Responsible for the supervision and coordination of liquid production personnel and processes within an assigned area of responsibility.  Control may include but is not limited to; scheduling and organizing component preparation, Aseptic and Terminally Sterilized filling, and capping, Lyophilization processing.  Supervises production personnel and compliance with all company and regulatory requirements. Must be flexible to work assigned shifts while allowing for the coverage of vacations and operational gaps in staffing.

Responsibilities (including, but not limited to):

• Coordinates the execution of the daily/weekly production schedule based upon direction from the area production managers. Oversees the production processes on their assigned shift, working on the production floor to coordinate all relevant production activities.

• Interacts with department management and other functional areas to coordinate all support activities relating to their assigned area.

• Empowers assigned personnel to engage in defining and recommending continuous process improvements,

• Completes thorough deviation investigations in a timely fashion, performing detailed root cause analysis and implementing corrective and preventative actions.

• Assures the compliant application of departmental and company policies and procedures, safety programs, standards and cGMP’s.

• Coordinates staffing for their assigned area of responsibility and assures personnel training is up to date.  Develops and executes training and follow-up programs to enhance staff development. Regularly evaluates performance of operations personnel.

• Establishes effective communication methods to provide continuity of information across all operations and shifts.

• Supports product release through the efficient review and completion of production batch records.

• Creates, revises and reviews departmental Standard Operating Procedures.

• Provides production data to managers in support of monthly reports and line efficiency tracking.

• Assumes other duties as assigned by production management.

• All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities.

Requirements:

• Bachelors degree and/or relevant work experience required

• Minimum of five years experience in a production/manufacturing environment; with at least two years in a leadership role

• Experience in a FDA-regulated industry strongly preferred