Quality Control Specialist Environmental Monitoring

4 days ago


Worcester, Massachusetts, United States SPECTRAFORCE Full time
Job Title: Quality Control Technician Environmental Monitoring

Duration: 12 Months

Location: Worcester MA

Key Responsibilities:
  • Perform routine Environmental Monitoring testing within a GMP environment.
  • Conduct Environmental Monitoring (EM) during a fill operation.
  • Support other lab-associated functions.
  • Execute 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 to complete assigned tasks as committed.
  • Support investigation writers and approvers gather data.
  • Write or revise procedures with guidance.
  • Work under the guidance of a supervisor but is able to manage their own time to ensure timely completion of assigned duties.
  • Trend data to support trend reports.
  • Must be willing to work on weekends and holidays.
Requirements:
  • 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.
  • Should have 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.
  • Must be flexible working weekends and holidays.
  • 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.
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.
  • Top 3-5 skills requirements should this person have?
  • QC Micro experience - Hands-on experience with lab testing and EM.
  • Attention to detail while running assays/tasks in the lab and while performing EM is required.
  • Should have 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.
  • Must be flexible working weekends and holidays.
  • 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.
  • Must be comfortable standing for most of their shift.
  • Shuttling between buildings is required. Also, must be flexible to work (some) weekends and holidays (pre-scheduled).
  • What is a nice to have (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 standing for long periods of time.
  • Experience Level = 3-5 Years.


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