• 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. 

• Works overtime as required.

Requirements

• BS/BA degree in life sciences or engineering discipline preferred (work experience in lieu of a degree is possible)

• Previous supervisory experience in a production/manufacturing environment.

• Proven oral and written communication and proofreading skills required.

• Detail oriented and proficient computer skills: d Microsoft Office software, including Excel, Word, and Access preferred.

• Previous experience in an FDA regulated industry preferred (3-5 years).