Description
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
+ Water sampling
+ Testing of In Process samples such as pH
+ Initiate and/or implement changes in controlled documents.
+ Participate in audits, initiatives, and projects that may be departmental or organizational in scope.
**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 working in an aseptic cleanroom performing Environmental Monitoring
+ 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.
