Analyst I, QC Microbiology (3rd 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 supports the Microbiology, Environmental Monitoring, and Utility testing programs and works the 3rd shift (10 pm‑6:30 am, Monday‑Friday). Shift differential. Essential Functions 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. Minimum Education, Experience, Skills To perform the job successfully, an individual should demonstrate the following competencies. 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. Knowledge College and industry-level knowledge of general microbiology principles. Demonstrate the ability to investigate and identify causes of suspect laboratory results. Must be comfortable working in cleanrooms and BSC environments in aseptic gowning for extended periods of time. Skills 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. Problem Solving – the individual identifies and resolves problems in a timely manner and gathers and analyzes information skillfully. 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 25 lbs. Communication – effective verbal and written communication, the ability to complete daily tasks as assigned, the ability to work independently and in a group, and the ability to multitask. Speaks clearly and persuasively in positive or negative situations, demonstrates group presentation skills and conducts productive meetings. Quality Management – looks for ways to improve and promote quality and demonstrates accuracy and thoroughness. Planning/Organizing – prioritizes and plans work activities, uses time efficiently and develops realistic action plans. 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 – maintains 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. Ability to succeed in a team‑oriented environment under very dynamic conditions. Must be able to write legibly and accurately and contemporaneously record work in written and electronic form. Proven demonstration of qualifications related to Excel, Word, LIMS, or SAP systems is preferred, including coursework. Salary Range 60,000 - 75,000 Compensation and Benefits Competitive salary and performance-based incentives Comprehensive health coverage including medical, dental, and vision insurance Retirement savings plans with employer matching contributions Paid time off Professional development opportunities Employee wellness programs and resources Employee Assistance Program and Mental Health Resources Equal Employment Opportunity Bora Pharmaceuticals 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 will recruit, hire, train and promote persons in all job titles, without regard to race, color, creed, religion, sex (including factors related to pregnancy or child birth), national origin, age, marital status, familial status, disability, sexual orientation, gender identity status with regard to public assistance, employment status, local human rights commission activity, status as a protected veteran, genetic information, atypical hereditary cellular or blood trait, or any other protected category. #J-18808-Ljbffr Bora Pharmaceuticals