Environmental Monitoring Analyst - Abzena

Environmental Monitoring Analyst

Location: San Diego, CA
Area: Quality

Current Responsibilities

  • Perform routine, non-routine environmental monitoring (EM) of the GMP manufacturing facilities for total particulates, air viables, and surface viables.
  • Initiate and participate in the investigations of EM excursions and assess any potential impact on product quality.
  • Assist in trending EM data and generate quarterly reports and yearly reports.
  • Perform routine monitoring of pharmaceutical water systems.
  • Perform routine monitoring of pharmaceutical gas systems.
  • Perform bioburden and endotoxin testing.
  • Perform analysis and data analysis of in-process samples, APIs, and stability samples using existing methods.
  • Support assay transfer, qualification and validation activities for client’s specific methods.
  • Author and review Quality Control standard operating procedures (SOPs) and assay qualifications.
  • Maintain QC lab equipment and provide assistance, as needed, during equipment and facility qualification activities.
  • Interact closely with other departments to ensure efficient, compliant and timely execution of project activities.
  • Provide assistance as needed to maintain functioning QC Laboratory, including material ordering, inventory control, general housekeeping and other duties.
  • Assist in investigation and review of GMP quality events, including but not limited to deviations, out of specification reports, and audit findings.
  • Operate at a consistent and exemplary level of efficiency, producing high quality and accurate results with a customer driven focus.
  • Safely operate laboratory equipment in accordance with established practices.

 

General Responsibilities:

  • Operates to the highest ethical and moral standards.
  • Complies with Abzena’s policies and procedures.
  • Adheres to quality standards set by regulations and Abzena’s policies, procedures and mission.
  • Communicates effectively with supervisors, colleagues and subordinates.
  • Ability to participate effectively as a team player in all aspects of Abzena business.
  • Travels as needed.

 

Qualifications/Skills Required:

  • BS degree in a relevant discipline (e.g., microbiology, chemistry, biological sciences, bioengineering, etc.).
  • Minimum two (2) years of experience in environmental monitoring of GMP facilities.
  • Minimum two (2) years of experience working in a GMP microbiology lab.
  • Preferred knowledge in environmental excursion investigations, root cause analysis, and/or knowledge of cleanroom practices.
  • Experience with one or more of the methods such as: bioburden, endotoxin, total organic carbon, conductivity, or Gram staining.
  • Knowledge of and experience in GMP, following standard test methods, or willingness to become GMP proficient.
  • Ability to gown for and work in a cleanroom environment.
  • Skill to accurately and precisely document and record laboratory activities, results, and conclusions.
  • Ability to use routine laboratory equipment including, but not limited to, particle counters, air samplers, microscopes, etc.
  • Ability to work well under pressure, multi-task, and have good organizational and communication skills.
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