SUMARY:
The Supervisor of Visual Inspection reports directly to the Manufacturing Manager of the facility. You will be responsible for supervising a team of inspection technicians, maintaining timely product inspections, documentation and bulk packing of sterile clinical and commercial products following cGMP's and in-house SOPs.
RESPONSIBILITIES:
- Provides technical support, training and leadership to Visual Inspection Technicians
- Creates training modules, and performs new employee training
- Oversee areas with the responsibility of examining materials for quality, defects and planning of work
- Early detection and proactive troubleshooting of problems arising on the line to prevent downtime
- Assist and perform investigations, and resolve deviations associated to Visual Inspection process
- Manage, create, plan and maintain metrics relating to defect rate, inspection throughput, and on time and right first time delivery
- Ensure visual inspection process and operator qualification process maintains compliance to applicable regulatory markets
- Maintains compliance of company policies, safety standards, quality specifications and regulatory requirements
- As needed participate in audits by customer and regulatory bodies as the Visual Inspection SME
EDUCATION & EXPERIENCE
- AS/BS degree in related field is highly preferred.
- Relevant experience in sterile product visual inspection 4+ years
- 5 years' experience in a supervisory role or 8 in a lead role
- SME in Visual Inspection of large and small volume parenteral, both liquid and lyophilized presentations
- Experience with inspection and manufacturing equipment/processes that comply with regulatory requirements
- Experienced with GMPs, SOPs and working within an FDA / EU regulated environment
PHYSICAL REQUIREMENTS
- Ability to read, understand, follow and comply with technical and written documents (SOPs) written in English
- Requires the ability to communicate effectively using speech, vision, hearing and written word
- Must be able to work while wearing PPE for all GMP areas for an entire shift (Includes non-latex gloves, hair beard covers and lab coats)
- The employee is regularly required to sit while performing motions requiring high manual dexterity for up to 8 hours per day
- Specific vision abilities required include close vision, color vision, distance vision, peripheral vision, depth perception and the ability to adjust focus; need for 20/20 vision corrected or uncorrected
- Mental Demands: Reading documents and procedures according to GMP standards and regulations. Basic math skills, verbal and written communication skills