Analyst , QC Microbiology-2nd Shift

JOB SUMMARY

The Analyst I, QC Microbiology is responsible for conducting qualitative and quantitative microbial analyses in support of environmental monitoring, cGMP manufacturing and stability of drug products and incoming raw materials. The Microbiologist is responsible for performing activities in support of the Microbiology, Environmental Monitoring, and Utility testing programs. This position will support our 2nd shift, working 2pm-10:30pm Monday-Friday.

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

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

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions.

To perform the job successfully, an individual should demonstrate the following competencies to perform the essential functions of this position.

Education:

BS in Microbiology/Biology or related field.

Experience:

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.

The physical/mental demands are representative of those that must be met by an individual to successfully perform the essential functions of the job.

The work environment characteristics described here are representative of those an individual would encounter while performing the essential functions of the job.

Compensation Range: $47,077.

Bora Pharmaceuticals Injectables, Inc. is committed to providing equal employment opportunity to all applicants and employees according to all applicable equal opportunity and affirmative action laws, directives and regulations of federal, state and local governing bodies and agencies. In keeping with this commitment, Bora Pharmaceuticals Inject, Inc. will recruit, hire, train and promote persons in all job titles, without regard to race, color, creed, religion, sex (including factors related to…