Supervisor, Manufacturing Support (Nights)

KBI Biopharma•Durham, NC

49d•$101,000 - $138,600

About The Position

This position is on a 2-2-3 shift. Night shift schedule is 7pm - 7am A Supervisor in the Manufacturing Support Department will coordinate and supervise, Manufacturing Support operations such as Cleaning of the GMP Facilities, PAR operations, Raw Material Sampling operations and Process Waste Operations. The Supervisor will ensure compliance in all operations that align with all regulatory guidelines, company policies, Standard Operating Procedures (SOP) and Policy Documents (PD). Manufacturing Support Supervisor will supervise and support all Manufacturing Support operations accurately and apply their GMP knowledge and experience to troubleshoot operational issues. This includes facilitating additional support with external departments, such as responses required to maintain and ensure all Manufacturing Departments are operational which may require work schedule adjustments. The supervisor will guide, mentor and coach Manufacturing Support personnel ensuring each associate understands their daily task, performs their task with extreme efficiency, and coaches them to exceed all expectations and gives each associate the tools to become successful. The Supervisor of the Support Department will maintain a sense of ownership of all Support Department operations for his/her shift and ensure the resources are available, resources are coordinated, resources are efficient, and Quality is implemented in all aspects of the Support Department. Will be required to use the Quality System (CAPA, Deviation, Change Control, and Training) to ensure compliance within the Department. The expectation of the Supervisor of the Manufacturing Support Department is to lead by example and to model the KBI Values. It is the duty as a Supervisor to ensure the safety and compliance of each personnel while on KBI property.

Requirements

High School Diploma with 8+ years of relevant manufacturing experience; or Associate Degree with 6 years of relevant manufacturing experience; or Bachelor's Degree with 4 years of relevant manufacturing experience.
2+ years of prior leadership/supervisory experience.
Excellent written and verbal communication skills are required.

Nice To Haves

Knowledge of Quality Assurance systems and regulatory agency guidelines is preferred.

Responsibilities

Support and trains all supervised associates to complete daily task.
Ensures learning and development of departmental associates.
Responsible for and ensures manufacturing compliance with GDP's and cGMP's with logbook and record entries.
Facilitate responsibilities required to support operations.
Communicates with external departments to ensure required task are scheduled and completed.
Initiate Compliance Quality Systems such as Deviations, CAPAs and Change Controls that are related to the Support Department JOB DESCRIPTION T-0094 Rev 0 Job Description Template
Performs/supports annual/biannual performance reviews of direct/indirect reports within the Support department.
Adheres all safety requirements and report unsafe conditions.
Ability to work outside routine schedules to maintain support operations when necessary.
Write/Revise Department SOP's, TRN's, Manufacturing Records
Perform Change Control Assessment related to Support Department functions.
Requires strategic planning and decision making to ensure continual operations while remaining compliant with various policies and procedures.
Reviews and approves direct reports timesheets and PTO request.