CORE RESPONSIBILITIES:

• Comply with all Standard Operating Procedures (SOPs) and current Good Manufacturing Process (cGMP).
• Load packaging lines with correct lot of sterilized product.
• Load packaging lines with correct syringe film and plastic film.
• Visual inspection of product running through the packaging line.
• Removal of any and all syringes that would be considered rejects, as per standard operating procedures (SOPs).      
• Must be able to maintain Quality Standards (Inserts, Inner and Master Label reconciliation).
• Ensure that correct syringe size/fill, syringe label, lot number and expiration date, plastic wrap, box sizes, correct component with correct lot number and expiration date, box labels and inserts are being used at all times with consistent quality checks and verifications.
• Preparation of inner and outer boxes.
• Verify syringe counts, as required, during the completion of inner boxes.
• Understand machine alarms and how to proceed.
• Responsible for aiding in meeting daily/weekly/monthly production requirements in accordance with company goals, forecasts and objectives.
  • Must be able to keep line running at a minimum of 165PPM's/min.
  • Works with safety in mind. Employee performs job functions safely.
  • Works with quality in mind.
• Must be in position for at least 6 months with no NCMR's or "unplanned deviations" for 6 months.

 Additional

• Ability to effectively communicate verbally and in writing in English
• Basic Math
• The job requires the ability to make logical decisions, often quickly.
• The ability to problem solve is essential.
• Must be able to work daily overtime (2-3 hours) on regular basis up to 6 days a week.

• Strong attention to detail
• Basic computer skills with proficiency in MS Office applications is a plus
• Experience with hand tools
• Ability to stand and move throughout the department most of the time working.
• Ability to lift and/or move up to 50 pounds approximately 50% of his/her time working.
• Ability to visually inspect and clearly identify defects in the product for all of the time working.
• Ability to comply with PPE requirements that may include but not limited to ear protection, hair nets, beard/mustache covers, gloves, goggles, and/or protective shoes.