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Company Contact Info

  • 1602 Main Street
    East Hartford, CT 06108
  • Taniesha Mendez
  • Phone: 860-569-5970
  • Phone:: 860-569-5975

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Quality Manager

Hamilton Connections • East Hartford, CT

Posted 5 days ago

Job Snapshot

Full-Time
Experience - Up to 3 year(s)
Degree - 4 Year Degree
$0.00 - $75,000.00 /Year
Chemical
QA - Quality Control

Job Description

  • Plans, coordinates, implements and directs a quality control program designed to ensure continuous production consistent with 21 CFR 111. 
  • Supervise, train and evaluate the Quality Control staff
  • Develops and analyzes data and product specifications to determine present standards and establish proposed quality and reliability of the finished product. 
  • Releases finished product to distribution.
  • Review batch records daily.
  • Coordination of all quality control records and fillings. 
  • Help develop training for all employees in cGMP principles and corporate compliance requirements
  • Insure quality standards set forth in SOP and cGMP.
  • Write SOPs and work instructions
  • Work with managers and teams to assess and ensure compliance with cGMP and company compliance plan against internal (policy/procedure) and external (contract/program) requirements; report regularly on results
  • Respond to, research and provide corrective actions to customer complaints regarding quality.
  • Interact with, and provide quality control guidance to, the production workforce.
  • Actively participate in FDA, GMP and other inspections and audits including required responses, follow up and corrective action documentation and implementation.
  • Conducts routine safety audits and training.
  • Other tasks as might be assigned
  • Strive for continuous improvement and participate in developing solutions to drive overall operational effectiveness including increase throughput, reduce movement/motion, waiting & transportation
  • Is responsible to scheduling intercompany trucking as needed.
  • Any other duties as they are needed and assigned.

Job Requirements

  • Bachelor’s Degree in appropriate discipline.
  • 3 + years’ experience with a Quality Team in the Dietary Supplement, Pharmaceutical, or closely related industry.
  • Significant experience and knowledge of cGMP and FDA regulations under 21 CFR 111.
  • Ability to analyze records with a high level of accuracy.
  • Highly developed organizational, interpersonal and management skills
  • Working knowledge of current FDA Quality Systems Regulations
  • Ability to work independently and resolve issues.
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