Manufacturing Technician IV, Lead - Inspection (PFS 2 Nights

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Reports to a Supervisor/Manager on the Manufacturing floor and leads Inspection floor activities. The Lead serves as the first-line team resource, manages batch record review, oversees team qualification status, and drives continuous improvement in partnership with Process Facilitators and Engineers.

• Lead and monitor process execution activities to ensure successful operations on the production floor.
• Perform inspection activities as needed to support floor coverage and qualification maintenance.
• Perform inventory control and reconciliation activities using SAP and WES.
• Execute protocols as required as part of equipment qualification and process validation work.
• Ensure work requirements are followed on the production floor in accordance with SOPs and cGMPs.

• Manage batch records and GMP documentation on the production floor; review documentation completed by Tech II and III team members.
• Access and print SOPs and forms via ECMS as required; ensure team adherence to current revisions.
• Follow and reinforce job-related safety procedures including PPE use, LOTO, ergonomics, and chemical handling.
• Use process documents including SOPs, forms, and batch records to guide work and ensure requirements are followed on the production floor, in accordance with SOPs and cGMPs.
• Support lean activities including 5S, problem-solving, and serving as CI project resource for the PET.

• Maintain all required certifications and qualifications for the assigned work area.
• Act as first-line resource for the team; provide support to production and mechanical technicians.
• Act as certified OJT trainer on assigned equipment and process tasks; train and evaluate team members.
• Oversee and maintain team qualification and certification status.
• Work alongside Process Facilitators and Engineers to create a collaborative environment for all operators.
• Apply first-line management skills including situational leadership and daily operational decision-making.
• Support deviation investigations, CAPA execution, and SOP revisions as the inspection floor SME.
• Attend and actively participate in daily Tier 1 meetings.

• Demonstrated expertise across all inspection types and equipment, with prior experience leading floor execution in a pharmaceutical or regulated manufacturing environment.
• Significant experience in a pharmaceutical or regulated manufacturing environment.
• Advanced knowledge of cGMP requirements, inspection processes, documentation practices, and investigation support.
• Mastery of visual defect detection and inspection accuracy across all material types handled on the floor.
• Demonstrated leadership experience including coordinating team activities, providing direction, and supporting daily production operations.
• Proven ability to review, approve, and ensure accuracy of critical GMP documentation and batch records.
• Strong organizational, analytical, and problem-solving skills with the ability to coordinate personnel and prioritize operations.
• Experience training, coaching, and developing team members while fostering a culture of compliance and continuous improvement.
• Ability to effectively read, write, speak, and understand English to communicate technical information and lead cross-functional discussions.
• Ability to work effectively as part of a team in a fast-paced production environment.
• Ability to work overtime as needed.
• Ability to pass eye exam during onboarding.

• High school graduate, vocational school graduate, or equivalent.
• 4+ years of experience in a pharmaceutical or regulated manufacturing environment.
• Prior inspection experience.
• Prior supervisory or team leadership experience.
• Experience in metrics tracking and reporting.
• Experience leading inspection process improvements, deviation investigations, and qualification programs.
• Working knowledge of Microsoft applications, SAP and/or Veeva Vault.

This role is primarily a non-Sedentary role. This can include climbing, kneeling, repetitive motion, temperature changes, and exerting up to 100 pounds of force to move objects. Visual acuity such as working with data & figures, viewing computer terminal, extensive reading, operating machinery, operating motor vehicles, general observations of facilities, etc. Participation in an occupational health program, which can include medical assessment, surveillance, vaccination, and testing.

Use of personal protective equipment, which can include respirators, Personal Air…