Quality Label Room Technician

Job Title: Quality Label Room Technician

Department/Group: Clinical QC

Location: Logistics

Summary of Objective:

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.

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.

• 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.
• 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. Approval of master randomization files in Prisym.
• Approval and release of the marriage of booklet and overlay of labels verifying no unblinding concerns.

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:

• 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.

• Other Required Skills.

Preferred:

• 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.

The hiring rate for this position is $16.50 - $18.57 plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k).

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