Supervisor, Visual Inspection

PCI Pharma Services•Madison, WI

About The Position

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. Summary of Objective: 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.

Requirements

+5 years of experience with inspection and manufacturing equipment and processes that comply with regulatory requirements.
Relevant industry experience in sterile product manufacturing or visual inspection (3-5 years) or related experience
Experienced with GMP’s, SOPs and working within an FDA / EU regulated environment.
Experience with eQMS, Master ControlTM is a plus
Experience with Visual Inspection and or labeling and packaging of Pharmaceutical final products, medical device, and/ or combination products a plus
Prior laboratory experience a strong plus
High school diploma or equivalent is required
Proficient with MS Office (Word / Excel / Access)
SME in Visual Inspection of large and small volume parenteral, both Liquid and Lyophilized presentations
Maintains a high level of integrity while balancing all job responsibilities
Ability to coach, train and mentor employees
Strong written and verbal communication skills
Ability to read, understand, follow and comply with technical and written documents (SOPs) in English
Team oriented and highly collaborative
Self-motivated, proactive in identifying product quality issues or employee performance issues
Maintains a high level of integrity while balancing all responsibilities
At ease building rapport with multiple departments to achieve company goals and objectives
Highly attentive and organized with documentation
Strong commitment to excellence and quality with a positive working attitude
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\beard 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 instructions
Able to work as a team
Lifting up to 20 pounds
Sitting for long periods of time >50%
Walking, standing, bending, stooping and kneeling <25% of the time

Nice To Haves

AS/BS degree in related field is highly preferred.

Responsibilities

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