Lead Visual Inspection Technician - 2nd Shift

Job :

Location:

US-NC-Morrisville

Position Type:
Full-Time

Working Hours:

2nd

Shift: Monday
- Friday, 3:00pm - 11:30pm

At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record.

The Lead Visual Inspection Technician is accountable for results in a fast-paced environment and responsible for performing tasks for the quality inspection of sterile injectable products for commercial distribution and clinical trials. The Lead Visual Inspection Technician handles and inspects manufactured products by following standard operation procedures (SOPs) and batch records in accordance with current Good Manufacturing Practices (cGMPs). In addition, the Lead Visual Inspection Technician employs acceptable techniques while working in manufacturing environments, including PPE gowning, and provides training and coaching to less experienced Visual Inspection Technicians as required.

The Lead Visual Inspection Technician interacts with customers as needed.

• 100% on-site position.
• 2nd
  
  Shift: Monday
  - Friday, 3:00pm - 11:30pm.

• Follows applicable SOPs and cGMPs to perform assigned duties and tasks.
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
• Conducts visual inspection of sterile liquids in accordance with regulatory agency guidelines.
• Visually identifies debris, air lines, and other defects in sterile liquids.
• Documents activities in real time on controlled documentation and legibly, per SOPs and cGMPs.
• Performs component counting and basic math calculations.
• Performs cleaning of rooms, tools, and equipment.
• Performs specific visual inspections per SOPs.
• Ensures product meets appearance specifications before sending the product for packaging.
• Performs bulk packaging for product vials for shipment to another facility.
• Operates material handling equipment.
• Demonstrates proficiency in all department procedures and trains and coaches other technicians.
• Provides work instruction and oversee daily work assignments in the absence of the supervisor as needed.
• Works occasional hours outside of scheduled shift based on business needs, which may include weekend work.
• Other duties as assigned.

• High School diploma or equivalent with 3
  -5+ years of relevant experience or an associate degree with at least 1 year of relevant experience.
• GMP experience in a regulated industry preferred. Medical device or similar experience required.

• 20/20 correctable near-sighted vision in both eyes, tested annually required.
• Ability to see and distinguish colors required.
• Ability to perform basic math calculations, including product accountability calculations and rounding required.
• Ability to read and comprehend detailed written instructions required.
• Ability to move materials throughout the facility using appropriate methods and equipment required.
• Excellent verbal and written communication, documentation, detail orientation and organizational skills required.
• Ability to train, coach and develop others required.
• Proficiency in basic computing skills required.
• Awareness of or prior experience with cGMP practices and procedures preferred.
• Demonstrated leadership.
• Experience in training team members preferred.

• Up to 5% domestic travel required.

The physical demands and work environment characteristics described here are representative of those that must be met or encountered by an employee to successfully perform the essential functions of this…