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Quality Assurance Specialist

1 month ago

Worcester, Massachusetts, United States Synectics Inc Full time
{"Job Title": "Quality Control Technician", "Job Description": "Job Overview

At Synectics Inc, we are seeking a highly skilled Quality Control Technician to join our team. As a key member of our laboratory team, you will be responsible for performing routine Environmental Monitoring testing within a GMP environment. You will also be responsible for supporting other lab-associated functions, including performing test methods as written to support product/material release.

Key Responsibilities
  • Perform routine Environmental Monitoring testing within a GMP environment.
  • Support other lab-associated functions, including performing test methods as written to support product/material release.
  • Effectively perform a multitude of laboratory techniques with minimal error for which you will be trained on.
  • Understand, implement, and maintain GMP with respect to laboratory records, procedures, and systems in accordance with procedural requirements.
  • Accept responsibility to complete assigned tasks as committed.
  • Support investigation writers and approvers to gather data.
  • Effectively perform a multitude of laboratory techniques with minimal error for which you are or will be trained on.
  • Writes or revises procedures with guidance.
  • Works under the guidance of a supervisor but is able to manage their own time to ensure timely completion of assigned duties.
  • Trends data to support trend reports.
Requirements
  • BS in Biology or other life science required.
  • QC Micro experience - Hands-on experience with lab testing and EM.
  • Hands-on Aseptic Technique experience preferable.
  • Hands-on working experience in Biosafety hoods preferable.
  • Attention to detail while running assays/tasks in the lab and while performing EM is required.
  • Good organizational skills, ability to prioritize workload and extremely thorough with excellent attention to detail.
  • Should perform tasks with supervision guidance, taking responsibility for complying with GMP requirements.
  • Strong interpersonal/communication skills.
  • Maintaining good working relationships within and outside the department.
  • Adjusting quickly to new situations. Reprioritizing to meet schedule demands in continually changing work environment.
  • Knowledge with the LIMS system, specifically entering results is preferred.
  • Knowledge of applicable regulations and standards affecting Pharmaceutical Products (e.g. USP, EP, JP pharmacopoeias, ICH guidelines, cGMP) is preferred.
  • GMP and/or Clean-Room experience.
  • Clean-Room Gowning.
  • Experience with cGMP documentation and record maintenance is required.
  • This job requires standing for long periods of time.
  • Experience Level = 3-5 Years.
", "lang_code": "en"}