Manager Filling & Pkg Staff US (2nd Shift)

About the role

This is a 2nd shift position: 2:00pm to 10:00 pm and the candidate must be available to work during weekends and holidays as needed.

Main Responsibilities

• Manages people process within a process/product team to meet goals and priorities.
• Assures those operations are conducted in compliance with regulatory authorities.
• Responsible for the packaging operations of syringes and vials vaccines to meet established requirements.
• Assures 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.
• Performs all other duties as required by department management.
• 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