Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
We are PCI.
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
JOB DESCRIPTION:
Assists with designated execution of customer projects and ongoing order fulfillment to ensure that objectives are accomplished within the prescribed time frame and budget while adhering to applicable pharmaceutical regulations. Supports maintaining exceptional client satisfaction and superior business performance metrics.
Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.
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Create and maintain the customer specific production schedule for both long-term forecast and short-term production demands; follow up on the workflow through each step to maintain schedule integrity and communication.
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Communicate any On-Time Delivery risks.
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Ensure accurate forecasts are in place for monthly Material Requirements Planning runs.
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Understand and interpret application of purchasing authorization from the supply agreement; Place purchase order requisitions with procurement and work with them to expedite, delay or cancel if necessary; ensure on-time delivery and communicate any issues with on-time delivery.
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Support fulfillment and application of Material Requirements Planning tools in ERP system though forecast and order management.
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Maintain an understanding of the document creation process which includes but is not limited to the following: Lot/Expiration form creation, material receipt/release, batch record preparation and ERP work order creation.
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Track On-Time Delivery and document creation metrics for the appropriate business units.
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Manage and monitor purchase order statuses within the PCI-Rockford organization to ensure On-Time Delivery metrics are met Work with the customer to ensure correct components and artwork changes; communicate price variances with management.
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Review and approve documentation including specifications and batch records, as required.
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Create a bill of materials, and component item number and ensure overall data entry accuracy and management.
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Monitor and facilitate timely Releases of finished goods. Assist in the preparation of shipment documents.
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Assist with the disposition of non-conforming materials and Component Variance Notifications.
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Order and ensure shipper labels and print mats are ready for maintenance and production requirements.
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Ensure obsolete materials are dispositioned and invoiced after a component revision or the end of a project.
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Responsible for ensuring the destruction of obsolete materials & expired materials as well as providing the Certificate of Destruction to the customer (as required).
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Work with the Incoming Quality Department to ensure the timely release of components and bulk.
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Allocate and manage lot specific materials to the Work Order.
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Maintain optimal component inventory level for customer owned inventory. Provide continuous support to Project Manager and team for day-to-day internal problem solving and trouble shooting.
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Training and onboarding for new employees within same role, as requested. This position may require overtime and/or weekend work.
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Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.
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Attendance to work is an essential function of this position.
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Performs other duties as assigned by Manager/Supervisor.
Qualifications:
The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Required:
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Associate degree in a related field and/or 1-3 years related experience and/or training.
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College Level Mathematical Skills
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Intermediate Computer Skills: Ability to perform more complex computer tasks and has knowledge of various computer programs.
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Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
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High Reasoning: Ability to solve practical problems and deal with a variety of concrete variables in situations where there is only limited standardization. Ability to interpret a variety of instructions that may be provided in various forms.
Preferred:
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Able to set and achieve challenging goals.
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Ability to adapt to a changing work environment.
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Ability to display excellent time management skills.
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Ability to identify and resolve problems in a timely manner.
Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future
Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
At PCI, Diversity, Equity, and Inclusion (DEI) are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.
What We Do
PCI is a leading provider of integrated pharmaceutical development services to the global healthcare market. With facilities in North America and Europe, PCI supports pharmaceutical and biotech companies with products destined for more than 100 countries around the world. PCI provides services for each stage of the product lifecycle – from early Phase I through commercial launch and long-term supply – and partners with customers to provide key insight and expertise in enabling successful commercialization and bringing lifesaving medications to patients. For more information, go to www.pci.com.
