Quality Label Room Technician

PCI Pharma Services•Rockford, IL

103d•Onsite

About The Position

Perform and document quality inspection activities for labels during various stages of clinical trial label creation and production including receiving and releasing of clinical labels, approval of master randomization files and distribution inspections. Manages multiple clinical label orders, with various types of work activity. Performs inspections of individual shipments for clinical distribution including cold chain, ambient and scheduled product.

Requirements

High School Diploma or GED and/or 1-3 years related experience and/or training.
Basic Mathematical Skills
Basic Computer Skills: Ability to perform basic computer tasks and has the ability to operate common computer programs.
Limited Working Proficiency: The ability to satisfy routine social demands and limited work requirements. The ability to read simple prose, in a form equivalent to typescript or printing, on subjects within a familar context.
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.
Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.
Attendance to work is an essential function of this position.

Nice To Haves

Ability to follow instructions and respond to management direction.
Ability to identify and resolve problems in a timely manner.
Ability to work independently and/or as part of a team.
Ability to demonstrate attention to detail.

Responsibilities

Performs receiving, finished goods and distribution inspection as required.
Ensures work is consistent between labeling orders to maintain clinical blinding requirements.
Works effectively in a clinical packaging environment that utilizes serialized kit numbers, where one packaging lot is made up of multiple individual packaging lots.
Manages multiple clinical label orders at the same time.
Completes documentation of paperwork to ensure accuracy and correctness.
Interprets formulas to arrive as specified quality and reliability standards.
May participate on Customer Project/Improvement teams.
Records test data, using quality control procedures.
Inspects and ships samples to customers.
Inspects randomization lists for accuracy.
Works with internal departments to ensure labeling requirements are met.
Supports accurate storage of retain components and or finished goods.
Approval of master randomization files in Prisym.
Approval and release of the marriage of booklet and overlay of labels verifying no unblinding concerns.