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Bora Pharmaceuticals · 1 month ago

Analyst I, QC Microbiology-2nd Shift

Baltimore, MD

Full-time

Onsite

New Grad, Entry Level

$47K/yr - $71K/yr

0+ years exp

Bora Pharmaceuticals is seeking an Analyst I for their QC Microbiology team. This role involves conducting microbial analyses, supporting environmental monitoring, and ensuring the quality of drug products and raw materials.

Pharmaceutical

Responsibilities

Perform various microbiological testing procedures as per manufacturing/Quality Control batch records, stability protocols, raw material requests for testing, etc

Achieve gowning and aseptic qualification within 4 months

Maintains aseptic qualification and ability to support aseptic filling operations, up to 50% of time directly supports aseptic operations

Maintains gowning qualification

Perform environmental monitoring and utility testing of the facility

Performs environmental monitoring during fill operations

Operation of a biohazard trash autoclave

Perform daily checks on equipment

Stock the lab on a daily basis

Cleaning the lab and equipment

Prepping of materials requiring sterilization

Inform supervisor/manager upon observing OOS, OOL, or generation of deviations

Participate in validation, troubleshooting various types of equipment including proactive resolution of instrument issues

Write and review SOP’s and Testing Standards as necessary

Review, analyze, interpret and report data

Verifies and enters approved results in laboratory information management systems (LIMS)

Prepare disinfectant solutions, reagents, samples for analyses

Participate in investigations and other related studies

Practice Good Documentation and Laboratory Safety Procedures per the Standard Operating Procedures

Track time worked per project

Observe and report issues during filling operations

Qualification

MicrobiologyAseptic processingEnvironmental monitoringQuality ControlLaboratory Information Management Systems (LIMS)Technical KnowledgePlanning/OrganizingSafetySecurityStress ToleranceCommunicationAdaptability

Required

BS in Microbiology/Biology or related field

Minimum of 0 - 2 years in the Pharmaceutical or Biotechnology with emphasis in one of the following areas: aseptic processing, QC, Microbiology, environmental monitoring, water system, quality control, validation and manufacturing processes

Technical/Professional Knowledge— having achieved a satisfactory level of technical and professional skill or knowledge in position-related areas; keeping up with current developments and trends in areas of expertise

Communication— the individual speaks clearly and persuasively in positive or negative situations, demonstrates group presentation skills and conducts productive meetings

Planning/Organizing— the individual prioritizes and plans work activities, uses time efficiently and develops realistic action plans

Safety and Security— the individual observes safety and security procedures and uses equipment and materials properly. May be required to lift items that are approximately 25lbs

Adaptability – maintains effectiveness when experiencing major changes in work tasks or the work environment; adjusting effectively to work within new work structures, processes, requirements, or cultures

Stress Tolerance— maintaining stable performance under pressure or opposition (such as time pressure or job ambiguity); handling stress in a manner that is acceptable to others and to the organization