Production Specialist

Akorn, Inc. Somerset, NJ
Job Description

SUMMARY:

The Production Specialist is responsible for the overall scheduling of manufacturing at the Somerset Akorn site.

ESSENTIAL FUNCTIONS:

* Interacts with the Corporate and Site planning group to ensure the plant is on target to meet the established plan.

* Schedule the manufacturing of all products/lines to meet the established plan, and publish the schedule in a timely manner.

* Request MBR's needed for production in a timely manner.

* Transact in JDE.

* Assign raw materials to each batch, perform calculations required in the Master Batch Record.

* Interact with other departments as required to assure the release of raw materials and assay data in a timely manner.

* Coordinate resources needed for weighing raw materials to be sent for sterilization.

* Scheduling E-Beam, EtO and Gamma sterilization of components.

* Recognizes and solves problems affecting production schedules.

* Schedule and Coordinate Aseptic Media Simulations.

* Coordinate interdisciplinary discussions related to new product launch.

* Writing, reviewing and/or approving Departmental Standard Operating Procedures, Master Batch Records and Validation Protocols.

* Update, review and approve SOP's bi-annually

* Work with production supervision in identifying gaps in SOP's, Forms and Log Books. Initiate and Champion the project to remediate the gap.

* Work with metrology group to ensure production equipment is calibrated in a timely manner.

* Maintain production metrics and (Key Production Indicator's) KPI's electronically and post data daily.

* Work with R&D department and assist with implementation of new products including the coordination and scheduling of resources.

ADDITIONAL RESPONSIBILITIES

* Interact with supervisors and managers in all departments on all shifts to expedite records and resources to ensure alignment prior to execution.

* Review sterile production documentation forms, log books and batch records.

* Participates in quality investigations

* Participate in special projects as assigned.

Qualifications

ESSENTIAL KNOWLEDGE, SKILLS AND ABILITIES

* Fully trained in cGMP's and compliance requirements

* 3-5 plus years' experience working in a Sterile pharmaceutical manufacturing environment

* Must have scheduling experience

* Must have excellent writing skills

* Must have excellent interpersonal communication skills.

EDUCATION AND EXPERIENCE:

Bachelor's Degree preferred or 5 plus years' experience in cGMP/Pharmaceutical manufacturing process environment