Career Category
Quality
Job 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
.