Bora Pharmaceuticals
Analyst II, QC Microbiology-2nd Shift
Bora Pharmaceuticals, Baltimore, Maryland, United States, 21276
Overview
Analyst II, QC Microbiology-2nd Shift at Bora Pharmaceuticals. The Analyst II, QC Microbiology position supports the Quality Control group at Bora Pharmaceuticals Camden Campus to maintain process optimization and manufacturing activities. The Microbiologist performs activities in support of the Microbiology, Environmental Monitoring, and Utility testing programs, including microbiological product testing, monitoring of the manufacturing production space, and supporting quality initiatives. The individual routinely conducts monitoring, testing, and SOP generation and revision. This position will support the 2nd shift, working 2:00 PM–10:30 PM, Monday–Friday. Essential Functions
Achieve gowning and aseptic qualification within 4 months. Maintain aseptic qualification and support aseptic filling operations, up to 50% of time directly supporting aseptic operations. Maintain 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 proficiently. Perform environmental monitoring during fill operations proficiently. Work with Project Managers and QA to ensure timely testing and release of samples. Inform supervisor/manager upon observing out-of-specifications (OOS), out-of-limit (OOL), or generation of deviations. Participate in investigations of OOS results and related studies. Participate in validation, troubleshooting various equipment and proactive resolution of instrument issues. Investigate and suggest new laboratory procedures/techniques; validate and implement them. Update existing or write new testing standards and standard operating procedures. Train Microbiologist I & II in methods and techniques. Review, analyze, interpret, and report data. Practice Good Documentation and Laboratory Safety Procedures per SOPs. Support department compliance and productivity goals. Write and review monthly reports as necessary. Track time worked per project. Own Change Controls and change actions; authors deviation investigations. Proficient with document management system and own updates to procedures. Perform aseptic technique/contamination control training. Observe and report issues during filling operations. Minimum Education, Experience, Skills
Education : BS in Microbiology/Biology or related field Experience : Minimum 2-4 years (MS with 0-2 years) in the Pharmaceutical or Biotechnology field 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 — maintains a satisfactory level of technical and professional skill, keeps up with current developments in area of expertise. Problem Solving — identifies and resolves problems in a timely manner and analyzes information. Safety and Security — follows safety procedures and uses equipment properly; may be required to lift items up to ~25 lbs. Communication — clear and persuasive in various situations; conducts productive meetings. Quality Management — seeks ways to improve quality and demonstrates accuracy and thoroughness. Planning/Organizing — prioritizes and plans work effectively; develops realistic action plans. Adaptability — maintains effectiveness under changes in tasks or environment. Stress Tolerance — maintains stable performance under pressure. Knowledge : College and industry-level knowledge in Quality Control Microbiology in cGMP environments. Knowledge of aseptic gowning and proficient aseptic techniques for microbial testing and environmental monitoring and utility testing of the facility. Skills : Proficient with Excel and Word; able to write legibly and record work accurately; strong technical writing and investigation reporting; able to write and review testing standards and SOPs. Abilities : Effective verbal and written communication; ability to complete daily tasks, improve processes, work independently or in a team, multi-task, and train others; familiarity with computer-based programs and systems; experience with Excel, Word, LIMS, or SAP preferred. Compensation
$56,919.00 - $85,379.00 Employment Details
Seniority level: Mid-Senior level Employment type: Full-time Job function: Quality Assurance Industries: Pharmaceutical Manufacturing EEO Statement:
Bora Pharmaceuticals Injectables, Inc. is committed to providing equal employment opportunity to all applicants and employees according to applicable laws and regulations. Bora Pharmaceuticals will recruit, hire, train and promote without regard to race, color, creed, religion, sex, national origin, age, disability, or any other protected category.
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Analyst II, QC Microbiology-2nd Shift at Bora Pharmaceuticals. The Analyst II, QC Microbiology position supports the Quality Control group at Bora Pharmaceuticals Camden Campus to maintain process optimization and manufacturing activities. The Microbiologist performs activities in support of the Microbiology, Environmental Monitoring, and Utility testing programs, including microbiological product testing, monitoring of the manufacturing production space, and supporting quality initiatives. The individual routinely conducts monitoring, testing, and SOP generation and revision. This position will support the 2nd shift, working 2:00 PM–10:30 PM, Monday–Friday. Essential Functions
Achieve gowning and aseptic qualification within 4 months. Maintain aseptic qualification and support aseptic filling operations, up to 50% of time directly supporting aseptic operations. Maintain 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 proficiently. Perform environmental monitoring during fill operations proficiently. Work with Project Managers and QA to ensure timely testing and release of samples. Inform supervisor/manager upon observing out-of-specifications (OOS), out-of-limit (OOL), or generation of deviations. Participate in investigations of OOS results and related studies. Participate in validation, troubleshooting various equipment and proactive resolution of instrument issues. Investigate and suggest new laboratory procedures/techniques; validate and implement them. Update existing or write new testing standards and standard operating procedures. Train Microbiologist I & II in methods and techniques. Review, analyze, interpret, and report data. Practice Good Documentation and Laboratory Safety Procedures per SOPs. Support department compliance and productivity goals. Write and review monthly reports as necessary. Track time worked per project. Own Change Controls and change actions; authors deviation investigations. Proficient with document management system and own updates to procedures. Perform aseptic technique/contamination control training. Observe and report issues during filling operations. Minimum Education, Experience, Skills
Education : BS in Microbiology/Biology or related field Experience : Minimum 2-4 years (MS with 0-2 years) in the Pharmaceutical or Biotechnology field 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 — maintains a satisfactory level of technical and professional skill, keeps up with current developments in area of expertise. Problem Solving — identifies and resolves problems in a timely manner and analyzes information. Safety and Security — follows safety procedures and uses equipment properly; may be required to lift items up to ~25 lbs. Communication — clear and persuasive in various situations; conducts productive meetings. Quality Management — seeks ways to improve quality and demonstrates accuracy and thoroughness. Planning/Organizing — prioritizes and plans work effectively; develops realistic action plans. Adaptability — maintains effectiveness under changes in tasks or environment. Stress Tolerance — maintains stable performance under pressure. Knowledge : College and industry-level knowledge in Quality Control Microbiology in cGMP environments. Knowledge of aseptic gowning and proficient aseptic techniques for microbial testing and environmental monitoring and utility testing of the facility. Skills : Proficient with Excel and Word; able to write legibly and record work accurately; strong technical writing and investigation reporting; able to write and review testing standards and SOPs. Abilities : Effective verbal and written communication; ability to complete daily tasks, improve processes, work independently or in a team, multi-task, and train others; familiarity with computer-based programs and systems; experience with Excel, Word, LIMS, or SAP preferred. Compensation
$56,919.00 - $85,379.00 Employment Details
Seniority level: Mid-Senior level Employment type: Full-time Job function: Quality Assurance Industries: Pharmaceutical Manufacturing EEO Statement:
Bora Pharmaceuticals Injectables, Inc. is committed to providing equal employment opportunity to all applicants and employees according to applicable laws and regulations. Bora Pharmaceuticals will recruit, hire, train and promote without regard to race, color, creed, religion, sex, national origin, age, disability, or any other protected category.
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