Quality Management Specialist

2 weeks ago


Hartford, Connecticut, United States KVK Tech Full time
Job Overview

Department

Quality Assurance

Position Title

Quality Management Specialist

1. Objective of the Role:

  • Guarantee the quality and adherence of the facility to regulatory standards.
  • Examine documentation, execute audits and inspections, and manage quality databases.
  • Deliver quality and compliance training, offering support during regulatory assessments.
  • Contribute to the formulation of Standard Operating Procedures (SOPs) and oversee quality document management activities.

2. Primary Responsibilities:

  • Conduct inspections of production areas to ensure compliance with SOPs and proper documentation practices.
  • Carry out internal audits of production areas to verify adherence to regulations.
  • Assess SOPs, specifications, and batch record documentation.
  • Monitor Key Performance Indicators (KPIs) related to production accuracy.
  • Review and maintain Quality Management Records.
  • Ensure compliance with aseptic production processes.
  • Draft and evaluate Standard Operating Procedures.
  • Execute quality audits and inspections.
  • Support quality enhancement initiatives.

4. Qualifications & Experience:

Associates Degree/Certification/Diploma in a laboratory science, or a B.S. / BSc / B.A. degree preferred.

1-3 years of relevant experience.

5. Required Skills/Certifications:

  • Proficient in reading, identifying, and accurately communicating details.
  • Self-driven with outstanding organizational abilities.
  • Familiarity with Microsoft Office applications.
  • High level of discretion when handling confidential information.
  • Effective communication skills and ability to follow detailed instructions.
  • Capability to provide training on SOPs and regulatory standards.

6. Physical Requirements and Work Environment:

Physical requirements include walking, sitting, using hands, and lifting items up to 20 pounds.



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