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Pfizer

Makes cancer drugs, vaccines and other medicines

Inspection/Packaging Line Leader

Machine & Process OperationConfirmed live in the last 24 hours
Full-timeRochester, MI, USA

About the Job

Requirements

  • A bachelor's degree with at least 2 years of experience, a master's degree with 0 or more years of experience, an associate's degree with 6 years of experience, or a high school diploma or equivalent with 8 years of relevant experience.
  • Demonstrated ability to manage and plan budgets.
  • Demonstrated ability to deliver site performance improvements using Lean and Six Sigma tools.
  • Strong technical, analytical, and problem-solving skills, including problem solving and business decision-making.
  • People management experience and the ability to provide guidance and support that enables teams to grow and develop.
  • Computer skills, including Microsoft applications and willingness to learn and use System Application and Products quality tracking systems.
  • Ability to stand and walk for extended periods while supervising packaging lines, inspection stations, and the warehouse.
  • Ability to lift, carry, push, or pull items up to approximately 40–50 pounds, using proper ergonomics and lifting aids for heavier loads.
  • Ability to perform repetitive hand and arm movements and bend, reach, stoop, or squat while supporting line setup, changeovers, and line clearance.
  • Good near and far visual acuity, color discrimination, and depth perception to support visual inspection and defect detection; corrected vision is acceptable.
  • Manual dexterity and hand-eye coordination to handle small components such as vials, syringes, and needle packs without compromising product integrity.
  • Ability to wear required cleanroom or controlled-area gowning, gloves, safety glasses, hearing protection, and other personal protective equipment for extended periods.
  • Ability to work in typical pharmaceutical packaging and warehouse conditions, including temperature, noise, lighting, and applicable cold-storage environments.
  • Ability to work overtime, weekends, or alternate shifts based on production needs.
  • Ability to sustain focus and attention to detail during repetitive inspection and documentation tasks.
  • Ability to apply sound judgment and analytical problem-solving to deviations, investigations, root cause analysis, and defect trending.
  • Ability to understand and consistently follow current Good Manufacturing Practice, Food and Drug Administration requirements, standard operating procedures, and batch record documentation practices.
  • Ability to prioritize and manage multiple tasks in a fast-paced environment, including campaign schedules, line clearance, changeovers, and shift handoffs.
  • Ability to make timely decisions under pressure, including stopping a line, escalating quality concerns, or adjusting resources to meet supply targets.
  • Ability to communicate clearly, verbally and in writing, with operators, quality, engineering, and site leadership.
  • Ability to lead, coach, and develop team members, including inspector qualification and training, while maintaining a fair and constructive team environment.
  • Ability to use basic data and statistical concepts, including AQL sampling and defect limits, and proficiency with Microsoft Office and electronic quality or manufacturing systems.
  • Ability to adapt to new procedures, technologies, and continuous improvement initiatives.
  • Ability to maintain strict cross-contamination and containment controls separating penicillin and other beta-lactams from non-penicillin products, including dedicated areas, air handling, equipment, and controlled material and personnel flow.
  • Ability to follow gowning, personal protective equipment, hygiene, uniform-change, and decontamination procedures to prevent penicillin exposure and sensitization reactions.
  • Ability to support occupational health programs, including medical screening and surveillance, exposure monitoring, and reporting suspected exposure or allergic symptoms.
  • Ability to enforce line clearance, material segregation, cleaning, and changeover procedures to prevent mix-ups and carryover between lots and campaigns.
  • Ability to ensure inspection and packaging work, including defect detection, labeling, and AQL sampling, is performed in designated controlled areas with accurate, contemporaneous documentation.
  • Ability to promptly raise and investigate containment breaches, deviations, or safety events and drive corrective and preventive actions to closure.
  • Ability to apply the collective bargaining agreement consistently, including job classifications, seniority, shift bidding, overtime distribution, breaks, and work assignment rules, and avoid assigning work outside defined classifications.
  • Ability to handle performance and attendance issues fairly and consistently, with documented facts, following progressive discipline and grievance processes with Human Resources and Labor Relations support.
  • Ability to build respectful working relationships with union stewards and representatives and address concerns early to prevent grievances.
  • Ability to communicate schedule, staffing, and production changes clearly and in advance, with required notice and consultation under the collective bargaining agreement.
  • Ability to balance supply and quality targets with workforce safety, morale, and engagement, and escalate labor-relations matters to site leadership and Human Resources.
  • Must be authorized to work in the United States by any employer and have permanent work authorization in the United States.

Responsibilities

  • Coordinate inspection and packaging operations for sterile pharmaceutical products and provide technical support to inspection and packaging teams to sustain and improve processes.
  • Ensure flawless execution throughout assigned packaging campaigns, focusing on safety, quality, supply, and cost.
  • Maintain line clearance, inspection and packaging procedures, defect detection, and AQL sampling in compliance with current Good Manufacturing Practice and Food and Drug Administration requirements.
  • Develop cost improvement projects.
  • Lead inspection and packaging work teams, including the people, technical, and financial resources of the team.
  • Coach reports on day-to-day inspection and packaging activities, including visual inspection, defect classification, inspector qualification, and documentation practices.
  • Solve complex problems within the area of expertise and support deviations, investigations, and process improvements on the packaging line.
  • Manage multiple projects and ongoing work activities within a team.
  • Monitor and manage subordinate colleagues' efforts to achieve short-term goals.
  • Schedule staffing to meet customer needs and schedule attainment within budget guidelines.
  • Facilitate regulatory and customer audit tours and complete operational quality, environmental, and safety incident investigations.
  • Provide audit responses and implement corrective actions by their due dates.
  • Sponsor monthly unit meetings and champion unit Zero Defects initiatives covering quality, environment, health and safety, supply, and cost.
  • Represent the organization in providing solutions to difficult issues associated with specific problems.
  • Coordinate, plan, and execute process changeovers in the assigned multi-product manufacturing facility while maintaining high safety and quality standards.
  • Operate within established Human Resources policies and guidelines.
  • Engage in colleague development, including timely performance feedback and appraisal.
  • Use functional knowledge and Pfizer-specific principles, theories, concepts, and practices to improve operations.
  • Maintain strict cross-contamination and containment controls for penicillin and other beta-lactams, including separation from non-penicillin products.
  • Support occupational health screening, surveillance, exposure monitoring, and reporting of suspected exposures or allergic symptoms.
  • Ensure inspection and packaging activities are conducted in designated controlled areas with accurate documentation.
  • Raise and investigate containment breaches, deviations, or safety events promptly and drive corrective and preventive actions to closure.
  • Apply collective bargaining agreement rules for job classifications, seniority, shift bidding, overtime, breaks, and work assignments.
  • Handle performance and attendance matters through fair, documented processes, including progressive discipline and grievances, with Human Resources and Labor Relations support.
  • Build working relationships with union representatives and address concerns early.
  • Communicate schedule, staffing, and production changes in advance in accordance with collective bargaining agreement requirements.
  • Coach and develop employees, including inspector qualification and training, using fair and transparent criteria and accurate training records.
  • Balance supply and quality goals with workforce safety, morale, and engagement, and escalate labor-relations issues to site leadership and Human Resources.

Desired Qualifications

  • Relevant pharmaceutical industry experience.
  • Previous experience in a Good Manufacturing Practice manufacturing environment.
  • Familiarity and experience with mammalian cell culture, protein purification, or solution formulation.

About the Company

Pfizer

Makes cancer drugs, vaccines and other medicines

Pfizer discovers, makes, and sells prescription medicines and vaccines for patients, doctors, and governments worldwide, with large businesses in vaccines, cancer, heart disease, and rare diseases. In 2020, its COVID-19 shot, developed with German partner BioNTech, became the first COVID-19 vaccine authorized in the United States. Its scientists find drug candidates and run clinical trials to prove they are safe and effective, and Pfizer then manufactures approved products in its own plants, earning most of its money from patented drugs before cheaper generic copies arrive. Pfizer was founded in 1849 as a chemicals business in Brooklyn and is based in New York City.

Company size
10,001+
Company stage
IPO
Headquarters
New York City, New York
Founded
1849

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