Manufacturing Superintendent

DUTIES AND RESPONSIBILITIES

This position is responsible for the general supervision of all clean room activities involving FFS Machines and Formulations. This position will supervise a 12-hour night shift.

* Supervises formulation and filling operations for multi-line Form-Fill-Seal (FFS) machines in compliance with FDA guidelines.
* Responsible for managing all FFS Machine and Clean Room operations to achieve optimal quality and quantity of output.
* Supervises a large number of non-exempt employees with widely varying job responsibilities including the operation of highly complex FFS machinery and supporting laboratory and manufacturing equipment. Duties include a large number of candidate interview, performance review, time and attendance records.
* Directly responsible for ensuring product is manufactured under cGMP compliance, following an extensive set of established standards and guidelines.
* Responsible for providing and maintaining training under cGMP compliance. Duties include presentations at training sessions, updating employee training records, timely and accurate training sessions, updating and performing a four-step skill block-training program for FFS Operators.
* Responsible for the review and approval of all documentation performed under cGMP guidelines in a timely manner. Directly responsible for product flow throughout the manufacturing process as it pertains to batch investigation and release. Responsible for identifying deviations to aseptic manufacturing process and taking appropriate corrective action.
* Directs and Coordinates resources to perform non-routine manufacturing activities as required by QC Micro, QC Chemistry, QA Maintenance and R&D departments.
* Prepares and maintains various logs, reports, and records for senior management.
* Reviews training on appropriate procedures, policies and practices.
* Participates in Dey's safety program.
* Assumes plant responsibility in the absence of Shift Superintendent during off hours.

REQUIRED EDUCATION/EXPERIENCE/SKILLS

* High school Diploma or equivalent (GED) preferred.
* Two year college degree preferred.
* Three to five years experience in the pharmaceutical or food/beverage industries.
* Good verbal and written communication skills.
* Good interpersonal/group skills with ability to direct others.
* Knowledge of pharmaceutical industry, MOPs, GPPs, QAOPs, LTs, GPMPs, cGMPs, and internal policies and procedures
* Computer literate (word processor spreadsheet.
* Prior supervisory experience in a fast-paced, multiple priority environment preferred.

DEY supports diversity in the work place. We are an Equal Opportunity Employer.