Overview

Position Summary:

Performs basic filling and packaging functions in support of Hemostasis product lines as required . Uses automated and manual methods in accordance with established Quality standards and cGMP's.

Responsibilities

Key Accountabilities:

Responsible for filling all products into primary vials.
Loading and unloading Lyophilized products.
Pull prepared material per production schedule.
Performs repeated tasks reconciliation at the end of the order; return and transfer components and document the eDHR.
Ensuring pre/post filling equipment parts are cleaned and sanitized for production runs cleanliness of filling, and lyophilization equipment per equipment.
Maintains all production areas in a clean and orderly manner which is consistent with GMP.
Set up and change-over all the filling lines, perform necessary adjustment, troubleshooting, and preventative maintenance on the filling equipment, including crimping equipment.
Handles basic administrative and semi-skilled work routines.
Manages operation of non-complex technical and/or mechanical tools and equipment.
Demonstrates proficiency of current Good Manufacturing Practices (cGMP) and Good Documentation Practices.
Responsible for completing and maintaining all required company training.
Other responsibilities as assigned by supervisor.

Networking/Key Relationships:

TBD based on departmental needs

Individual Contributor Core Competencies:

Managing Work
Effectively managing one’s time and resources to ensure that work is completed efficiently.

Emotional Intelligence Essentials
Establishing and sustaining trusting relationships by accurately perceiving and interpreting own and others’ emotions and behavior; leveraging insights to effectively manage own responses so that one’s behavior matches one’s values and delivers intended results.

Building Partnerships
Developing and leveraging relationships within and across work groups, including cross-functional groups, to achieve results.

Decision Making
Identifying and understanding problems and opportunities by gathering, analyzing, and interpreting quantitative and qualitative information; choosing the best course of action by establishing clear decision criteria, generating and evaluating alternatives, and making timely decisions; taking action that is consistent with available facts and constraints and optimizes probable consequences.

Continuous Improvement
Originating action to improve existing conditions and processes; identifying improvement opportunities, generating ideas and implementing solutions.

Continuous Learning
Actively identifying new areas for learning; regularly creating and taking advantage of learning opportunities; using newly gained knowledge and skill on the job and learning through their application.

Qualifications

Minimum Knowledge & Experience required for the position:

High School diploma or equivalent with less than or equal to one year experience in a production/manufacturing enviornment.

Skills & Capabilities:

Administrative skills and PC Literate a must, SAP experience a plus.
Must be able to demonstrate ability to communicate work requirements and problems.
Must be able to read, interpret, and perform job duties as prescribed in the Standard Operating Procedures.

The hourly wage range Werfen reasonably expects to pay for the position is $21 to $24. Compensation is reasonably based upon multiple factors including education, relevant experience, skillset, knowledge, and specific needs of the business.

Werfen

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