This is a 2nd shift position (3 PM – 11:30 PM) - Monday- Friday, covering Saturday's or Sunday's on a rotating schedule including rotating holidays.Management experiencePOSITION OVERVIEW:This position will be an off-shift position. Applicants must be able to work 2nd shift hours, weekends, and holidays.KEY 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, Management Committee, 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.
BASIC QUALIFICATIONS:
HS/GED with 5 years' experience in a cGMP or similar environment
Must have previous experience in working with a production department of a pharmaceutical company. Working knowledge of cGMPs.
Must have knowledge of continuous improvement techniques and problem-solving skills.
Excellent verbal and written communication skills. Working knowledge of SAP is preferred.
The candidate must be able to work overtime and flexible hours, including weekends.
PREFERRED QUALIFICATIONS:
BS in Life Sciences or similar preferred
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