Visual Inspection Lead - M to F 4PM to 12:30 AM

PCI Pharma Services•Bedford, NH

13d

About The Position

The Visual Inspection Lead performs 100% manual visual inspection, labeling, and packaging of sterile filled containers (vials) in accordance with applicable procedures, regulations, and safety directives across multiple sites. The Lead supports Visual Inspection, Packaging, and Labeling activities with minimal to no supervision and ensures work is completed accurately, in compliance with GMP standards, and within product timelines. The role provides day-to-day leadership to the Visual Inspection team, including organizing and delegating responsibilities, supporting daily assignments, clarifying procedures, training employees, and promoting communication between workers and management. The Lead monitors production activities for adherence to safety and ethics procedures, escalates product-quality issues in real time, and works with management to resolve issues and improve processes. The position also supports quality investigations, document changes, manufacturing records, protocols, performance metrics, qualification test kits, and other projects. Travel between facilities is expected.

Requirements

High school diploma or equivalent.
3–5 years of experience with inspection and manufacturing equipment and processes that comply with regulatory requirements; relevant experience in sterile product manufacturing or visual inspection, or related experience.
Experience with GMPs, SOPs, and work in an FDA- and EU-regulated environment.
Ability to maintain visual qualifications: corrected or uncorrected 20/20 vision checked annually, ability to see all colors, and ability to visually discern product specifications across multiple products.
Ability to work while wearing required PPE for an entire shift in GMP areas, including non-latex gloves, hair/beard covers, and lab coats.
Ability to communicate effectively and train others.
Ability to deal with ambiguity and translate ideas into concepts and processes.
Ability to follow written instructions and work as part of a team.
Ability to read, understand, follow, and comply with technical and written documents, including SOPs, in English.
Team-oriented and highly collaborative approach.
Strong initiative for quality-driven results and commitment to excellence and quality.
High integrity while balancing responsibilities.
Ability to work with multiple departments to achieve company goals and objectives.
Strong attention to detail and organization, particularly with documentation.
Proficiency with Microsoft Office (Word, Excel, and Access).
Ability to understand visual inspection concepts, methodologies, and regulations.
Ability to recognize and communicate quality issues to multiple groups.
Ability to motivate and train less experienced staff.
Exceptional verbal and written communication skills.
Excellent math skills.

Nice To Haves

Experience with visual inspection and/or labeling and packaging of pharmaceutical final products, medical devices, and/or combination products.
Prior laboratory experience.

Responsibilities

Perform 100% manual visual inspection, labeling, and packaging of sterile filled vials in compliance with applicable procedures, regulations, and safety directives.
Support Visual Inspection, Packaging, and Labeling activities across multiple sites with minimal to no supervision.
Follow written procedures and document results neatly and precisely according to GMP standards and other regulations.
Monitor workers during production activities to ensure adherence to ethics and safety procedures.
Motivate workers to improve production quantity while maintaining high production standards.
Collaborate with management to create worker schedules within process capabilities.
Initiate Quality System Event investigations, including Event Reports, Deviations, and CAPAs, and work with management to determine probable root causes.
Perform document changes within the Master Control system.
Review protocols and manufacturing batch records and provide insight for process improvements.
Support development and tracking of KPIs relating to defect rate, inspection throughput, on-time delivery, and right-first-time performance.
Train new employees on visual inspection requirements for liquid and lyophilized final vial products.
Support management in developing and maintaining visual inspection qualification test kits, as applicable.
Assist management with timely execution of protocols and additional projects.
Lead by example, stay current on industry trends, and inform team members of new policies or procedures.
Facilitate communication between workers and management, answer questions, offer guidance, and organize responsibilities.
Identify potential issues using knowledge and experience and work with management to resolve them.
Support team members’ performance toward group objectives while maintaining attention to detail and quality across multiple or repetitive tasks.
Support daily assignments and clarify tasks for the Visual Inspection Team.
Escalate product-quality issues to Visual Inspection Management in real time.
Interact with Operations, Quality, Validations, Facilities, and other departments as required.
Travel between facilities to carry out duties.
Perform other duties as assigned or as business needs require.