• Consulting
  • Lake Forest
  • Close: 2019-05-30

Description:


ANNUAL PRODUCT REVIEW COORDINATOR

Rates are able to be modified to fit the following model, mark-up is unchanged.

Pay range: $25.24/hour-$33.80/hour

Please ensure rates are commensurate with experience level.

DESCRIPTION:

This is a temporary backfill position through the end of 2019 (with the potential option to hire full-time following year's end depending on business need and candidate's performance). This role is primarily responsible for data collection and analysis for the Quality Control laboratories and operational support areas (e.g. complaints, investigations, etc.) to identify negative and eroding trends as well as potential compliance gaps with respect to analytical methods, operations, and components of the Quality Management System (QMS). The candidate will be responsible for working with and guiding supported teams in completing Annual Product Reviews in compliance with PharMEDium’s Standard Operating Procedure.

RESPONSIBILITIES:

-Research, compile, analyze, and summarize large quantities of data from numerous sources. Some sources of data will be paper based, and some sources will be electronic.

-Interact extensively with varied departments (local and remote) to collect the data

-Review technical and Quality documentation and perform trend analysis

-Make recommendations based on data collected and conclusions drawn

-Ensures data accuracy and integrity of managed information in order to avoid rework

CANDIDATE REQUIREMENTS:

-Demonstrated knowledge of GxP Quality systems, processes and procedures

-Excellent problem-solving skills; ability to resolve issues effectively and efficiently

-Ability to meet deadlines

-Demonstrated ability to handle complexity with strong organizational skills and attention to detail

-Ability to communicate effectively both orally and in writing

-Strong interpersonal skills; able to influence without direct authority

-Excellent data entry and computer application skills Knowledge of Microsoft Word, Excel, PowerPoint, Access and Outlook.

-Adept at queries, report writing, and presenting findings

HIGHLY DESIREABLE EXPERIENCE

-Annual Product Review documentation and compilation in a GxP environment (such as 503B compounding, pharmaceutical manufacturing, or medical device manufacturing)

-ASQ CQA certification, PMP certification, or similar certifications demonstrating critical thinking, planning, and scheduling competencies

-Deep familiarity with Quality System Requirements (especially CAPA systems, auditing, and/or Quality Control documentation practices)

WORK ENVIRONMENT

-This position is an office position and will not require travel.

-Extensive computer work and telephoning is anticipated.

  • -Extensive paperwork review is anticipated.

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