Job Title: Manager Filling & Pkg Staff US (2nd Shift)
About the JobThis 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
North America Applicants Only
The salary range for this position is:
$90.000,00 - $130.000,00
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.
