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 area's 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
