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Sr. Quality Specialist

Townsend & Associates • Rocky Mount, NC

Posted 25 days ago

Job Snapshot

Contractor
Travel - None
Experience - 5 to 7 years
Degree - 4 Year Degree
Competitive salary based on experience
Biotechnology, Pharmaceutical, Other Great Industries
QA - Quality Control, Pharmaceutical, Other
120

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Job Description

Sr. Quality Specialist

Responsibilities:
  • Conduct and write complex formal investigation reports with input from area SMEs.
  • Function as an independent reviewer of drafted investigations providing constructive feedback and in some instances act as a coach to the investigator.
  • Perform impact risk assessment as well as assist in root cause determination and plans appropriate corrective action and preventative action.
  • Assist in the tracking and trending of corrective and preventative action to assure timely closure.
  • Perform reviews and evaluate sensitive, confidential information and develops recommendations for use by the plant quality assurance department.
  • Ability to interface with multiple levels of people in the organization, including plant personnel and senior management.
  • Organize data, extract key information and write technical summary reports.
 
Sr. Quality Specialist

Job Requirements

Sr. Quality Specialist

W2 ONLY!!! NO CORP TO CORP

Qualifications:
  • Bachelor’s degree (science preferred) with 3-5 years’ experience in the FDA regulated industry.
  • 3-5 years’ experience in pharmaceutical quality environment required.
  • Experience in sterile manufacturing and an understanding of the sterilization process and its impact to products.
  • Working knowledge of environmental monitoring and aseptic manufacturing.
  • Understanding of process validation requirements.
  • American Society for Quality (ASQ) certification is an asset.
  • Pharmaceutical operations experience and/or knowledge.
  • Experience in a solutions facility preferred.
  • Working knowledge of FDA regulations.
  • Knowledge of various quality tools such as root cause analysis, DMAIC process, fishbone analysis, etc.
  • Prior investigation writing experience (with determination of product impact).
  • Excellent facilitation skills and ability to facilitate strategy meetings.
  • Superior technical writing and problem solving skills.
  • Expertise with word-processing, spreadsheet, and presentation software.
  • TrackWise experience a plus.

Sr. Quality Specialist
Job ID: 17-00699
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