Commercial Associate Project Manager I

Summary of Objective:

The Commercial Associate Project Manager I assists with designated customer projects to ensure that objectives are accomplished within prescribed time frame and budget while adhering to applicable pharmaceutical regulations.

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.

Essential responsibilities fall into four main areas- Scheduling, Component Management, Production Monitoring, and Shipments

Scheduling

• Facilitate the creation of item number requests for new projects and updates to revisions to existing projects

• Create and route Lot Expiry (LE) forms for assigned projects per the packaging schedule. Ensure routing is successfully completed in time to meet Packet readiness timeline.

• Create scheduling request for each packaging order and deliver to the Scheduling team, schedule requests should be submitted as soon as reasonably possible to meet client demand

• Create Sales Order and Work Order in ERP system (JDE) upon receipt of customer PO.

• Own the packet routing process for assigned clients - providing the Quality team with the requisite amount of time to complete the process and deliver the packet to the Operations Team.

• Communicate required bulk delivery dates to customers to meet packaging demand

• Create and manage Original Promise Date (OPD) in JDE for any required adjustments that impact delivery dates

• Track packet issuance metrics for assigned customers

Component Management

• Monitor purchase order statuses to ensure on-time component delivery

• Maintain optimal component inventory levels to meet packaging orders - understanding component lead times and future forecast. Collaboration with Procurement is required.

• Order and ensure shipper labels and print mats/slugs are ready for maintenance and production requirements

• Responsible for the destruction of obsolete materials & expired materials as well as providing COFD to the customer (as required).

• Ensure obsolete materials are billed for and managed after a component revision or the end of a project once they are ship confirmed

• Collaborate with Central Parts or customer for the ordering of any TempTales

Production Monitoring

• Maintain communication with the Operations team during packaging runs to ensure all needs are met in a timely manner

• Facilitate the creation and routing of Change Orders that are required for packaging.

• Create sample requests as required by customers, ensure the appropriate instructions and documentation are contained for shipping.

Shipments

• Partner with IQA to ensure timely release of components and bulk, ensuring all requirements are available ahead of component delivery

• Facilitate the documents required to transfer material between sites.

• Track releases of Finished Goods for timely shipment

• Prepare and distribute necessary shipping documents to the appropriate team members

Miscellaneous

• Review and approve documentation including specifications and batch records, as required.

• Provide continuous support to Project Manager and team for day-to-day internal problem solving and trouble shooting.

• Training and onboarding for new employees within the same role, as requested.

• This position may require overtime and/or weekend work.

• Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.

• Attendance to work is an essential function of this position

• Performs other duties as assigned by Manager/Supervisor.

Special Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions

• Stationary Position: From 1/4 to 1/2 of the day.

• Move, Traverse: From 1/4 to 1/2 of the day.

• Operate, activate, use, prepare, inspect, or place: Up to 1/4 of the day.

• Install, place, adjust, apply, measure, use, or signal: Up to 1/4 of the day.

• Ascend/Descend or Work Atop: None.

• Position self (to) or Move (about or to): Up to 1/4 of the day.

• Communicate or exchange information: From 1/2 to 3/4 of the day.

• Detect, distinguish, or determine: Up to 1/4 of the day.

• On an average day, the individual can expect to move and/or transport up to 10 pounds

less than 1/4 of the day.

This position may have the following special vision requirements.

Close Vision Distance Vision Color Vision Peripheral Vision Depth Perception

Ability to focus No Special Vision Requirements

Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The following are some environmental conditions that one may be exposed to on a daily basis and for various lengths of time.

• Work is primarily performed at a desk and/or in an office environment. for 3/4 of the day and up.

The noise level in the work environment is typically, quiet.

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:

• Associate degree in a related field and/or 1-3 years related experience and/or training (project coordinator, business analyst, etc.).

• College Level Mathematical Skills

• Intermediate Computer Skills: Ability to perform more complex computer tasks and has knowledge of various computer programs.

• Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.

• Very High Reasoning: Ability to define problems, collect data, establish facts, and draw valid conclusions. Be able to interpret an extensive variety of technical instructions in math or diagram form and deal with several abstract/concrete variables.

Preferred:

• Able to set and achieve challenging goals.

• Ability to adapt to a changing work environment.

• Ability to display excellent time management skills.

• Ability to identify and resolve problems in a timely manner.

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