Quality Analyst III, QC Microbiology

  • location: North Billerica, MA
  • type: Permanent
  • salary: $65,000 - $80,000 per year
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job description

Quality Analyst III, QC Microbiology

job summary:
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location: North Billerica, Massachusetts
job type: Permanent
salary: $65,000 - 80,000 per year
work hours: 9 to 5
education: Bachelors
 
responsibilities:
Perform routine and advanced testing on incoming materials, finished products and stability studies in QC Laboratory. Perform routine environmental monitoring and utilities testing.

  • Familiar with aseptic technique
  • Perform Environmental Monitoring and utilities monitoring.
  • Perform bioburden, sterility, endotoxin and other routine and advanced testing.
RESPONSIBILITIES

  • Perform routine QC testing in accordance with SOPs and cGMP guidelines. Limited supervision required.
  • Perform verification of data to ensure accuracy. Perform approval upon discretion of supervisor.
  • Assist with audit readiness of laboratory area and calibration and maintenance of laboratory equipment.
  • Utilize a range of electronic systems such as LIMS and document/equipment management software.
  • Author and review SOP changes; participate in change controls, CAPAs and other quality systems.
  • Resolve routine and more advanced problems by utilizing appropriate resources. Provide problem solving skills to support investigations.
  • Participate in protocols for procedural and instrumentation validations.
  • Work on special projects as needed. Contribute towards continuous improvement.
  • Train on and maintain considerable knowledge of current regulatory requirements and relevant internal procedures.
  • Work independently and as a team player with quality and attention to detail. Good communication skills both oral and written. Effectively and efficiently participate in assigned tasks in a quality manner.
  • Actively promote safety rules and awareness. Report and take initiative to correct safety & environmental hazards. Work with potentially hazardous chemical, radiological and/or biological materials on a daily basis. Demonstrate good safety practices at all times including the appropriate use of protective equipment.
  • Promote and actively demonstrate the values of Accountability, Quality, Efficiency, Customer Service, Collaboration, and Safety, as well as appropriate workplace behaviors and professionalism, including respect, flexibility, and a positive attitude toward work and others.
 
qualifications:
  • Typically requires 3-5 years with a BS degree in a related scientific discipline (e.g. microbiology) or equivalent combination of education and previous relevant experience in the pharmaceutical industry, related GMP environment, or equivalent.
  • Routinely scheduled work, and/or overtime work required on evenings, weekends, and/or holidays, including during adverse weather conditions. Some non-routine travel may be required.
  • Work with (or in proximity to) potentially hazardous chemical, radiological, and or biological materials and must be able to lift/move materials, e.g. 30 lb. portable equipment, 50 lb. lead/shields.
 
skills: Quality Assurance, GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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