Jobs · Management · Pennsylvania

Manager Filling & Pkg Staff US (2nd Shift)

Sanofi · Swiftwater, PA · 4 wk ago
ManagementFull-time

Main Responsibilities

  • Manages people process within a process/product team to meet goals and priorities.
  • Affirms that operations are conducted in compliance with regulatory authorities.
  • Responsible for the packaging operations of syringes and vials vaccines to meet established requirements.
  • Affirms that operations are conducted in compliance with cGMPs, CBER, WHO, EP, and other regulatory bodies.
  • Plans and initiates the overall production schedules, coordinating personnel activities with other Manufacturing staff.
  • Reviews batch records for correctness and completeness.
  • Overall responsibilities include employee selection, training, development, counseling recommendations for cost reductions, profit improvement opportunities, cost control, quality of product, incident investigations, managing departmental capital and operation's budgets.
  • Chief duty involves providing managerial coverage for employees as required during third shift working hours.
  • Additional responsibilities include determining and presenting technical process improvements and communicating issues to appropriate groups (e.g., IOC, PCUs , staff meetings), and working for unit teams.
  • When necessary, coordinates Maintenance, Metrology, and Validation activities with applicable leaders.
  • Takes a role in implementing new equipment and procedures.
  • Deviation management, people development, and Quality Assurance of the Packaging Vaccines manufacturing area are required.

About You

  • Basic Qualifications: Minimum - High School Diploma/GED with 5+ years of experience in a cGMP or similar regulated environment. Preferred - Bachelor's degree with 3+ years of experience in a cGMP or similar regulated environment.
  • Must have previous experience in working with a production department of a pharmaceutical company.
  • The candidate must be able to work overtime and flexible hours, including weekends.

Technical Skills

  • cGMP Compliance
  • Batch Record Review
  • iShift (SAP)
  • Deviation Management
  • Continuous Improvement (Lean/Six Sigma, SMS or related methodologies)

Soft Skills

  • Leadership
  • Cross-functional Collaboration
  • Problem-solving
  • Communication
  • Decision-making

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