This role will support manufacturing operations on a 24/7 shift pattern and may include extended hours.
Specific Job Duties:
Environmental Monitoring of Grade 8/9 Cleanrooms
Environmental Monitoring of Grade 5/7 Cleanrooms & Isolators
Reading of Environmental Monitoring Plates
Bioburden testing of water & disinfectants
Writing technical reports
Water sampling
Testing of In Process samples such as Density & pH
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 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
Basic Qualifications
Bachelor's 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
Minimum three years' Biopharmaceutical QC experience in a microbiology lab, working as part of an Environmental Monitoring team who directly support manufacturing in a Grade A/B area
Proficient in the use of LIMS & LMES
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
Competencies
Technically strong background in microbiology and aseptic manufacturing
Experience in LIMS, Change Control, Trackwise, SAP and CDOCS an advantage
Flexibility – the EM role often encounters changing priorities on a daily basis
Problem solving skills
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
Auditing documentation and operation process
Demonstrated ability to interact with regulatory agencies
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