Supervisor, Visual Inspection

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI.

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

This role is responsible for supervising visual inspection technicians to support daily operations for visual inspection, packaging and labeling of both clinical and commercial products following cGMP’s and in-house SOP’s. The supervisor schedules and supports daily operations for visual inspection technicians, prepare and oversee production activities, and assign personnel tasks in order to meet production schedule demands. They are expected to stay current on industry trends, inform team members of new policies and procedures, and display the highest level of integrity.

This individual to possess strong people skills with the ability to organize, lead, and develop team members and has the ability to delegate tasks. A strong candidate for this position is a value-based leader who is quality driven, people oriented, has the ability to multitask a variety of projects, and works well in a dynamic work environment.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.

• Provides technical support, training, leadership and guidance to all Visual Inspection Technicians

• Oversees areas with the responsibility of examining materials and product for quality and defects

• Early detection, troubleshooting, and escalating of problems which arise on the floor to prevent downtime. Communicates product quality issues to VI Manager and Quality Management.

• Supports Quality System Event investigations (Event Reports / Deviations / CAPAs) by collaborating with employees involved and investigating non-conformities associated to Visual Inspection, Packaging, and Labeling process.

• Responsible for creating and/or revising documents within Master Control (Standard Operating Procedures, Product Specifications, Material Control Procedures)

• Authors or reviews technical protocols to support method development or process validation

• 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

• Increases efficiency and productivity by promoting systems, training, and proper record keeping

• Maintains compliance of company policies, safety standards, quality specifications and regulatory requirements

• Creates and maintains training criteria within Master Control, and performs new employee training

• Supports development and tracking of metrics (KPI’s) relating to defect rate, inspection throughput, on time delivery and right first-time.

• Provides a high level of communication to VI Manager

• On the floor SME for all department-related production equipment

• Development of Visual Inspection team through individual reviews, goals and objectives. Writes annual performance reviews and manages direct reports. Act as trainer and coach for direct reports and support career growth and development and/or job satisfaction.

• Other duties, as assigned, or as business needs required

• Must be able to maintain visual qualifications: (20/20 vision corrected or uncorrected checked annually); ability to see all colors and the ability to visually discern product specifications across multiple products

• Must be able to work while wearing required PPE for all GMP areas for an entire shift. (Includes non-latex gloves, hair eard covers and lab coats)

• Able to communicate effectively and train others

• Able to deal with ambiguity

• Able to translate ideas to actual concepts and processes

• Proven ability to manage multiple projects simultaneously

• Able to follow written…