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
+ 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
