Aseptic Fill Finish Team Leader

US-NY-Melville
ID
2017-3457
# of Openings
1
Category
Manufacturing
Type
Direct Hire

Overview

Team Leader is responsible for the compliant execution of the manufacturing process strictly adhering to cGMP; environmental health and safety guidelines; and any other related regulations which could apply. Under the general direction of the manager, this position shall provide strong leadership and will be responsible for the on the floor oversight and hands-on execution of all activities in the production area. The individual in this role will lead a cohesive team responsible for producing high quality medicines on schedule and within quality standards and cost objectives. Primary area of responsibilities are in aseptic filling, parenteral inspection and packaging operations.

Responsibilities

Main Responsibilities

  • Provide on the floor leadership, direction and mentoring to Technicians/Operators/Associates in their respective work environments.
  • Schedules workload for shift and assures a smooth and timely transition between shifts.
  • Initiates and manages deviations to closure including associated CAPAs using six-sigma tools such 5 Whys, Cause and Effect, etc.
  • Conducts and participates in Failure Mode Analysis and Risk Assessments as necessary
  • Ensure all production materials and PPE are present as required
  • Ensures all employees are trained effectively and consistently and comply with cGMP’s and SOPs
  • Develop SOP’s and specifications as required.
  • Aseptic SMEs for the following operations: preparation, filling, inspection, and packaging.
  • Participates and champions operational excellence initiatives such as TPM, OEE tracking.
  • Ensure his/her areas of responsibility are in the highest state of readiness by conducting daily walk-thrus and ensuring deficiencies are documented via the work maintenance – MP2 or SAP.
  • Meet ISO 8 thru ISO 5 gowning requirement
  • Oversee the inventory of components and spare parts using SAP.
  • Provide leadership to ensure a safe work environment. Participate in company-wide safety teams, utilizing safety metrics and goals for improvement. Conducts and participates in accident investigations as necessary.
  • Ensure compliance with all cGMP requirements and all regulations impacting the manufacturing operations
  • Responsible for managing the performance management process of the direct reports including periodic written reviews, coaching, and disciplinary action if required. Manages and resolves conflicts.
  • Participates with outside associations and/or regulatory groups within established guidelines.
  • Develops his/her direct reports to achieve individual and company goals.
  • Participate in hiring as required to maintain appropriate staffing levels in the department.
  • Maintain fiscal responsibility by ensuring that department spending is within budget levels. Provide monthly analysis of expenditures and assists in the preparation of the annual budget;
  • Additional duties as assigned.

Qualifications

Background and Experience:

  • Bachelor's Degree in Science, Engineering, or related field required.
  • Ten (10) years’ experience in a manufacturing environment with a minimum of five (5) years’ in a supervisory role
  • Minimum of 3 years of aseptic processing is preferred
  • Extensive knowledge of Microsoft Office Suite, Microsoft Project and Database management
  • Extensive knowledge of global cGMPs, regulations and validation requirements

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