Responsible for executing packaging operations in accordance with clinical study protocol and packaging batch record, package and label clinical supplies ensuring 100% accuracy and reconciliation, meeting the project's scheduled packaging timelines.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Responsible for performing all aspects of packaging/labeling as required, including the completion of pristine documentation.
Documentation of completed steps in batch records for labeling and packaging operations.
Ensures production runs are executed efficiently with high quality and minimal waste.
Participates in Packaging Schedule meeting.
Adheres to SOPs and job specific packaging procedures.
Maintain a safe working environment and report potential hazards.
Ensures the cleanliness of packaging areas is maintained through good housekeeping practices.
Adherence to local Environmental and Safety policies and procedures.
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.
Stationary Position: From 1/2 to 3/4 of the day.
Move, Traverse: Up to 1/4 of the day.
Operate, activate, use, prepare, inspect, or place: 3/4 of the day and up.
Install, place, adjust, apply, measure, use, or signal: Up to 1/4 of the day.
Ascend/Descend or Work Atop:
Position self (to) or Move (about or to): 3/4 of the day and up.
Communicate or exchange information: 3/4 of the day and up.
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 50 pounds between 1/4 and 1/2 of the day.
TABE testing requirements met at approved grade level for position.
Basic Mathematical Skills
Basic Computer Skills: Ability to perform basic computer tasks and has the ability to operate common computer programs.
Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
Intermediate Reasoning: Ability to apply common sense understanding to carry out instructions that may be furnished in written, oral, or diagram form. Ability to deal with problems that involve several concrete variables in standardized situations.
Ability to demonstrate attention to detail.
Ability to hold oneself in a professional manner.
Ability to display excellent time management skills.