Inspection/Packaging Line Leader

Pfizer • Rochester, MI

1d • $82,700 - $137,900 • Onsite

About The Position

The Inspection/Packaging Line Leader coordinates inspection and packaging operations for sterile pharmaceutical products and provides technical support to teams to sustain and improve these processes. The role is accountable for flawless execution of assigned packaging campaigns, with a focus on safety, quality, supply, and cost. This includes line clearance, inspection and packaging procedures, defect detection, and AQL sampling in compliance with cGMP and FDA requirements, as well as developing Cost Improvement Projects.

As a team leader, this role leads inspection and packaging work teams and manages their people, technical, and financial resources. The leader coaches team members on visual inspection, defect classification, inspector qualification, and documentation practices; resolves complex issues; and supports deviations, investigations, and packaging-line improvements. The role also coordinates process changeovers in a multi-product manufacturing facility and supports audit readiness, corrective actions, colleague development, and operational performance.

The position is based in a controlled manufacturing environment at a penicillin (beta-lactam) facility with a unionized workforce. It requires strict containment and cross-contamination controls, compliance with the applicable collective bargaining agreement and labor-relations practices, and hands-on presence across packaging lines, inspection stations, and warehouse areas. The work may involve extended standing and walking, lifting and handling materials, repetitive hand and arm movements, cleanroom gowning and PPE, and work in conditions typical of pharmaceutical packaging and warehouse operations, including cold storage where applicable. Overtime, weekends, or alternate shifts may be needed based on production requirements.

Requirements

• Bachelor’s degree and at least 2 years of experience; or master’s degree and 0 or more years of experience; or associate’s degree and 6 years of experience; or high school diploma (or equivalent) and 8 years of relevant experience.
• Demonstrated ability to manage and plan budgets.
• Demonstrated ability to improve site performance using Lean and Six Sigma tools.
• Strong technical, analytical, and problem-solving skills.
• Demonstrated problem-solving and business decision-making ability.
• Experience engaging with outside organizations and customers.
• Strong people-management experience.
• Strong people and communication skills to guide and support teams and help team members 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 production and warehouse areas.
• Ability to lift, carry, push, or pull items weighing about 40–50 pounds, using appropriate ergonomics and lifting aids for heavier loads.
• Ability to perform repetitive hand and arm movements and bend, reach, stoop, or squat when supporting line setup, changeovers, and line clearance.
• Good near and far visual acuity, color discrimination, and depth perception; 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 PPE for extended periods.
• Ability to work in temperature, noise, and lighting conditions typical of pharmaceutical packaging and warehouse operations, including cold storage areas where applicable.
• 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 work.
• Ability to apply sound judgment and analytical problem-solving to deviations, investigations, root cause analysis, and defect trending.
• Ability to understand and consistently follow cGMP, FDA requirements, SOPs, and good documentation practices for batch records.
• 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.
• Clear verbal and written communication skills for working 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 MS Office and electronic quality or manufacturing systems.
• Ability to adapt to new procedures, technologies, and continuous improvement initiatives.
• Ability to maintain strict containment and cross-contamination controls in a penicillin (beta-lactam) manufacturing facility.
• Ability to apply the collective bargaining agreement and site labor-relations practices consistently and fairly.
• Must be authorized to work in the United States by any employer; U.S. work visa sponsorship is not available.
• Permanent U.S. work authorization is required.

Nice To Haves

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

Responsibilities

• Coordinate inspection and packaging operations for sterile pharmaceutical products and provide technical support to sustain and improve processes.
• Ensure assigned packaging campaigns are executed safely and in compliance with quality, supply, cost, cGMP, and FDA requirements.
• Maintain line clearance, inspection and packaging procedures, defect detection, and AQL sampling practices.
• Develop Cost Improvement Projects and contribute to site performance improvements using Lean and Six Sigma tools.
• Lead inspection and packaging teams and manage team people, technical, and financial resources.
• Coach team members on visual inspection, defect classification, inspector qualification, and documentation practices.
• Resolve complex issues within the area of expertise and support deviations, investigations, root cause analysis, and process improvements.
• Manage multiple projects and ongoing team activities, and monitor subordinate colleagues’ efforts toward short-term goals.
• Schedule staffing to meet customer needs and production schedule attainment within budget guidelines.
• Facilitate regulatory and customer audit tours; 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 for quality, environment, health and safety, supply, and cost.
• Represent the organization in developing solutions to difficult issues.
• Coordinate, plan, and execute process changeovers in the assigned multi-product manufacturing facility while maintaining safety and quality standards.
• Operate within established HR policies and guidelines; provide timely performance feedback and appraisals and support colleague development.
• Maintain strict penicillin containment and cross-contamination controls, including product segregation and controlled material and personnel flows.
• Follow and enforce gowning, PPE, hygiene, gown/uniform change, decontamination, line clearance, material segregation, cleaning, and changeover procedures.
• Support occupational health programs, exposure monitoring, medical screening and surveillance, and reporting of suspected exposure or allergic symptoms.
• Ensure packaging and inspection activities occur in designated controlled areas with accurate, contemporaneous documentation.
• Escalate and investigate containment breaches, deviations, or safety events promptly and drive corrective and preventive actions to closure.
• Apply the collective bargaining agreement consistently, including job classifications, seniority, shift bidding, overtime distribution, breaks, and work assignment rules.
• Handle performance and attendance matters fairly and consistently, following documented processes and involving HR and Labor Relations as appropriate.
• Build respectful relationships with union stewards and representatives, communicate schedule and staffing changes as required, and escalate labor-relations matters when needed.
• Balance supply and quality targets with employee safety, morale, and engagement.

Benefits

• 401(k) plan with Pfizer matching contributions and an additional Pfizer Retirement Savings Contribution.
• Paid vacation, holiday, and personal days.
• Paid caregiver, parental, and medical leave.
• Medical, prescription drug, dental, and vision coverage.
• Eligible to participate in Pfizer’s Global Performance Plan, with a bonus target of 10.0% of base salary.
• Relocation support may be available based on business needs and/or eligibility.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager