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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 is required.
  • Demonstrated ability to manage and plan budgets is required.
  • Demonstrated ability to deliver site-performance improvements using Lean and Six Sigma tools is required.
  • Strong technical, analytical, and problem-solving skills are required.
  • Demonstrated problem-solving and business decision-making ability is required.
  • Strong people-management experience is required.
  • Computer skills, including Microsoft applications, and willingness to learn and use System Application and Products Quality Tracking Systems are required.
  • The role requires standing and walking for extended periods while supervising packaging lines, inspection stations, and the warehouse.
  • The role requires lifting, carrying, pushing, or pulling items up to about 40–50 pounds, with proper ergonomics and lifting aids for heavier loads.
  • The role requires repetitive hand and arm movements and bending, reaching, stooping, or squatting to support line setup, changeovers, and line clearance.
  • Good near and far visual acuity, color discrimination, and depth perception are required to support visual inspection and defect detection; corrected vision is acceptable.
  • Manual dexterity and hand-eye coordination are required to handle small components such as vials, syringes, and needle packs without compromising product integrity.
  • The role requires wearing cleanroom or controlled-area gowning, gloves, safety glasses, hearing protection, and other personal protective equipment for extended periods.
  • The role requires working in temperatures, noise, and lighting conditions typical of pharmaceutical packaging and warehouse operations, including cold storage areas where applicable.
  • The role requires availability for overtime, weekends, or alternate shifts based on production needs.
  • The role requires sustained focus and attention to detail during repetitive inspection and documentation tasks.
  • Sound judgment and analytical problem-solving are required for deviations, investigations, root-cause analysis, and defect trending.
  • The role requires understanding and consistently following current Good Manufacturing Practice, Food and Drug Administration requirements, standard operating procedures, and batch-record documentation practices.
  • The role requires prioritizing and managing multiple tasks in a fast-paced environment, including campaign schedules, line clearance, changeovers, and shift handoffs.
  • The role requires making timely decisions under pressure, including stopping a line, escalating quality concerns, or adjusting resources to meet supply targets.
  • Clear verbal and written communication with operators, quality, engineering, and site leadership is required.
  • The role requires leading, coaching, and developing team members, including inspector qualification and training, while maintaining a fair and constructive team environment.
  • Proficiency in basic data and statistical concepts, such as AQL sampling and defect limits, and systems such as Microsoft Office and electronic quality or manufacturing systems is required.
  • The role requires adaptability to new procedures, technologies, and continuous-improvement initiatives.
  • The role requires maintaining strict cross-contamination and containment controls for penicillin and other beta-lactams, including dedicated areas, air handling, equipment, and controlled material and personnel flow.
  • Employees must follow gowning, personal protective equipment, hygiene, gown or uniform change, and decontamination procedures to prevent penicillin exposure.
  • The role requires supporting occupational-health programs, including medical screening and surveillance, exposure monitoring, and reporting suspected exposure or allergic symptoms.
  • The role requires enforcing line clearance, material segregation, cleaning, and changeover procedures to prevent mix-ups and carryover between lots and campaigns.
  • The role requires ensuring inspection and packaging activities, including defect detection, labeling, and AQL sampling, take place in designated controlled areas with accurate and contemporaneous documentation.
  • Containment breaches, deviations, and safety events must be raised and investigated immediately, with corrective and preventive actions driven to closure.
  • The role requires applying the collective bargaining agreement consistently, including job classifications, seniority, shift bidding, overtime distribution, breaks, and work-assignment rules, and avoiding assignments outside defined classifications.
  • Performance and attendance issues must be handled fairly and consistently using documented facts and following progressive discipline and the grievance process, with Human Resources and Labor Relations support.
  • The role requires building respectful working relationships with union stewards and representatives and addressing concerns early to prevent grievances.
  • Schedule, staffing, and production changes must be communicated clearly and in advance, with the notice and consultation required by the collective bargaining agreement.
  • The role requires balancing supply and quality targets with workforce safety, morale, and engagement, and escalating labor-relations matters to site leadership and Human Resources.
  • Applicants must be authorized to work in the United States by any employer and have permanent U.S. work authorization.

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 each assigned packaging campaign, 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 the inspection and packaging work teams within the division, including the team's people, technical, and financial resources.
  • Coach direct 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 due dates.
  • Sponsor monthly unit meetings and champion unit Zero Defects initiatives covering quality, environment, health and safety, supply, and cost.
  • Represent the organization by providing solutions to difficult issues associated with specific problems.
  • Coordinate, plan, and execute all process changeovers in the assigned multi-product manufacturing facility in accordance with 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-lactam products.
  • Support occupational-health programs, including medical screening and surveillance, exposure monitoring, and reporting of suspected exposure or allergic symptoms.
  • Build respectful, open working relationships with union stewards and representatives and address concerns early to prevent grievances.
  • Communicate schedule, staffing, and production changes clearly and in advance, following collective bargaining agreement notice and consultation requirements.
  • Escalate labor-relations matters to site leadership and Human Resources when needed.

Desired Qualifications

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

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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