- 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.
- TBD based on departmental needs
- High School diploma or equivalent with less than or equal to one year experience in a production/manufacturing enviornment.
- 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.
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Filling Operator I - Orangeburg, United States - Werfen
Description
OverviewWerfen
Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.
Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We're passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.
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.
ResponsibilitiesKey Accountabilities:
Networking/Key Relationships:
Individual Contributor Core Competencies:
Managing WorkEffectively managing one's time and resources to ensure that work is completed efficiently.
Emotional Intelligence EssentialsEstablishing 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 PartnershipsDeveloping and leveraging relationships within and across work groups, including cross-functional groups, to achieve results.
Decision MakingIdentifying 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 ImprovementOriginating action to improve existing conditions and processes; identifying improvement opportunities, generating ideas and implementing solutions.
Continuous LearningActively 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.
QualificationsMinimum Knowledge & Experience required for the position:
Skills & Capabilities:
If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV.
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 is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact for assistance.
We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 5,000 employees around the world comprise our Werfen team.