Specific Job Duties: Perform Sterility testing as a main priority with efficiency and accuracy With a high degree of technical flexibility, work across diverse areas within the lab Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of assays. Report, evaluate, back-up/archive, trend and approve analytical data. Troubleshoot, solve problems and communicate with stakeholders. Initiate and/or implement changes in controlled documents. Participate in audits, initiatives, and projects that may be departmental or organizational in scope. Write protocols and perform assay validation and equipment qualification/verification. Introduce new techniques to the lab, including method transfers, reports, validations and protocols. Evaluate lab practices for compliance and operational excellence improvement on a continuous basis. Approve lab results May participate in lab investigations. May provide technical guidance. May train others. May contribute to regulatory filings. May represent the department/organization on various teams May interact with outside resources Basic Qualifications Bachelors degree in a science discipline Biopharmaceutical QC experience in a microbiology lab Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products Preferred Qualifications Experience in a wide variety of microbiological techniques, including but not limited to Bioburden, Endotoxin, Sterility (in an Isolator), Environmental Monitoring, Rapid Micro techniques, Microbial Identification, Media prep, Water Sampling. Understanding and application of principles, concepts, theories and standards of GMP QC microbiology laboratories. Deepens technical knowledge through exposure and continuous learning Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery Skills Take initiative to identify and drive improvements Excellent verbal and written communication skills Strong Technical writing skills for GMP documentation (e.g. investigations, procedures, change controls) Presentation skills Escalate issues professionally and on a timely basis Decision Making skills Teamwork and Coaching others Negotiation and Influence skills Problem solving skills Applies research, information gathering, analytical, and interpretation skills to problems of diverse scope Ensures compliance within regulatory environment Develops solutions to technical problems of moderate complexity Screens, categorizes, evaluates, reconciles, reports, and resolves data integrity issues Interprets generally defined practices and methods Able to use statistical analysis tools to perform data trending and evaluation Project Management and organizational skills, including ability to follow assignments through to completion Competencies Technically strong background in microbiology and aseptic manufacturing Experience in LIMS, Chah ange Control, Trackwise, SAP and EDMQ an advantage Experience with Regulatory inspectors and interacting with inspectors desirable Demonstrated ability to work independently and deliver right first time results Works under minimal direction Work is guided by objectives of the department or assignment Follows procedures Refers to technical standards, principles, theories and precedents as needed May set project timeframes and priorities based on project objectives and ongoing assignments. Recognizes and escalates problems Demonstrated leadership and communication skills Auditing documentation and operation process Demonstrated ability to interact with regulatory agencies Specific Job Duties: Perform analytical testing as a main priority with efficiency and accuracy With a high degree of technical flexibility, work across diverse areas within the lab Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of assays. Report, evaluate, back-up/archive, trend and approve analytical data. Troubleshoot, solve problems and communicate with stakeholders. Initiate and/or implement changes in controlled documents. Participate in audits, initiatives, and projects that may be departmental or organizational in scope. Write protocols and perform assay validation and equipment qualification/verification. Introduce new techniques to the lab, including method transfers, reports, validations and protocols. Evaluate lab practices for compliance and operational excellence improvement on a continuous basis. Approve lab results May participate in lab investigations. May provide technical guidance. May train others. May contribute to regulatory filings. May represent the department/organization on various teams May interact with outside resources Basic Qualifications Bachelors degree in a science discipline Biopharmaceutical QC experience in a microbiology lab Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products Preferred Qualifications Experience in a wide variety of microbiological techniques, including but not limited to Bioburden, Endotoxin, Sterility (in an Isolator), Environmental Monitoring, Rapid Micro techniques, Microbial Identification, Media prep, Water Sampling. Understanding and application of principles, concepts, theories and standards of GMP QC microbiology laboratories. Deepens technical knowledge through exposure and continuous learning Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery Skills Take initiative to identify and drive improvements Excellent verbal and written communication skills Strong Technical writing skills for GMP documentation (e.g. investigations, procedures, change controls) Presentation skills Escalate issues professionally and on a timely basis Decision Making skills Teamwork and Coaching others Negotiation and Influence skills Problem solving skills Applies research, information gathering, analytical, and interpretation skills to problems of diverse scope Ensures compliance within regulatory environment Develops solutions to technical problems of moderate complexity Screens, categorizes, evaluates, reconciles, reports, and resolves data integrity issues Interprets generally defined practices and methods Able to use statistical analysis tools to perform data trending and evaluation Project Management and organizational skills, including ability to follow assignments through to completion Competencies Technically strong background in microbiology and aseptic manufacturing Experience in LIMS, Chah ange Control, Trackwise, SAP and EDMQ an advantage Experience with Regulatory inspectors and interacting with inspectors desirable Demonstrated ability to work independently and deliver right first time results Works under minimal direction Work is guided by objectives of the department or assignment Follows procedures Refers to technical standards, principles, theories and precedents as needed May set project timeframes and priorities based on project objectives and ongoing assignments. Recognizes and escalates problems Demonstrated leadership and communication skills Auditing documentation and operation process Demonstrated ability to interact with regulatory agencies To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process, click the Apply button below to Login/Register.