Favorites ()

Recent Searches

loading

Quality Investigator

Wilson, NC

Order: 1221949
Payrolled

Position Overview

The Quality Investigator is an individual supporting activities throughout the pharmaceutical manufacturing plant.  Primary responsibilities include conducting and writing operation investigations, delivering CAPA plans and compliance reports.  Have a willingness to take the initiative to resolve problems, discuss and make necessary recommendations. The assessment of GMP investigation, CAPA and compliant in compliance in accordance to cGMP, GLP, GXP, FDA, ICH, EU and 21 CFR 11 regulations, guidelines, body policies and procedures departments towards applicable Standard Operating Procedures (SOPs).  The tasks involves working with a broad scope of review and analysis of the site's quality system with the intent to identify root cause analysis for operations and complaints.

 

The Quality Investigator is responsible for completing investigations, providing documented evidence of root cause and Corrective and Preventative Actions for plant quality issues. This individual will work closely with employees at multiple levels within the organization in order to achieve timely completion of investigations.

JOB RESPONSIBILITY

  • Conduct and write formal investigation reports with the assistance of plant personnel and oversight from manager.

  • Perform impact risk assessment as well as assist in root cause determination and plans appropriate corrective action and preventative action.

  • Perform reviews and evaluate sensitive, confidential information and develops recommendations for use by the plant quality assurance department.

  • Spearhead implementation of improvements to analytical test methods through change control process

QUALIFICATION:

  • Minimum of 5 years’ experience in a science related position, pharmaceutical industry preferred.

  • 4 years’ experience in a manufacturing site.

  • 4 or more years in a pharmaceutical facility.

  • Minimum 2 years leadership experience preferred

  • BS degree in science field is preferred

  • Excellent verbal and written communication skills and attention to detail.

 

 

ESSENTIAL FUNCTIONS:

  • Conduct and generate investigation report,  root cause analysis, and correlating CAPAs associated with operation activities

  • Conduct compliant investigation, generate correlating documents to reporting the findings through the investigation, make sound recommendation to potential resolution.

  • A strong knowledge of quality system regulations/requirements for drug (i.e., FDA-Food and Drug Administration, GMP-Good Manufacturing Practices, ISO-International Organization for Standardization, QSR-Quality System Regulation, ICH -International Committee on Harmonization).

  • Works closely with other functions within the organization (Manufacturing, R&D, QC, microbiology, IT, calibration, metrology, material and distribution and Engineering) and is responsible for ensuring the quality and compliance through the action of operations.

  • Effective communication skills at all levels both written and verbal.

  • Knowledge, use and application of change controls, investigation process, root cause analysis (i.e. 6M, fish bone etc.), CAPAs, and complaint

  • The ability to mentor and advice junior team members for various groups within Ability to perform multiple tasks and ability to effectively manage conflict.

  •  Ability to work in teams to obtain results, self-motivated/directed, ability to organize and adjust to a changing schedule of priorities.

  • Knowledge of manufacturing processes, utilities, and relevant statistical techniques (Six Sigma, Statistical Process Control (SPC), lean or equivalent).

  • Represent quality as an adviser when on assigned to a project.

  • Readily identify and analyze problems and generate effective courses of action.

  • Basic to intermediate proficiency in Microsoft Office and statistical programs (i.e. MiniTab, and SAP).

  • Understanding of continuous improvement methodologies including lean, six sigma, and validation.

  • Maintain currency of company SOPs, and policies

        • Assist in the department completion of trending and metrics (i.e Cost of Poor Quality, Key Performance Indicators, Quality Management Reviews, & Data Trend Analysis).

 

 

Job Requirements

  1. MINIMUM REQUIREMENTS:

Education required/ preferred:

BS/BA degree in engineering, Life Sciences or Business preferred

Experience:

Minimum 4-5 years of experience in a pharmaceutical manufacturing setting