compliance with cGMP requirements (current good manufacturing practices)
– Work non-routine hours as required to maintain production schedule
– Perform label and packaging activities for finished product
– Complete and review associated production records and daily trending
– Train new inspectors in accordance with vial inspector certification procedures
– Assist other manufacturing functions (Formulation, Fill, Materials) as required
SKILLS/ABILITIES:
– Organization and interpersonal Skills (Oral, Written, etc.)
– Good Computer and Database Skills
– Comprehensive training focused on current Good Manufacturing Practices (cGMP) in the pharmaceutical industry.
PERSONAL ATTRIBUTES:
– Good math skills
– Self-motivated
– Good visual acuity
– Team Oriented
– Effective organization skills and attention to detail
– Ability to work with minimal supervision
– Ability to work flexible hours
– Ability to work hands-on
PHYSICAL REQUIREMENTS
– Prolonged periods of sitting or standing.
– Periods of repetitive motion
– Walking, squatting, lifting, pushing and pulling carts, reaching, climbing, and bending may all be required.
– Steel-toe shoes, scrubs, and other PPE equipment must be worn based on the job being performed.
– Employee must be able to pass a vision exam before employment and annually.
Qualifications:
Basic Requirements
– High School diploma or equivalent.
Preferred Requirements
– 0-1 year experience in a sterile pharmaceutical operation preferred.
– Associate degree or higher in a science/technical discipline