Demo

Field Specialist QA Operations

Cynet Systems
Devens, MA Contractor
POSTED ON 2/7/2025
AVAILABLE BEFORE 4/5/2025
Job Description:

Pay Range: $49hr - $53hr

Responsibilities:
  • Perform QA on the floor activities.
  • Ensure manufacturing compliance with applicable procedures and batch records.
  • Perform real time review of manufacturing batch records.
  • Review manufacturing shop floor documentation.
Education Requirements:
  • Relevant college or university degree required.
  • Minimum 4 years relevant work experience, with experience in a Quality Assurance role.
Qualifications Required:
  • Equivalent combination of education and experience acceptable.
  • Must be action-oriented and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking.
  • Understands continuous improvement and improves efficiency and productivity within the group or project.
  • Builds relationships internally within and with cross functional teams.
  • Must have sound knowledge and experience in FDA regulated cGMP warehousing, Quality, and compliance environments. Prefer to also have knowledge of GMP Manufacturing operations and processes.
  • Directs quality initiatives that accomplish continuous improvement and enhance site quality system efficiencies.
  • Routinely recognizes and resolves Quality issues; Informs management of proposed solutions. Seeks management guidance on complex issues.
  • Able to recognize conflict and notify management with proposed recommendations for resolution.
  • Must possess an independent mindset. Work is self-directed.
  • Requires moderate direction to complete more complex tasks; completes routine tasks with little or no supervision.
  • Confident in making decisions for non-routine issues.
  • Develops and revises procedures.
  • Intermediate to advanced ability to interpret results and situations and articulate recommendations for resolution.
  • Able to prepare written communications and communicate problems to management with clarity and accuracy.
  • Able to effectively multi-task.
  • Must have strong authorship and ability to critically review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles.
  • Must be skilled in planning and organizing, decision-making, and building relationships.
  • Knowledge of quality processes, including material disposition, change control, product complaints, deviations, investigations, and CAPA management.
  • Able to effectively multi-task.
  • Must have strong authorship and ability to critically review investigations, interpret results and generate technical conclusions consistent with Quality Risk Management principles.
  • Must be skilled in planning and organizing, decision-making, and building relationships.
  • Knowledge of quality processes, change control, product complaints, deviations, investigations, and CAPA management.

Salary : $49 - $53

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