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Microbiology Quality Assurance Specialist

2 months ago

Canton, Massachusetts, United States Beacon Hill Full time

Beacon Hill Life Sciences is seeking a Quality Control Microbiologist (Level I or Level II) for a contract position.

Key Details:

  • Assignment Duration: 6 months
  • Location: Onsite
  • Compensation: Competitive pay rate based on experience, ranging from $45 to $70 per hour.

Qualifications:

To be eligible for this role, candidates must possess:

  • Recent experience in endotoxin testing, water sampling, and plate reading.
  • ISO 5A gowning experience.
  • A minimum of 3 years of microbiology experience in a GMP/GLP regulated setting.

Primary Responsibilities:

  • Conduct testing on raw materials, intermediates, and non-routine samples.
  • Perform endotoxin, microbiological, and water quality assessments.
  • Execute and interpret environmental, personnel, and in-process sterility tests.
  • Prepare and dispatch samples for microbiological identification and mycoplasma analysis.
  • Conduct visual inspections of final products.
  • Generate detailed trend reports related to quality assessments.
  • Revise and update Standard Operating Procedures (SOPs).
  • Engage in interdepartmental collaboration to address customer service needs.
  • Participate in high-level quality systems initiatives, including CAPA.
  • Contribute effectively in cross-functional team settings.
  • Communicate and collaborate appropriately in various scenarios.
  • Independently manage project execution while knowing when to involve others.
  • Identify opportunities to minimize errors and reduce costs.
  • Take ownership of all deliverables.

Essential Requirements:

  • Bachelor's degree in Microbiology or a related field is preferred; at least an Associate's degree is required.
  • 3-4 years of microbiology experience in a GMP/GLP environment.
  • Experience with endotoxin testing, water sampling, and plate reading is essential.
  • Preferred experience includes Environmental Monitoring (EM), Bioburden, Sterility, and Bacteriostasis/Fungistasis testing.
  • ISO 5A gowning experience is a must.
  • Familiarity with cGMP and GLP regulations and compendial requirements.
  • Understanding of laboratory safety protocols.
  • Proficiency in computer applications for data management and communication (Microsoft Excel, Word, Outlook, and Access).
  • Strong written and verbal communication skills.

Work Environment:

  • This role primarily takes place in a laboratory setting, with some time spent in an office environment. The laboratory is a fast-paced BL2 category lab requiring the use of personal protective equipment (PPE) such as gloves and lab coats.
  • Handling of biohazardous materials and chemicals is required.
  • The position involves standing for 3-5 hours daily, with frequent bending and lifting, as well as repetitive hand movements for tasks such as micropipetting and keyboard use.
  • Occasional lifting or moving of items up to 15 pounds may be necessary.

Beacon Hill is an Equal Opportunity Employer that values diversity in the workplace. We encourage individuals with disabilities and protected veterans to apply.