Bora Pharmaceuticals
Analyst I, QC Microbiology - 3rd Shift - Baltimore
Bora Pharmaceuticals, Baltimore, Maryland, United States, 21276
Overview
Analyst I, QC Microbiology - 3rd Shift - Baltimore. Responsible for conducting qualitative and quantitative microbial analyses in support of environmental monitoring, cGMP manufacturing and stability of drug products and incoming raw materials. This position supports the 3rd shift, working 10pm-6:30am, Monday through Friday. Responsibilities
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. Perform environmental monitoring during fill operations. Operate a biohazard trash autoclave. Perform daily checks on equipment. Stock the lab on a daily basis. Clean the lab and equipment. Prepare 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 SOPs and Testing Standards as necessary. Review, analyze, interpret and report data. Verify and enter 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. Participate in and attend professional seminars, conferences and conventions. Participation in biomedical screening is required. Minimum Education, Experience, Skills
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— maintaining a satisfactory level of technical and professional skill in position-related areas; staying updated on current developments and trends. Communication— clear and persuasive speech in various situations; conduct productive meetings. Planning/Organizing— prioritize and plan work activities; manage time efficiently. Safety and Security— observe safety procedures; may be required to lift items up to ~25 lbs. Adaptability — maintain effectiveness when changing tasks or environment. Stress Tolerance— perform under pressure and manage stress appropriately. Compensation
$47,077.00 - $70,615.00 Work Environment & Equal Opportunity
Bora Pharmaceuticals Injectables, Inc. is an equal employment opportunity employer. We recruit, hire, train and promote without regard to race, color, creed, religion, sex, national origin, age, marital status, familial status, disability, sexual orientation, gender identity, or any other protected category in accordance with applicable laws.
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Analyst I, QC Microbiology - 3rd Shift - Baltimore. Responsible for conducting qualitative and quantitative microbial analyses in support of environmental monitoring, cGMP manufacturing and stability of drug products and incoming raw materials. This position supports the 3rd shift, working 10pm-6:30am, Monday through Friday. Responsibilities
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. Perform environmental monitoring during fill operations. Operate a biohazard trash autoclave. Perform daily checks on equipment. Stock the lab on a daily basis. Clean the lab and equipment. Prepare 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 SOPs and Testing Standards as necessary. Review, analyze, interpret and report data. Verify and enter 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. Participate in and attend professional seminars, conferences and conventions. Participation in biomedical screening is required. Minimum Education, Experience, Skills
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— maintaining a satisfactory level of technical and professional skill in position-related areas; staying updated on current developments and trends. Communication— clear and persuasive speech in various situations; conduct productive meetings. Planning/Organizing— prioritize and plan work activities; manage time efficiently. Safety and Security— observe safety procedures; may be required to lift items up to ~25 lbs. Adaptability — maintain effectiveness when changing tasks or environment. Stress Tolerance— perform under pressure and manage stress appropriately. Compensation
$47,077.00 - $70,615.00 Work Environment & Equal Opportunity
Bora Pharmaceuticals Injectables, Inc. is an equal employment opportunity employer. We recruit, hire, train and promote without regard to race, color, creed, religion, sex, national origin, age, marital status, familial status, disability, sexual orientation, gender identity, or any other protected category in accordance with applicable laws.
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