Job Description

To inspect the GMP (Good Manufacturing Practices) vials - product and glass vials - for defects. Perform label and packaging activities for finished product.

Responsibilities:

• 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

Qualifications:

Basic Requirements

• High School diploma or equivalent.

Preferred Requirements

• 0-1 year of experience in a sterile pharmaceutical operation preferred.
• Associate degree or higher in a science/technical discipline

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.