Specific Job Duties :
Perform Environmental Monitoring in aseptic processing areas.
Perform analytical testing with efficiency and accuracy
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 performvalidation 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
Working as part of a 24 / 5 shift pattern.
Bachelor's degree in a science discipline
Experience in a variety of techniques, including Environmental Monitoring, Microbial Identification, Media prep, Water Sampling, pH testing, density testing, Protein concentration testing.
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
Biopharmaceutical QC experience in a microbiology lab
Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products
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 skillsEscalate issues professionally and on a timely basis
Technically strong background in microbiology and aseptic manufacturing
Experience in LIMS, Change 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 resultsWorks under minimal directionWork is guided by objectives of the department or assignmentFollows 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 problemsDemonstrated leadership and communication skillsAuditing documentation and operation processDemonstrated ability to interact with regulatory agencies
Specific Job Duties :
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.