Inspection/Packaging Line Leader (2nd Shift)

Pfizer • Rochester, MI

1d • Onsite

About The Position

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 cGMP and FDA requirements, and develop Cost Improvement Projects. Lead the inspection and packaging work teams within the division, including their people, technical, and financial resources. Coach team members on visual inspection, defect classification, inspector qualification, and documentation practices. Solve complex problems in the area of expertise and support deviations, investigations, and process improvements on the packaging line.

Manage multiple projects and ongoing team activities, monitor subordinate colleagues’ efforts toward short-term goals, and schedule staffing to meet customer needs and production schedules within budget guidelines. Facilitate regulatory and customer audit tours, conduct operational quality, environmental, and safety incident investigations, provide audit responses, and implement corrective actions by their due dates. Sponsor monthly unit meetings and champion Zero Defects initiatives across quality, environment, health and safety, supply, and cost. Coordinate, plan, and execute process changeovers in an assigned multi-product manufacturing facility while maintaining high safety and quality standards. Work within established HR policies, support colleague development through timely feedback and appraisal, and apply functional knowledge and Pfizer-specific principles and practices to improve operations.

The role is based in a controlled manufacturing environment and combines hands-on floor presence with compliance-driven work. It operates in a penicillin (beta-lactam) manufacturing facility with a unionized workforce. The Team Leader is responsible for strict containment and cross-contamination controls, employee safety, and applying the collective bargaining agreement (CBA) and site labor-relations practices consistently. The position is on premise and may require overtime, weekends, or alternate shifts according to production needs.

Requirements

• One of the following education and experience combinations: bachelor’s degree and at least 2 years of experience; master’s degree and 0 or more years of experience; associate 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 deliver site-performance improvements using Lean and Six Sigma tools.
• Strong technical, analytical, and problem-solving skills.
• Demonstrated problem-solving and business decision-making abilities.
• Ability to interact with outside organizations and customers.
• Strong people-management experience.
• Strong interpersonal and communication skills to guide and support team growth and development.
• 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, typically most of a shift.
• Ability to lift, carry, push, or pull items weighing 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 during line setup, changeovers, and line clearance.
• Good near and far visual acuity, color discrimination, and depth perception for 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 PPE for extended periods.
• Ability to work in pharmaceutical packaging and warehouse conditions, including applicable cold-storage areas and typical temperature, noise, and lighting conditions.
• Ability to work overtime, weekends, or alternate shifts based on production needs.
• Ability to sustain 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 cGMP, FDA requirements, SOPs, and good documentation practices for batch records.
• Ability to prioritize 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, such as AQL sampling and defect limits, and proficiency with MS Office and electronic quality or manufacturing systems.
• Ability to adapt to changing procedures, technologies, and continuous-improvement initiatives.
• Ability to maintain strict containment and cross-contamination controls in a penicillin (beta-lactam) manufacturing facility and follow required gowning, PPE, hygiene, uniform-change, and decontamination procedures.
• Ability to apply CBA requirements and site labor-relations practices consistently, including fair handling of performance and attendance issues.

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 packaging campaigns are executed with attention to safety, quality, supply, and cost.
• Maintain line clearance, inspection and packaging procedures, defect detection, and AQL sampling in compliance with cGMP and FDA requirements.
• Develop Cost Improvement Projects and lead initiatives to improve site performance.
• Lead the inspection and packaging teams and manage their people, technical, and financial resources.
• Coach team members on visual inspection, defect classification, inspector qualification, and documentation practices.
• Resolve complex problems and support deviations, investigations, and packaging-line process improvements.
• Manage multiple projects and ongoing work activities and monitor subordinate colleagues’ progress toward short-term goals.
• Schedule staffing to meet customer needs and production schedules within budget guidelines.
• Facilitate regulatory and customer audit tours; investigate operational quality, environmental, and safety incidents.
• Provide audit responses and implement corrective actions by their due dates.
• Sponsor monthly unit meetings and champion Zero Defects initiatives for quality, environment, health and safety, supply, and cost.
• Represent the organization in resolving difficult issues associated with specific problems.
• Coordinate, plan, and execute process changeovers in the assigned multi-product manufacturing facility.
• Operate within established HR policies and guidelines and support colleague development with timely performance feedback and appraisal.
• Maintain penicillin containment and cross-contamination controls, including separation of beta-lactam and non-penicillin products and compliance with designated-area, equipment, air-handling, and personnel/material-flow controls.
• Support occupational health programs, including medical screening and surveillance, exposure monitoring, and reporting suspected exposure or allergic symptoms.
• Enforce material segregation, cleaning, changeover, and line-clearance procedures to prevent mix-ups and carryover.
• Ensure inspection and packaging activities, including labeling and AQL sampling, are performed in designated controlled areas with accurate, contemporaneous documentation.
• Escalate and investigate containment breaches, deviations, and safety events, and drive corrective and preventive actions to closure.
• Apply the CBA consistently to job classifications, seniority, shift bidding, overtime distribution, breaks, and work assignments; address performance and attendance matters fairly and in accordance with applicable processes.
• Build respectful working relationships with union stewards and representatives, communicate staffing and production changes as required, and escalate labor-relations matters when needed.
• Balance supply and quality targets with workforce safety, morale, and engagement.

Benefits

• 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution.
• Paid vacation, holidays, and personal days.
• Paid caregiver, parental, and medical leave.
• Medical, prescription drug, dental, and vision coverage.
• Eligibility for Pfizer’s Global Performance Plan, with a bonus target of 10% 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