Quality Control Technician

1 month ago

Worcester, United States SPECTRAFORCE Full time

Job Title: Quality Control Technician

Duration: 12 Months

Location: Worcester MA

  • Performs routine Environmental Monitoring testing within a GMP environment.
  • Performs Environmental Monitoring (EM) during a fill operation.
  • Supports other lab-associated functions.
  • Perform test methods as written to support product/material release.
  • Effectively perform a multitude of laboratory techniques with minimal error for which they will be trained on. Understand, implement, and maintain GMP with respect to laboratory records, procedures, and systems in accordance with procedural requirements.
  • Accept responsibility tcomplete assigned tasks as committed.
  • Support investigation writers and approvers gather data. effectively perform a multitude of laboratory techniques with minimal error for which they 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.
  • Should be willing twork on weekends and holidays.

Top Skills:

  • QC Micrexperience- -Hands- on experience with lab testing and EM.
  • hands- on Aseptic Technique experience preferable.
  • hands- on working experience in Biosafety hoods preferable.
  • Attention tdetail while running assays/ tasks in the lab and while performing EM is required
  • Should have good organizational skills, ability tprioritize workload and extremely thorough with excellent attention to detail.
  • Should perform tasks with supervision guidance, taking responsibility for complying with GMP requirements.
  • MUST be flexible working weekends and holidays.
  • Strong interpersonal / communication skills. Maintaining good working relationships within and outside the department.
  • Adjusting quickly tnew situations. Reprioritizing tmeet schedule demands in continually changing work environment.
  • Knowledge with the LIMS system, specifically entering results is preferred

Nice to have:

  • 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

Years of experience/education and/or certifications required:

  • BS in Biology or other life science required
  • What are the top 3-5 skills requirements should this person have?
  • QC Micrexperience- -Hands- on experience with lab testing and EM.
  • Attention tdetail while running assays/ tasks in the lab and while performing EM is required
  • Should have good organizational skills, ability tprioritize workload and extremely thorough with excellent attention to detail.
  • Should perform tasks with supervision guidance, taking responsibility for complying with GMP requirements.
  • MUST be flexible working weekends and holidays.
  • Strong interpersonal / communication skills. Maintaining good working relationships within and outside the department.
  • Adjusting quickly tnew situations. Reprioritizing tmeet schedule demands in continually changing work
  • environment.
  • **Must be comfortable standing for most of their shift.
  • Shuttling between buildings is required. Also, must be
  • flexible twork (some) weekends and holidays (pre-scheduled).
  • What is a nice thave (but not required) regarding skills, requirements, experience, education, or certification?
  • 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 to standing for long periods of time
  • Experience Level = 3-5 Years

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