JOB SUMMARY
The Supervisor of Visual Inspection reports directly to the Manufacturing Manager Responsible for supervising a team(s) of inspection technicians. Responsible for maintaining timely product inspection, documentation and bulk packing of sterile clinical and commercial products following cGMP's and in-house SOPs.
JOB DUTIES
- Provides technical support, training and leadership to Visual Inspection Technicians
- Creates training modules, and performs new employee training
- Oversees areas with the responsibility of examining materials for quality, defects and planning of work
- Early detection and troubleshooting of problems arising on the line to prevent downtime
- Assist and or performs investigations, and resolves deviations associated to Visual Inspection process
- Manages, creates, plans and maintains metrics relating to defect rate, inspection throughput, and on time and right first time delivery
- Ensures visual inspection process and operator qualification process maintains compliance to applicable regulatory markets
- As needed participates in audits by customer and regulatory bodies as the Visual Inspection SME
- Increase efficiency and productivity by promoting systems, training, and proper record keeping
- Maintains compliance of company policies, safety standards, quality specifications and regulatory requirements
- Development of Visual Inspection team through individual reviews, goals and objectives
EDUCATION, PROFESSIONAL SKILLS, & EXPERIENCE
- AS/BS degree in related field is highly preferred. Relevant experience in sterile product visual inspection 4+ years
- At least 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
- Proficient with MS Office (Word/Excel/Access)
- Work across multiple departments to achieve goals and objectives
- Ability to coach, train and mentor employees
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, hairbeard 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
COMMUNICATIONS & CONTACTS
Primarily interacts with staff in the following departments at all levels: Operations, Quality, Validations, and Facilities.
MANAGERIAL & SUPERVISORY RESPONSIBILITIES
- Manage approximately 10 Direct / Indirect Reports
- Screens and recommends applicants for open positions.
- Makes recommendations for promotions.
- Recommends and or executes appropriate disciplinary action when required